Meetings/Workshops on Regulation in Medicine and Pharmacology in the United States (USA)

Conference-Service.com offers, as part of our business activities, a directory of upcoming scientific and technical meetings. The calendar is published for the convenience of conference participants and we strive to support conference organisers who need to publish their upcoming events. Although great care is being taken to ensure the correctness of all entries, we cannot accept any liability that may arise from the presence, absence or incorrectness of any particular information on this website. Always check with the meeting organiser before making arrangements to participate in an event!

Meeting organisers can submit meetings free of charge for inclusion into the listing.

1.
 
Reinventing Remote Monitoring to Improve Clinical Trial Quality - By AtoZ Compliance
ID
879398
Start date
30 Mar 2017
Location
New Hyde Park, United States
Contact
AtoZ Compliance;     Phone: [8444141400];     Email: referrals@atozcompliance.com
Topics
falsified data in clinical trials, chamberlain clinical methods, avail clinical research, clinical trial monitoring Strategies, Clinical Trial Quality, clinical trials remote monitoring
2.
 
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
ID
876822
Dates
30 Mar 2017 - 31 Mar 2017
Location
Tampa, United States
Abstract
The globalization of the pharmaceutical supply chain has led increased us of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it can present unique compliance risks, particularly since the operations are not in your facility and therefore not under your direct control. The compliance risks are highlighted by FDA Warning Letter trends, the majority of which are related to serious compliance and data integrity issues at foreign CMO sites.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
contract manufacturing pharmaceutical, CMO Oversight in Pharma Industry, CMO compliance, CMO business model, CMO Qualification Audit
3.
 
Understanding the Statistical Considerations for Quantitative ICH Guidelines
ID
876939
Dates
30 Mar 2017 - 31 Mar 2017
Location
Orlando, United States
Abstract
This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts with reference to certain quantitative ICH Guidelines that apply across laboratory (drug development) and clinical development (drug/device) procedures such as analytical methods in validation and acceptance criteria in calibration procedures, risk management and process monitoring as well as dealing with uncertainties and other relevant issues. It is not a course in statistics but introduces the participant to a hands on approach to the statistical techniques one uses, how they are applied and reasonably interpreted and understood. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Statistical considerations for quantitative ich guidelines training, quantitative measurement procedures, sensitivity of the sample size
4.
 
How you can prevent microorganism contamination -By AtoZ Compliance
ID
897752
Start date
04 Apr 2017
Location
New Hyde Park, United States
Contact
AtoZ Compliance;     Phone: [8444141400];     Email: referrals@atozcompliance.com
Topics
site master file fda, fda environmental monitoring, fda ectd, gmp webinar, cgmp audits, pharmaceutical compressed air-quality gmp requirements, equipment validation plan, fda system validation, computer system validation fda, tmf in clinical research, fda validation training, fda gmp compliance, fda cgmp compliance
Event website
5.
 
Supplier Management for Medical Device Manufacturers
ID
876907
Dates
06 Apr 2017 - 07 Apr 2017
Location
San Francisco, United States
Abstract
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide components to the device manufacturer, which means that they are critical to performance and delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Supplier management, supplier selection, medical device manufacturers, FDA quality system regulations, ISO 13485 requirements, supplier classification system
Related subject(s)
6.
 
How to Develop HIPAA Policies and Procedures — Developing HIPAA Policies and Procedures
ID
880807
Start date
10 Apr 2017
Location
Fremont, United States
Abstract
Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. A HIPAA Risk Management plan is your overall policies and procedures manual. If audited or the subject of a compliance review you will be required to show the government you have all the necessary policy and procedure documentation in place to address all the required safeguards. If audited by HHS, being able to demonstrate HIPAA compliance will involve providing many of these policies and procedures. Having a fundamental understanding of a HIPAA compliance helps to know what is required to implement those policies and procedures.
Contact
Roger Steven;     Phone: [1-800-385-1607];     Email: support@mentorhealth.com
Topics
hipaa, hipaa privacy rule, hipaa standards, hipaa security compliance, hipaa release form, Hipaa Webinars, Healthcare Trainings, Online Healthcare Training, webinar on HIPAA policies and procedures
7.
 
