Conférences - Législation en médecine et pharmacologie

Complianceonline

This course is designed to cater for employees of pharmaceutical companies who would like an understanding of the drug development and regulatory approval process. The course starts by considering the global pharmaceutical market, important therapeutic areas and the roles of different pharmaceutical professionals in the development process, as well as a definition of drugs and medical devices. The drug development process, from discovery to post-marketing surveillance, is then explained. Topics include the identification of drug targets, synthesis of chemical drugs and the development of biologics, pharmacokinetics and toxicity screening, pre-clinical development, clinical studies, regulatory submissions, managing post-approval change, pharmacovigilance and an overview of regulations governing drug manufacture and distribution.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Drug development process, identification of drug targets, synthesis of chemical drugs, the development of biologics, pharmacokinetics, toxicity screening, pre-clinical development, clinical studies, regulatory submissions, managing post-approval change, pharmacovigilance, governing drug manufacture and distribution fda regulations, global pharmaceutical market size

Complianceonline

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Part 11, Annex 11, validation, software validation, electronic signatures, computer system validation, CSV, SaaS, cloud hosting, Warning Letters, 483, FDA

Complianceonline

This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Process, Mapping, for, Risk, Based, P, PC, Using, Lean, Six, Sigma, and, HACCP, ComplianceOnline

Complianceonline

This webinar will explain the Civil Monetary Penalties Law (CMP) and its mandatory and permissive exclusions and penalties. It will also cover obligations under EMTALA, violations of the Anti-Kickback Statute and Stark including amendments under the PPACA.

Civil monetary penalties law, emergency medical treatment and labor act, EMTALA, anti-kickback statute, stark law, patient protection and affordable care act, false claims act, OIG exclusion list

Complianceonline

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Complianceonline

This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

computer systems validation, computer systems validation training, computer systems validation seminar, csv seminar, computer system validation compliance, computer systems validation regulations, computer systems validation courses, computer systems validation fda, compliance online software training, computer systems validation class room training in the united states

Complianceonline

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable. One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan. Health Canada has now made the MDSAP process mandatory for all licensed products in Canada.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

global medical device regulations seminar, medical device single audit program mdsap, GMP audit, mdsap audit, device classification, licensing pathways, medical device gmp, device labeling, medical device single audit program, medical device single audit program mdsap, fda medical device single audit program, medical device single audit program canada

Complianceonline

This two day highly interactive course will cover all aspects of radiation sterilization validation, materials selection and processing implementation. This workshop has been designed to help attendees learn the ins and outs of all the radiation modalities, materials selection, and validation of the sterilization process per ISO 11137. Additionally, 483 case studies will explore how to avoid the operational and legal issues that arise from nonconformance with regulators (FDA) and auditors.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Radiation sterilization for medical devices, sterilization validation, gamma radiation sterilization, E-beam sterilization, X-ray sterilization, irradiator designs, ISO 11137 requirements

Complianceonline

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.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

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, FDA form 2877, CPB form 3461, medical device affirmations of compliance

Complianceonline

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

21 CFR Part 11 Compliance, Annex 11 Compliance, Avoid 483s, Warning Letters, 10-step risk-based validation approach, COTS software validation

Complianceonline

This 2-day virtual seminar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls! This virtual seminar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control. You’ll learn about the essential elements of purchasing control and how you can translate them into your procedures. We’ll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities. Inadequate supplier/purchasing control can lead to a multitude of problems including rejections or delays at receiving inspection; non-conformances and scrap on your manufacturing lines; and quality problems that can manifest later in the field resulting in MDRs and recalls. Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continue to be a leading source of 483 and Warning Letter citations. This course will examine real-life warning letters to deepen your understanding of important concepts

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Supplier management, supplier selection, medical device manufacturers, FDA quality system regulations, ISO 13485 requirements, supplier classification system, supplier management plan, supplier controls, supplier measurement systems, supplier monitoring systems, supplier business risk, supplier regulatory risk, design control, design transfer, and purchasing data, regulatory risk model, business risk model, global harmonization task force, GHTF framework

Cambridge Healthtech Institute (CHI)

This conference is designed to facilitate knowledge and opinion exchange between pharmaceutical and diagnostics executives, translational scientists, clinicians, business experts, regulators, international companion diagnostics leaders, and other parties involved in drug-diagnostics co-development and precision medicine. Case studies of successful collaboration between pharmaceutical and diagnostics companies will be presented. This conference is part of the Next Generation Dx Summit.

Tél.: [781-972-5400];     Email.: reg@healthtech.com

drug, diagnostics, drug-diagnostics, medicare, drug reimbursement, diagnostic reimbursement, technology, technologies, lab tests, pharmaceuticals, biomarkers, immuno-oncology, precision medicine

Biotechnologie,    Génie biomédical

Cambridge Healthtech Institute (CHI)

At this conference, leaders working in the clinical lab, research, biotech, and pharma will come together to showcase the latest in diagnostic technology and find solutions for the biggest challenges facing the clinical lab, including managing workflow, incorporating NGS and molecular testing, gaining reimbursement and regulatory approval, and more. This conference is part of the Next Generation Dx Summit.

