Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

Attendees will come away from this training program with a good understanding of upcoming changes to the ISO standard and the implication of those changes to the classification and operation of clean rooms in regulated industries.

This training program will enumerate the inspection process for API, drug and device manufacturers and summarize recent changes. It will guide attendees on preparing staff for the new FDA inspections and discuss the role of exit meeting to avoid enforcement.

This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.

This medical device webinar will discuss strategies for meeting the Post Market Surveillance requirements as described in Annex X of the MDD (MDD 93/42/EEC, updated per the 2007/47/EEC M5 amendment, Annex 1: Essential Requirements), MEDDEV 2.7.1, Dec 2009 and ISO 14155.

This webinar will help you understand the rationale for Generic Drug Product Development via an ANDA Filing and the potential added value of a Paragraph IV Application, exclusive to the US market.

This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).

This discussion is geared for the pharmaceutical industry. It will provide pharmacovigilance (product safety) departments with solid ideas to help them prepare for and manage a health authority inspection. Medical information, research and development and quality and compliance groups in the pharmaceutical industry would benefit from tips discussed in this session as well.

This webinar on FDA acceptance of non-US clinical trials will discuss the current FDA requirements for using clinical data from non-IND/IDE clinical trials in support of an IND and/or marketing approval application.

This webinar will focus on the new requirements of EU Medical Device Directive Essential Requirements Checklist (ERC). It will also explain the relationship between ERC, Clinical Evaluation Report and Technical File.

This training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using case studies to highlight common deficiencies and potential solutions.

This training program will furnish attendees with an overview of the EU vigilance system and the understanding and tools necessary for effective QMS implementation. It will also provide an implementation checklist for the vigilance system.

This US FDA final guidance documentation training program will give an insider’s insight into the final guidance and discuss the rationale for such. The course will also elaborate CGMP statutory and regulatory requirements and recommendations for complying with the statue.

This webinar will discuss the disclosure requirements for clinical investigators under the Sunshine Act. It will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting.

This course will explore why auditing laboratories is the ideal tool to verify compliance of laboratory practices. It will guide attendees in preparing for FDA inspections, while detailing documentation requirements for the FDA and ISO.

This FDA GMP training will help you understand the current requirements for raw material management with tips for practical implementation. It covers FDA’s expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of material supplied, expectations from quality control and documentation processes, and training requirements, with case studies.

This webinar will discuss requirements and compliance under the applicable FDA regulations for medical device reporting (MDR), recall and reports of corrections and removals in the US. It is designed to help the audience develop, maintain and implement adequate procedures.

This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Attendees will also gain exposure to the elements and a methodology for global regulatory plan development and maintenance.

This training program will help industry better understand FDA regulations and its role in governing opioid medications. Among other key topics in the area, it will also discuss recent FDA approvals for opioid medications.

This medical device webinar will discuss the FDA guidance on Mobile Medical Applications and provide clarification on the primary points of the guidance.

This training program will prepare attendees for new regulatory requirements that will arise and apply to your cell line, even if it was made before the requirements were in place. One of the first steps in a recombinant project is the development of the cell line to produce the protein of interest, generally years before the product will be filed for licensure. How do you peer into the future to make sure that when the day comes to file for approval that you have collected and saved all the necessary information on that cell line and your master and working cell banks? Don’t make the mistake of assuming that you can find all that information years from now – create a plan to ensure everything is documented and saved.