FDA & CFIA 2016 Regulatory Changes/Updates - By AtoZ Compliance
ID
882047
Start date
13 Apr 2017
Location
webinar, United States
Abstract
This webinar will cover the 2016 regulatory changes and updates for the FDA(US Food and Drug Administration) compliance programs and the CFIA (Canadian Food Inspection Agency) since 2016 is a banner year for updates and changes for both agencies.
Contact
AtoZ Compliance;     Phone: [8444141400];     Email: referrals@atozcompliance.com
8.
 
US GCP Fundamentals for Pharmaceutical and Biologic Companies
ID
876776
Dates
20 Apr 2017 - 21 Apr 2017
Location
San Francisco, United States
Abstract
Good Clinical Practice (GCP) is a term used to describe a collection of various FDA regulations that govern the conduct of clinical trials. It includes regulations which apply to Sponsors and Contract Research Organizations (CROs) who run the trials, the clinical trial sites and Investigators who conduct the research, the Institutional Review Boards (
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA GCP inspections, good clinical practices seminar, GCP compliance, clinical trial sites, IRBs, good manufacturing practice, GMP, FDA inspection management
9.
 
FDA Scrutiny of Promotion and Advertising Practices
ID
876761
Dates
20 Apr 2017 - 21 Apr 2017
Location
Tampa, United States
Abstract
If you go
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
fda's advertising and promotion requirements, fda regulations for labelling, fda warning letter, fda legal authority, ftc, mass media, doj, off label, fda guidance
10.
 
How to get a CLIA Waiver for your Medical Device
ID
876868
Dates
20 Apr 2017 - 21 Apr 2017
Location
San Francisco, United States
Abstract
FDA has granted precious few applications for waiver since their CLIA Waiver guidance was published on January 30, 2008. Between 2008 and 2012, FDA reviewed 34 applications for CLIA Waiver and approved 14, sometimes taking years to issue a denial. The cost of performing CLIA Waiver studies, combined with the lengthy review times and likelihood of failure, has discouraged companies from bringing new innovations to this critical public health sector.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
CLIA waiver training program, fda 2008 clia waiver guidance, clia waived products labeling, ate and ler zones, clia categorization criteria
11.
 
eCTD Submissions Seminar — eCTD Submissions of IND and NDA/BLA to the US FDA: Hands-on Workshop
ID
882700
Dates
20 Apr 2017 - 21 Apr 2017
Location
Boston, United States
Abstract
Starting 5 May 2017, FDA will require all DMFs be submitted only in the electronic CTD format creating a huge burden on owners of most submissions. Converting to eCTD format requires special skills, software and resources, the cost of which could be prohibitive to small manufacturers. Our speaker, Dr. Mukesh Kumar, in this workshop will go over the details of the latest guidance on eCTD submission and explain the key takeaways. The trainers will use their own case studies of how eCTD submissions were created and successfully submitted to the FDA using indigenous tools and expertise. Also discussed will be logistical issues associated with managing and maintaining eCTD compliance with regards to all regulatory submissions. This workshop will be beneficial to both the novices and experienced in the field.
Contact
Peter Brown;     Phone: [410-501-5777];     Email: pbrown@fdamap.com
Topics
eCTD Submission, eCTD Workshop, eCTD Guidance, FDA Submission, FDA Regulations, FDA eCTD Compliance, FDA Compliance
12.
 
Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits
ID
878159
Dates
04 May 2017 - 05 May 2017
Location
Pittsburgh, United States
Abstract
This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years’ experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions. During the seminar, Ms. Hoffman will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, how and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall. She will also discuss how to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
medical device recalls seminar, medical device regulations seminar, medical device reporting, medical device complaint management, medical device complaint handling
13.
 
