Konferenzen  >  Medizin & Gesundheitswesen  >  Legislation in der Medizin und Pharmakologie

ComplianceOnline

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations. In this course you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training. To accomplish these goals, we will review regulatory agency expectations when an SOP is written, provide suggestions for uncovering the process in its entirety and describe it clearly and concisely, indicate how to break portions of the process(es) into logical chunks, and show how the SOP and the training program can work together harmoniously.

Improve the writing of SOPs for more effective training and reduction of errors and to understand the regulatory implications of what is written in an SOP, learn the parameters of an effective SOP, explore the connection between SOPs and job performance, and measure retention of SOP content at the training stage

ComplianceOnline

US FDA statements and actions indicate the initial and purpose of Part 11 "Add-on" inspections are being extended beyond what was to be a short term review of industry's response to Part 11. Using the field tested techniques presented in this webinar, an internal and/or supplier audit can provide much the same early warnings as a real FDA compliance CGMP audit. This webinar will provide test scripts and rationale for a "model" for company internal and supplier audits.

Event Manager;     Tel.: [+1-888-717-2436];     Email: sshastry@complianceonline.com

Audits for CGMP Compliance, Old QSR, New QMSR, Combo Products, Pharma and Dietary Supplements, Internal and Supplier Audits, Virtual Audits, Layered Process Audits, ISO 13485, ICH Q7, ISO 9001 GMP, QMS, CAPA Requirements, Root Cause Analysis Tools, Six Sigma, Problem Solving Tools, Methodology, FDA Requirements, Management Responsibility

ComplianceOnline

Reduce costs, usually by two-thirds, for compliance with electronic records, Learn how to use electronic records and electronic signatures to maximize productivity, Avoid 483 and Warning Letters, Understand your responsibilities and liabilities when using SaaS/cloud, Learn how to buy COTS software and qualify vendors

Event Manager;     Tel.: [+1-888-717-2436];     Email: sshastry@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

Virtue Insight

The 8th Annual Pharma Regulatory Summit 2025 brings together leading global pharmaceutical industry professionals and regulators to exchange insights on cutting-edge technologies, strategies, and solutions that drive innovation and uphold quality in medicines delivered to patients worldwide. This interactive forum features expert-led presentations and discussions, creating an ideal platform for professionals to explore and implement innovative solutions tailored to the evolving regulatory landscape of India’s pharmaceutical industry.

Kavitha;     Tel.: [9361957193];     Email: Kavitha@virtueinsight.co.in

Regulatory Affairs, Regulatory Writing, Medical Writing, Publishing, Submissions, scientific writing

FDAMap

Clinical trials are highly regulated multi-dimensional projects that require constant interactions between the regulators and the sponsors, investigators, other personnel, and even patients involved in the conduct of a given trial. There are many diverse tasks involved in the conduct of a clinical trial starting from the development of a clinical trial protocol, finding and starting clinical trial sites, filing of an IND or IDE application, approvals from IRBs, numerous documents need to be collected to demonstrate compliance with regulations; managing supplies, collecting data, writing reports, and many other things. Clinical project managers need to understand, implement, and trouble-shoot practically all aspects of the clinical trial under them. Clinical project managers have to build teams and have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. This one-of-a-kind program will train you in regulatory affairs, clinical operations, monitoring, patient recruitment and retention, planning, medical writing, safety monitoring and practically all major aspects of running a clinical trial.

Clinical Project Management, Clinical Project Managers, FDA Regulations, FDA Compliance,

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

ComplianceOnline

This 3 hour webinar is focused on understanding the Medical Device Single Audit Program, the scope of the program, how to apply, the Authorized Organizations, the rating system developed and what you can expect when signing onto the program. The webinar will discuss how such audits are organized, what to expect during a MDSAP audit, how does this differ from a typical certified body audit, along with document movement and timeline expectations in receiving the facility’s certificate.

Event Manager;     Tel.: [+1-888-717-2436];     Email: sshastry@complianceonline.com

The Medical Device Single Audit Program (MDSAP), 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

The program will explain how to determine the needed elements of a quality management system, how to decide which procedures are necessary, and how to configure the system for future growth. The program will also cover the FDA inspection process, and introduce participants to key FDA documents that explain the process in detail and facilitate effective preparation and management of FDA inspections.