Tél.: [781-972-500];     Email.: reg@healthtech.com

diagnostics, advanced diagnostics, infectious diseases, infectious disease testing, molecular diagnostic test, MDx test, COVID-19, CRISPR, pandemics, POCT

Biotechnologie,    Biologie

Complianceonline

This program combines general considerations for Good Manufacturing Practice (GMP) compliance management with the principles of phase-appropriate GMP considerations, with an emphasis on needs of virtual companies. (“Virtual companies” are those who outsource GMP operations to Contract Manufacturing Organizations (CMOs) and Contract Analytical Laboratories.) Virtual companies typically do not conduct “hands on” manufacturing, but do perform tasks which are governed by GMP, for example, dispositioning final product, managing the supply chain, investigating complaints, and providing training to staff in GMP compliance concepts. Such companies often struggle to decide how to structure their quality management system, which procedures they need or do not need, and how to best manage vendor relationships. In addition, the application of GMP requirements to the manufacture of investigational products requires exercise of judgement over the life cycle from early phase (Phase 1) to peri-approval (late Phase 3). Understanding what is required by FDA and other regulatory agencies is important to assure timely approval, since GMP compliance issues can result in approval delays. In this two half-day workshop conference you will learn how GMP applies directly to virtual company operations, how to best structure a quality management system in a virtual company, and a method to decide which procedures are necessary at what points in time. You will also learn best practices for quality agreements and vendor management. In addition, you will learn the current guidance from FDA for application of GMP to the manufacture of Phase 1, 2 and 3 clinical trial materials. Though FDA requirements are the primary emphasis, some discussion of EMA (European) requirements and other venues will also be included.

phase appropriate gmp, fda gmp workshop, FDA GMP Expectations, Phase I, First-in-Man Clinical Trials, CMC Requirements, IND Study, Raw Material Management, 505(b)(2) Products process Validation, ISO 9001:2015 QMS, Combination Products

Complianceonline

Complianceonline

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to data integrity, and how to improve your practices to meet compliance requirements.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

gxp systems, gmp, glp, gcp, probability of occurrence, severity of impact, detectability, mitigation, procedural controls, technical controls, risk scenario, risk assessment, risk rating, risk management, gamp 5 system categorization, good documentation practices, quality assurance, data integrity, alcoa (attributable, legible, contemporaneous, original or “true” copy, accurate), system and data governance, fda warning letter, fda consent decree, validation planning and execution, installation qualification (iq), operational qualification (oq), performance qualification (pq), fda regulations, fda trends and influences, fda oversight, computer system validation (csv), system development life cycle (sdlc) methodology, 21 cfr part 11 (electronic records/ electronic signatures)

Complianceonline

Dear colleagues, partners and friends, on behalf of the Scientific Committee and the Center of Pharmaceutical Engineering I cordially invite scientists, researchers and professionals from industry, academia and research institutions to the 4th International Symposium on Pharmaceutical Engineering Research – SPhERe – from September 15 – 17, 2021 in Braunschweig, Germany. Due to the ongoing threats by the Corona virus and the unforeseeable situation following the summer travelling season, SPhERe 2021 will take place in a completely online format.

SPhERe addresses major issues on innovative methods and processes to develop and manufacture effective and customized drugs in a cost-efficient manner. Bringing together pharmacists, process and production engineers as well as microtechnologists from academia and industry, the conference will promote multidisciplinary exchange and collaboration.

Processes for Biological APIs, Processes for Chemical APIs, Continuous Processing, Solid & Liquid Preparations, Formulation, Materials & Analytics, Microsystems & 3D printing,

Pharmacologie et développement des médicaments,    Génie biomédical

Complianceonline

Complianceonline

Complianceonline

Complianceonline

SMi Group

The aseptic processing industry has seen many changes during its progression towards the 21st century. With advances in innovative therapeutic manufacturing such as ATMPs, pragmatic barrier system applications, adaptability and modularity in fill finish, robotics and automation, small and agile product manufacturing, just to name a few. In 2018, the global aseptic processing market was valued over $56 trillion and is estimated to increase in net revenue upwards $124 trillion by 2027, with a CAGR growth of 9.18%. The industry is ever changing and with the advent of innovative therapeutics taking hold, regulators and industry leaders are prompted to take proactive approaches to get treatments to patients faster. Join us to explore novel and developing technologies that tackle the most pressing challenges and push innovation in the world of aseptic processing and sterile manufacturing.