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
ID
878147
Dates
11 May 2017 - 12 May 2017
Location
San Francisco, United States
Abstract
The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
PV Audit Strategy Planning, The European Medicines Agency's (EMA) Guideline, Good Pharmacovigilance Practices (GVP), risk-based audits, GVP Modules, PV Universe
14.
 
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
ID
878179
Dates
15 May 2017 - 16 May 2017
Location
Boston, United States
Abstract
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs). These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidances, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The lifecycle concept, new to these Guidances, link product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. These guidances also support process improvement and innovation through sound science and risk management. The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA Process Validation Guidance, EU Annex 15, Active Pharmaceutical Ingredients (APIs), International Conference on Harmonization (ICH)
15.
 
Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC)
ID
878167
Dates
16 May 2017 - 17 May 2017
Location
Philadelphia, United States
Abstract
This interactive one-and-a-half-day seminar is intended to educate regulatory and quality professionals regarding the rather complicated regulations that distinguish Non-prescription Drugs from other products such as foods, cosmetics, dietary supplements and prescription drugs that sometimes contain the same ingredients. Recent FDA actions such as the banning of antibacterial soaps and ongoing programs that may impact manufacturers and private label distributors will be discussed. It will explain differences in the way homeopathic and conventional drugs are regulated and update participants on FDA’s application of GMP regulations to manufacturing low risk drugs that could be sold as cosmetics with the same ingredients, but different labeling. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Cosmeceuticals, dietary supplements, cosmetics, homeopathic OTCs, FDA regulations, FDA GMPS, good manufacturing practices, over the counter, low risk OTC drugs, warning letters, FDA enforcements actions, FDA marketing regulations
16.
 
GMP Compliance for Quality Control and Contract Laboratories
ID
878100
Dates
16 May 2017 - 17 May 2017
Location
Sydney, United States
Abstract
This program will cover the requirements for laboratory controls under US GMP regulations and compare them to those applied by other international health regulatory authorities. Laboratory controls relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues will be included under laboratory controls. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Quality Control Lab regulations, contract laboratories, US GMP regulations, analytical method validation, change control, data integrity, laboratory inspection
17.
 
Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2015/2016)
ID
878165
Dates
18 May 2017 - 19 May 2017
Location
Boston, United States
Abstract
Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore with a greater frequency than usually observed within the United States. A lack of Data Integrity hints of a Company being outside of compliance and questions the quality of the product being produced. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Data Integrity program, cGMP compliance, regulatory requirements FDA, WHO, EMA, Data integrity workshop, data integrity issues
18.
 
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
ID
878208
Dates
18 May 2017 - 19 May 2017
Location
Tampa, United States
Abstract
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA GMP workshop, FDA GMP Expectations, Phase I, First-in-Man Clinical Trials, CMC Requirements, IND Study, Raw Material Management
Related subject(s)
19.
 
Quality Control Laboratory Compliance - cGMPs and GLPs
ID
878185
Dates
18 May 2017 - 19 May 2017
Location
Philadelphia, United States
Abstract
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Quality Control Lab regulations, QC Lab regulations, FDA QC Lab requirements, FDA lab regulations, Good Laboratory Practices, GLP, cGMP, Current Good Manufacturing Practices
20.
 
Product Information for Medicinal Products in the EU
ID
878151
Dates
18 May 2017 - 19 May 2017
Location
Vienna, United States
Abstract
SmPCs are the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients. By attending this training you will learn documentation, regulation and regulatory affair aspects of medicinal product labelling and packaging in the EU. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
EU medicinal product information guidance, SmPC labelling text, package leaflet, SmPC marketing authorisation, medicine safety requirements in EU, pharmacovigilance (PV) document, EMA/CHMP guidance documents
21.
 