Event Manager;     Tel.: [+1-888-717-2436];     Email: sshastry@complianceonline.com

Introduction to FDA law, regulation and GXP Concepts, Fundamentals of Good Manufacturing Practice, Data Integrity: What it is and why it is important to GMP, Building a GXP Quality Management System, Selection qualification and monitoring of contractors, Phase appropriate GMP considerations – investigational drugs vs commercial, Preparing for and Managing FDA Inspections, Enforcement considerations

FDAMap

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

Sop, Quality Management System, FDA Regulation, FDA Compliance

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

FDAMap

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

Sop, Quality Management System, FDA Regulation, FDA Compliance

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

ComplianceOnline

This seminar will help all personnel responsible for CMO oversight understand how to ensure effective quality oversight of CMOs- from start to finish. In-depth focus will be placed on Selection and Qualification, CMO Audits, Quality Agreements, Oversight of CMO Operations, and Review of Key CMO Records. Considerations for different types of manufacturing will be highlighted, and techniques for managing difficult CMO situations will be addressed. Techniques for assuring robust CMO Oversight programs in light of COVID-19 restrictions will also be discussed.

Event Manager;     Tel.: [+1-888-717-2436];     Email: sshastry@complianceonline.com

pharmaceutical contract laboratories, pharmaceutical contract manufacturers in usa, contract drug manufacturers, pharmaceutical contract companies, contract drug manufacturing companies, pharma contract manufacturers, pharmaceutical contract manufacturing companies, outsourcing in pharmaceutical industry, american pharmaceutical outsourcing, pharmaceutical manufacturing industry, pharmaceutical outsourcing trends, pharmaceutical outsourcing companies, pharmaceutical manufacturing process, pharmaceutical contract manufacturing services, CMO Oversight in Pharma Industry, CMO compliance, CMO business model, CMO Qualification Audit, CMO operations, CMO records, CMO situations, CMO audits

FDAMap

The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others.

Technical Writing, Regulatory Writing, FDA Regulations, FDA compliance

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

FDAMap

The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others.

Technical Writing, Regulatory Writing, FDA Regulations, FDA compliance

Pharmakologie und Arzneimittelentwicklung,    Translationale Medizin, Klinische Studien

CHI

The Bio-IT World Conference & Expo is the premier global event showcasing the technologies and analytic approaches that solve problems, accelerate science, and drive the future of precision medicine. From April 2-4, 2025, our 24th annual gathering will bring together global experts in the fields of biomedical research, drug discovery & development, and healthcare to explore cutting-edge innovations and best practice applications. Conversations here will connect you with the people, ideas, and opportunities you need to build your business and advance your research. The program offers inspiring plenary keynotes, over 200 educational and technical presentations, three days of networking opportunities, and an exhibit hall featuring leading technology and scientific solutions providers.

Tel.: [781.972.5400];     Email: chi@healthtech.com

ComplianceOnline

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in each country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping. These requirements include the required education, training and experience for employees whose activities affect the quality of drug products. Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training.

Event Manager;     Tel.: [+1-888-717-2436];     Email: sshastry@complianceonline.com

Good Manufacturing Practices, GMP, pharmaceutical production, cGMP, GMP training, GMP compliance, US FDA regulations, drug manufacturing laws, GMP laws, pharmaceutical industry, GMP education, pharmaceutical compliance, GMP training seminar, noncompliance consequences, GMP enforcement

Magnus Group

Prepare to immerse yourself in the 5th Edition of the International Vaccines Congress (IVC 2025), taking place from October 23-25, 2025, in the vibrant city of Orlando, Florida, USA! This highly anticipated International Vaccines Congress 2025 will offer a unique hybrid format, seamlessly blending onsite and online experiences to maximize global reach and participation. Dive deep into the latest advancements and transformative trends in vaccine science under the theme: From Discovery to Distribution: The Path of Vaccines.

Tel.: [17029882320];     Email: vaccines@magnusconference.com