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

This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.

This webinar will help Sponsors, CROs and study sites running clinical trials in the EU and internationally; understand the important, updated compliance requirements concerning the new EU Clinical Trials Regulation due to be enacted in 2016 and which will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC).

This clinical research compliance training will explain in detail the list of required regulatory documentation for clinical trials for industries such as pharmaceutical, biotechnology, medical devices and diagnostics. It will also review many of the documents in terms of required content and structure.

This FDA New Drug Approval process training will provide attendees with the knowledge and skills needed to develop a successful 505 (b)(2) program.

This training will give attendees an insight into the interpretation of GCP regulations by the European Medicines Agency (EMA) as they relate to the management of trial documents, focusing especially on clarification within the paper on disputed and ambiguous areas of trial master file (TMF) management.

The webinar will discuss the do’s and don’ts for using social media in marketing FDA-regulated products. Common issues, misconceptions, perceptions, and possible solutions will be discussed. The presentation will to familiarize you with the current FDA rules and help you plan for developments expected in the near future.

This webinar will provide a comprehensive overview of FDA regulations for cosmetic products. It will help you understand how to be compliant in manufacturing, labeling and advertising of cosmetic products, and thereby ensure successful FDA and state inspections.

This GLP compliant assay training will help attendees deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.

This 3-hour training will review and compare FDA’s Establishment Registration and Product Listing Requirements; and available User Fees, Fee Waivers and Marketing Exclusivity for Drugs, Biologics, Medical Devices, Food, Tobacco and Animal Health Products.

This webinar will provide an in-depth understanding of California specific laws, affecting food and other product manufacturers and marketers, such as the Prop 65, the Green Chemistry Initiative, and the Rigid Plastic Packaging Act. We will discuss these laws, how to comply with them and avoid litigation.

This webinar on drug price reporting will discuss the changes to the Medicaid Drug Program and its impact on pharmaceutical and biotech companies.

This 3 hour virtual seminar will help you create an integrated medical device software development process that will meet IEC 62304 and ISO 13485 design control requirements, and generate the documentation needed for software as part of a FDA submission.

This webinar will cover regulatory requirements for archiving clinical trial documents, both paper and electronic records. It will focus on the key components of a digital preservation strategy to ensure the ongoing retrievability and accessibility of clinical trial electronic records.

The webinar will familiarize participants with the FDA's Refuse to Accept Policy for medical device 510(k)’s and help you ensure that your 510(k) application is not rejected for lack of administrative completeness.

The webinar will discuss best QC practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.

This FDA software validation Webinar/training will discuss how to self audit and ensure validation and software quality processes that will pass FDA inspection.

This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA.

This webinar will provide an introduction to the FDA’s regulation of Over-the-Counter (OTC) drug products and the various methods for bringing such a product to market. You will learn the various options for marketing an OTC drug, gain an understanding of FDA’s relevant labeling and promotional rules, and learn strategies for mitigating the potential risk for FDA regulatory enforcement.

This training on medical foods will provide an introduction to FDA’s regulation of medical products, assist you in identifying when it may be appropriate to market a product as a medical food; recommend strategies for marketing such products; and summarize recent FDA enforcement actions in the area to help companies mitigate the risk of potential Agency enforcement action.

This training on legal writing for regulatory submissions will provide practical tips that have proven to enhance the persuasiveness of regulatory submissions and help you succeed even if some of your test results or other supporting information are lacking.