Data Integrity: FDA/EMA/TGA Requirements and Implementation
ID
883681
Dates
18 May 2017 - 19 May 2017
Location
Sydney, United States
Abstract
The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pharmaceutical regulatory authorities have. Enforcement penalties can be severe from a business standpoint, and in extreme cases can even impact individuals who are held responsible for the occurrence of data integrity problems. In recent months the topic of data integrity has been in the forefront of concern among worldwide pharmaceutical regulatory agencies. The FDA, EMA, TGA and others have published guidelines setting forth their requirements and expectations for the maintenance of data integrity, as has at least one leading industry organization (PDA).
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
pharma data integrity, GMP, GCP, GLP, FDA, EMA, TGA regulations, data acquisition, ALCOA, Generic Drug Scandal, GXP operations
22.
 
Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)
ID
883713
Dates
18 May 2017 - 19 May 2017
Location
New Orleans, United States
Abstract
This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Latin America regulations, Latin America life sciences regulations, Latam life sciences regulatory requirements, Latin America pharmaceutical regulations, Latin America medical device regulations, Latin America biologics regulations
23.
 
Auditing for Medical Device and Pharma Companies – A Tool to Reduce Quality and Compliance Risk
ID
883781
Dates
25 May 2017 - 26 May 2017
Location
Boston, United States
Abstract
This 2-day seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, many companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well-planned audit program can reduce these risks. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Pharma and medical device internal auditing, internal audit program, FDA's expectations, documentation, risk analysis techniques, audit program structure
24.
 
The Veterinary Drug Approval Process and FDA Regulatory Oversight
ID
883868
Dates
01 Jun 2017 - 02 Jun 2017
Location
Kansas City, United States
Abstract
The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. However, FDA does not regulate all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA veterinary drug approval process, center for veterinary medicine, new animal drug application, investigational new animal drug (INAD) file, animal disease diagnostic devices, veterinary medicine regulations, veterinary drug user fees, Agriculture’s Animal and Plant Health Inspection Service
25.
 
Pre-Filled Syringes West Coast
ID
877327
Dates
05 Jun 2017 - 06 Jun 2017
Location
San Diego, United States
Abstract
SMi Group are thrilled to announce the return of Pre-Filled Syringes West Coast 2017 which arrives to California on June 5th & 6th.

Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will once again gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advances, keeping you at the forefront of a booming industry. The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing and complex biologics, whilst honing in on emerging trends for parenteral devices, including auto injectors, pens, pumps and smart devices. We will also be welcoming expertise from the likes of Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon, Allergan, MedImmune, Xeris Pharmaceuticals, Amgen, Eli Lilly, Genentech, Ferring, Roche and more.

Contact
Teri Arri;     Phone: [+44 (0)20 7827 6000];     Email: tarri@smi-online.co.uk
Topics
prefilled syringe, pre-filled syringe, autoinjector, human factors, device development, innovation, strategy, extractables, leachables, patient safety, compliance, biosimilar, parenteral, packaging, combination products, lyophilisation, freeze drying, injectable, injectable devices, syringe, extractables and leachables, E&L, PFS, drug device, drug delivery, combination products, sterilization, needle, component, glass syringe, cop syringe, container, formulation, device development, human factors, manufacturing, device technology, medical device, parenteral drug, plastic, qbd, drug delivery, infusion, vial, cop, sterilization, clogging
26.
 
Applying the FDA Food Safety Modernization Act (FSMA) to Your Organization
ID
883834
Dates
08 Jun 2017 - 09 Jun 2017
Location
Minneapolis, United States
Abstract
The Food Safety Modernization Act has introduced some of the most sweeping reforms to U.S. food safety laws in more than 70 years. It is mandated that all FDA regulated manufacturers in the United States and any foreign entity who produces food to be consumed within the US must comply to applicable final rules. This seminar offers a 360 degree view of food safety practices from a FSMA-centered approach. The courses will highlight the basics of food safety with an emphasis on compliance. The seminar will provide the tools needed to align your company’s governance, risk management, and compliance programs with new FDA regulations. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FSMA, food safety modernization act, FSMA requirements, food-borne illness, HACCP, food safety, Hazard Analysis and Critical Control Points, FDA food compliance
27.
 
3rd Annual ComplianceOnline Medical Device Summit 2017
ID
884950
Dates
08 Jun 2017 - 09 Jun 2017
Location
Boston, United States
Abstract
Innovate novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R&D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations.