Simi Sapal;     Tél.: [02078276162];     Email.: ssapal@smi-online.co.uk

Aseptic Processing, Pharmaceutical Aseptic Processing, Environmental Monitoring, EM, ATMP, Advanced Therapy Media Fill, GMP, Contaminant Particles, Medicinal Product, Pharmaceutical Microbiology, Fill Finish, Media Fill, Isolators, Microbiology, Aseptic Technique, Sterility, Bioburden, Mycoplasma, Quality Control, Rapid Microbial Methods, Data Integrity, Risk Assessments, Endotoxins, Microbiome, Bacteria, microbiota, metagenome, microorganisms, sterility, aseptic, organisms, biotech, quality control, quality assurance, antibiotics, pathogenic, diseases, bacteria, protozoal parasites, viruses, fungi, biotechnology, genetic engineering, vaccines, dna, sterility, sterile, sterilization, environmental monitoring, rapid, RMM, contamination, endotoxins, pyrogen, contaminants, cleanroom

Pharmacologie et développement des médicaments,    Biotechnologie

Complianceonline

Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP regulations affecting pharmaceutical quality control, this one-day course is designed to provide the non-specialist with the necessary knowledge to understand the quality significance and risk associated with different analytical operations.

Lab safety audit checklist, laboratory audit checklist, chemical laboratory audit checklist, pharmaceutical quality assurance, pharmaceutical guidelines for quality assurance, quality control of drugs, gmp guidelines for pharmaceuticals, laboratory inspection

Complianceonline

In this two day workshop conference you will learn the different global agencies expectations of equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors.

Equipment Qualification, DQ, IQ, OQ, PQ, Validation Processes, Change Control, Validation Master Plan (VMP), SOPs, QMS, Risk Analysis, FDA Warning Letters, case Study, FDA Compliance Seminar

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

brazil medical products regulation conference, 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, Argentina life sciences regulations, Argentina medical device regulations, Argentina biologics regulations, Brazil life sciences regulations, Brazil medical device regulations, Brazil biologics regulations, Mexico life sciences regulations, Mexico medical device regulations, Mexico biologics regulations, Latin America clinical requirements, Latin America pre-clinical requirements

SMi Group

Conference: 6 – 7 October 2021

London, UK (virtual attendance option available)

SMi Group are pleased to announce the 2nd Annual Next Generation Pharmaceutical Cleanroom Conference. An event that focuses on cleanroom technology in the pharmaceutical industry, the conference will serve to bridge that gap between the two areas while simultaneously providing a unique selling point. This one-of-a-kind meeting will facilitate networking opportunities with key opinion leaders from all areas of pharmaceuticals, biologicals, and cleanroom industry experts to explore hot topics within cleanroom design and engineering, best practices and regulation, environmental and contamination control, and pharmaceutical microbiology. In 2025, the global cleanroom technology market is expected to reach nearly $5 billion. Stringent regulatory standards for product approvals, technological advancements in cleanrooms, initiatives taken by private organisations to create awareness regarding cleanroom and growth of the healthcare sector globally are among the few factors expected to drive the market. This event will look in-depth at the significant change that the cleanroom industry is going through. From the new operating practices that keep the product as sterile as possible, to the developments in technology that are enabling this to happen. Whether through robotics, automated disinfection, or data driven environmental monitoring- this conference will highlight the developments that are fundamentally changing the industry.

Simi Sapal;     Tél.: [07800890224];     Email.: ssapal@smi-online.co.uk

Cleanroom, Pharmaceutical Cleanroom, Annex 1, ISO 14644, GMP, RMM, Rapid Micro Methods, Contamination recovery rates, Cleanroom, Mycoplasma, Data Integrity, Environmental monitoring, HVAC system, Contamination Control, RABS, restricted-access barrier system

Pharmacologie et développement des médicaments,    Formation médicale continue (FMC)

Complianceonline

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process for obtaining federal government approval for marketing new animal drug products that are under the jurisdiction of the FDA, and also briefly covers animal products that are regulated by other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture, and some flea and tick control products are regulated by the Environmental Protection Agency.

This three-day interactive seminar will provide attendees with an understanding of FDA’s veterinary drug approval process. The group size is small, generally between 8 and 20 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.

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, APHIS, NADA, FDA’s rules governing chemistry, animal field study, FDA compliant label, labeling, marketing, advertising, animal feed, veterinary devices, OTC drug products, FDA's product centers, Center for Food Safety and Applied Nutrition (CFSAN), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Tobacco Products, Center for Veterinary Medicine (CVM), environmental Impact (EA/CE), container Closure System, stability, Veterinary Clinical Trials, Animal Drug User Fees and Related Fee Waivers, 21 USC, 303 and 307

HubPlus Events

Pharmacy Career Conference is conceptualized for Pharmacy Students and Professionals who would like to explore the non-traditional pharmacy career options. The students and professionals who attend this conference would get an opportunity to meet industry stalwarts who will share their strategies and challenging stories in pursuing non-traditional pharmacy career options and learn on the current market trends and various opportunities within the sector. The conference would witness a series of interesting sessions by the industry leaders with an aim to help freshers to understand the dynamics and develop the skills to keep themselves ahead in the race. The initiative will bring together students from various pharmacy colleges and Industry Mentors along with the Hiring Managers from top companies to help the students to make right career choices. This platform helps students to clear all their queries and enables them to broaden their mind to make right choices for their future.

Attendee Enquiries;     Tél.: [+971 4 299 9398];     Email.: nina@hubplus-events.com

Pharmaceuticals, Pharma, Medicine, Medical, Career Development

Pharmacologie et développement des médicaments,    Formation médicale continue (FMC)