Plan for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections.

Build FDA compliant quality management systems. Attend this summit to learn how to develop and implement effective, consistent and reliable quality management systems. Ex-FDA officials and senior company executives will share thoughts and ideas to improve the performance of your current system.

Interact with leading minds in the industry. Attendees will get to network with the prominent decision makers in the industry to exchange ideas, offer thoughts and know-how, and share experiences. Joining this summit will offer a unique opportunity to the attendees to market their offerings and identify new business opportunities.

Deliberate the current state of medical device laws and technology and government oversight. Panel comprising of some of leading medical device experts and veterans will discuss the recent changes to the regulatory environment for the medical device industry and how these changes will impact the approval of new devices. Attendees will gain insight into the current issues and future challenges in the industry. Join this summit to hear from the experts who have extensive experience in all aspects of medical device including R&D, manufacturing quality assurance, approval and commercialization process.

Scale factors for successful medical device commercialization. Discussions with industry veterans through real case studies will help medical researchers, healthcare professionals, industrialists and entrepreneurs better understand the criterias for successful commercialization of medical devices. This summit also offers numerous opportunities for medical device companies and suppliers to showcase their products and services to potential customers, generating leads and growing their businesses.

Enhance risk management strategies for the safe, effective and efficient use of medical devices. Medical device professionals will join together to share their knowledge and best practices for implementing good risk management principles within the industry. Attending this summit will help you to develop a robust and integrated risk management plan to improve quality management system.

Note: Use coupon code NB5SQH8N and get 10% off on registration.

Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Medical Device Summit, Medical Device Seminar, Medical Device Summit 2016, Medical Device Seminars 2016, Medical Device Conferences, Medical Device Events
28.
 
The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products
ID
883877
Dates
15 Jun 2017 - 16 Jun 2017
Location
Newark, United States
Abstract
All facilities manufacturing pharmaceuticals, biologics, medical devices, cosmetics, and personal care products are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility, it is site’s microbiologists who should understand the microorganisms in water systems and how best to monitor and control them. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance. This lack of understanding of microbial control often leads to poor system designs, poor system sampling, poor system maintenance and poor sanitization practices, and as a result, ongoing microbial problems with the water. This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement, since this training is for everyone involved with water systems, from the lab to utility room operations. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential for the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control and monitoring consists of a set of rules that often don’t work or result in erroneous monitoring data and can cause everything from very costly and unnecessary system downtime to patient injury and product recalls. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Pharmaceutical water systems seminar, water system compliance seminar, water system microbial control, water system microbial monitoring, water system validation
29.
 
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
ID
883898
Dates
15 Jun 2017 - 16 Jun 2017
Location
Boston, United States
Abstract
One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls. This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA SOP requirements, FDA SOPs, FDA regulated industry SOP types, FDA SOP components, SOP training, SOP implementation, SOP template, SOP numbering system
30.
 
Designing and Sustaining New and Existing Product Stability Testing Program
ID
883831
Dates
15 Jun 2017 - 16 Jun 2017
Location
Orlando, United States
Abstract
New or existing modified drug Stability Testing Program's regulations/requirements stipulated by the FDA, 21 CFR or other regulations may sometimes creating an overwhelming situation based on the type of product that is being manufactured. Hence, some manufacturers of new drug products have made inadvertent mistakes in the design of their new drug stability testing program. Such mistakes may ultimately delay the new, existing or modified product IND or NDA application process due to the data that was presented to the FDA (i.e. Relevant aspects of the stability testing program requirement may have been omitted by the drug manufacturers). It is better to understand, follow and apply the full requirements of a new product stability testing requirement from the onset or to correct an existing stability testing program so as to avoid future pitfalls and delayed IND or NDA submission process by the FDA. Having produced a new or existing product, knowing the appropriate way to design and perform the stability testing of the new product which is a prerequisite for setting the product's expiration date and possible extension of the expiration date is critical. Some drug product manufacturers have made mistakes in the past whereby a new product that was manufactured appropriately did not have a good stability testing plan or program hence it delayed the product's ability to have an approved IND or NDA submission. A mistake of this sort has also been made by drug manufactures that resulted in a 483 or Warning letter by the FDA. Knowing how to approach the design of a new product stability program at the onset of the new product design or during an existing product testing is important and will save a company time and cost in moving the product to the next phase. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA's Drug Stability Testing Program, NDA submission, 21CFR 514.1(b)(5)(x) expectations, Analytical Testing Considerations, Laboratory Information Management Systems (LIMS)
31.
 
Bioanalytical Methods and Good Laboratory Practices (GLP) - Essential Elements for Pre-Clinical Studies during development of Drugs
ID
883841
Dates
15 Jun 2017 - 16 Jun 2017
Location
San Francisco, United States
Abstract
Pre-clinical or non-clinical studies are required during drug development to evaluate safety in animals (toxicology) and pharmacokinetics and bioavailability (pharmacology) of drugs prior to initiating the clinical development of a drug. These studies must be performed following the Good Laboratory Practices (GLP) regulations, specified by the US FDA or principles and guidelines developed by the Organisation of Economic Co-operation and Development (OECD). Regulations for the GLP, specified in 21 CFR 58, related guidelines, including “questions and answers” documents, a training handbook and training manuals developed by the World Health Organization (WHO) are available to clarify the regulatory expectations with a view to assisting the sponsors of drugs and contract testing laboratories performing toxicology and pharmacology studies in complying with these regulations. Despite these guidance documents and training materials, GLP regulations are one of the most commonly misunderstood regulations for drug development and manufacturing operations with a number of myths about GLPs. This course will explain various elements of GLPs in detail with a view to comply with the regulations and Law as per regulatory requirements and expectations. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Drugs development requirement, bioanalytical methods, good laboratory practices, GLP, GMP, 21 CFR 58, GLP regulations, pharmacokinetics, bioavailability
32.
 
FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements
ID
883928
Dates
15 Jun 2017 - 16 Jun 2017
Location
New Jersey, United States
Abstract
This course is intended for employees who need a basic understanding of the FDA rules and regulations for pharmaceuticals. It will cover the basics of various ways to bring a product to market as well as Current Good Manufacturing Practice (cGMP). Items to be discussed include Over-the-Counter (OTC) Monographs, New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), product development overview, Investigational New Drugs (INDs), concepts in clinical trials and bioequivalence trials, amendments and supplements to applications, analytical method and process validation, cGMPs and FDA Inspections. The course is not intended to prepare a student to create any of the matters discussed. Rather it is intended to give the student enough knowledge so that he or she can intelligently participate in discussions of strategy and assignment of resources. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA requirements for the pharmaceutical industry, FDA pharma compliance, current good manufacturing practice (cGMP), over-the-counter (OTC) monographs
33.
 
HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
ID
883850
Dates
15 Jun 2017 - 16 Jun 2017
Location
San Francisco, United States
Abstract
With the recent implementation of new HIPAA regulations in the HIPAA Omnibus Update of 2013, healthcare organizations are reviewing their compliance and making sure they have the proper policies, procedures, and forms in place. HIPAA Privacy Officers have been renewing their compliance activities and reviewing their documentation to make sure they can meet the challenges of the new rules and avoid breaches and penalties for compliance violations. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
HIPAA privacy rule, HIPAA regulations, HIPAA compliance
34.
 
Effectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues
ID
883926
Dates
19 Jun 2017 - 20 Jun 2017
Location
Orlando, United States
Abstract
This seminar will guide the attendee in effectively handling, addressing and remediating FDA's and other related compliance issues associated such as FDA's Form 483, Warning Letter and Consent Decree Compliance Findings. An effective handling and resolution of Compliance issues will prevent further disciplinary actions such as an FDA's Warning Letter or a formal Consent Decree which ends with a costly impact, fines and possible injunctions by the FDA. Because the impact of non-compliance and remediation of compliance issues are very costly, time consuming and impacting to a business and associated manufactured product including an increasing severity of disciplinary action by the FDA, understanding the triggers, effective preventative and corrective actions and an effective and expedient resolution of such compliance issues will assist a manufacturer of product in preventing expensive remediation of compliance issues, delays to product launch, impact on current commercially available product, overall business reputation, product recall, Fines, loss of impacted Product, loss of business licensure and/or prosecution by the FDA. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA Form 483 Warning Letters, FDA Consent Decree, FDA injunction, Code of Federal Regulations, FDA Form 483 Seminar
35.
 
FDA's New Import Program for 2017 - Strict Precision
ID
885026
Dates
22 Jun 2017 - 23 Jun 2017
Location
San Francisco, United States
Abstract
The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. When and how you use these programs can make a big difference in the net profit derived from even a single shipment. The new Voluntary Qualified Importer Program (VQIP) is one such example. Another example is CBP’s and FDA’s implementation of the Automated Commercial Environment (ACE) program became mandatory for importers in 2016. If you fail to correctly use new import procedures and programs, you will be operating under an expensive disadvantage. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA import regulations, FDA’s import legal requirements, U.S. Customs and Border Protection, CBP requirements, FDA warning letter, FDA import program, risk of detention
36.
 
Statistical Analysis for Product Development
ID
884992
Dates
12 Jul 2017 - 13 Jul 2017
Location
San Francisco, United States
Abstract
This course is designed to help scientists and engineers understand the statistical methods used in process and product development. Variability is part of every process, design of experiments helps to separate systematic variability from special cause variability. You will get a chance to examine the different sources of variability how it relates to analytical method development, process improvement and sample size selection. The concept of experimental budget will be introduced to help you plan the total number of experiments needed. You will also learn to improve process output characteristics including quality, cost, and robustness through generating empirical models of your processes in the fewest experiments possible. This highly interactive course will allow participants the opportunity to develop strategies for analysis of experimental data. The objective is to provide participants with key technical information along with perspectives to enable them to apply the technologies to their own projects and evolve their own statistical methods to support the various stages of product development. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Statistical Analysis, product development, statistical methods, variability, design of experiments, systematic variability, special cause variability, analytical method development, process improvement, experimental budget
37.
 
Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products
ID
878149
Dates
13 Jul 2017 - 14 Jul 2017
Location
Minneapolis, United States
Abstract
Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. While Medical Devices, Pharmaceuticals, and Combination Products have had unique histories for the evolution of risk management, the management of compliance risk is a common business process for all three areas. Enterprise Risk Management (ERM) is the generic term for managing the risks of an organization. ISO 31000 is the ERM ISO Standard. This standard provides guidance for organizations on implementing ERM solutions. ISO 9001 is the Quality Systeme Standard. ISO 9001 now requires to establish “risk-based thinking.” As a result, ISO 13485, the International Quality System Standard for Medical Devices, has been revised to include requirements for firms to implement Compliance Risk Management. These requirements are in addition to the requirements as currently defined by ISO 14971, the International Standard for Risk Management of Medical Devices.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Enterprise Risk Management (ERM) Training, ISO 31000, ERM solutions, ISO 14971 Training, medical device risk management training, Compliance Risk Management
Related subject(s)
38.
 
Understanding the FDA's Regulation of HCT/Ps and Successful Product Development Strategies
ID
885035
Dates
13 Jul 2017 - 14 Jul 2017
Location
Irvine, United States
Abstract
In 1997, the FDA proposed a comprehensive regulatory program for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/Ps) outlining the registration and listing procedures for HCT/Ps. This program also differentiates between HCT/Ps that will be regulated via the traditional pathway and those that will undergo approval as new drugs, biologics or devices. In this seminar, we'll discuss the historical context for the use of HCT/Ps in medicine as well as how the HCT/P market is evolving. You will be shown examples of the FDA-approved use of HCT/Ps and what is required for successful product development. This course will also provide an overview of the health authority regulating HCT/Ps, discuss the regulations that govern HCT/Ps, discuss potential product development strategies and provide an overview of product development in the United States. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA regulatory oversight of HCT/Ps, tissue reference group, approval process, good tissue practice, good manufacturing practice, quality system regulations, good laboratory practice, FDA enforcement actions, adverse event reporting, homologous use, adipose tissue, translation medicine
39.
 
Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products
ID
884990
Dates
13 Jul 2017 - 14 Jul 2017
Location
Minneapolis, United States
Abstract
Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. While Medical Devices, Pharmaceuticals, and Combination Products have had unique histories for the evolution of risk management, the management of compliance risk is a common business process for all three areas. Enterprise Risk Management (ERM) is the generic term for managing the risks of an organization. ISO 31000 is the ERM ISO Standard. This standard provides guidance for organizations on implementing ERM solutions. ISO 9001 is the Quality Systeme Standard. ISO 9001 now requires to establish “risk-based thinking.” As a result, ISO 13485, the International Quality System Standard for Medical Devices, has been revised to include requirements for firms to implement Compliance Risk Management. These requirements are in addition to the requirements as currently defined by ISO 14971, the International Standard for Risk Management of Medical Devices. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Enterprise Risk Management (ERM) Training, ISO 31000, ERM solutions, ISO 14971 Training, medical device risk management training, Compliance Risk Management
40.
 
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies
ID
885022
Dates
13 Jul 2017 - 14 Jul 2017
Location
Irvine, United States
Abstract
Stem cells harness the power to differentiate into numerous cells upon stimulation. This has led to their wide exploration across all of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications. This tutorial will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in industry on how such therapies should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Regenerative medicine regulations, Stem Cell Treatments, biomaterials, FDA regulates regenerative treatments and therapies, good manufacturing, good laboratory practices
41.
 
A Comprehensive View of FDA Regulations for Medical Devices
ID
885087
Dates
20 Jul 2017 - 21 Jul 2017
Location
Cambridge, United States
Abstract
Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820. Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.” Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
US medical device regulations, FDA medical device compliance best practices, FDA QSR, medical device reports (MDR), Unique Device Identification (UDI), Quality System Inspection Technique (QSIT), FDA inspections, medical device manufacturer
42.
 
FDA Recalls - Before You Start, and After You Finish
ID
885108
Dates
03 Aug 2017 - 04 Aug 2017
Location
Salt Lake City, United States
Abstract
FDA's recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves the identification of the root cause of the recall and how you could or should prevent that problem from happening again. Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that,
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA Recall, FDA recall classes, FDA recall guidance, FDA recall procedures, regulatory management, CAPA, FDA inspection, Recall Regulations, Mandatory recall actions
43.
 
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
ID
885107
Dates
12 Sep 2017 - 13 Sep 2017
Location
Boston, United States
Abstract
Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated. Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Laboratory compliance, Analytical methods, data, procedures, compendial methods, Method validation and transfer, equivalency testing, FDA inspection, SOPs, FDA and EU compliance
44.
 
FDA's Medical Device Software Regulation Strategy
ID
885073
Dates
21 Sep 2017 - 22 Sep 2017
Location
Boston, United States
Abstract
The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Seminar by Ex-FDA Official, Regulatory profile for software products, FDA mobile apps regulation, medical device software functionality, FDA and NIST software guidance
45.
 
22nd International Conference of FFC- Functional Foods and Chronic Diseases: Science and Practice
ID
876635
Dates
22 Sep 2017 - 23 Sep 2017
Location
Boston, United States
Abstract
Functional Food Center is pleased to announce its 22nd International Conference
Contact
Email: ffc@functionalfoodcenter.com
Topics
functional foods, chronic diseases, diabetes, CVD, obesity, cancer
46.
 
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
ID
885105
Dates
09 Nov 2017 - 10 Nov 2017
Location
Cambridge, United States
Abstract
Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena. What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA training seminar, FTC advertising seminar, advertising drugs, advertising medical devices, promotion drugs, promoting medical devices, FTC advertising rules

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Last updated: 29 March 2017