FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar examines the issues in audit sampling and provides the answers one need to plan audit. It will help attendees understand the use of standard sampling plans in an audit including FDA’s QSIT sampling plans.

This webinar on addressing fungal and bacterial spore outbreaks will discuss case studies on excursion investigations and show how facility design, personnel practices and cleaning and disinfection effect excursion investigations.

This webinar will teach you what is expected under the new requirements of the Food Safety Modernization Act. Every food company that manufactures or supplies food under FDA jurisdiction is now or will be required to have a Foreign Supplier Verification Program in place.

This webinar will explain how to create, develop and manage Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods.

This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., “existing devices”) during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).

Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

This webinar will discuss the requirements for handling deviation based on GMPs, ICH guidance documents and other relevant guidance. It will also explain ICH Q8, Q9, and Q10 guidance documents and will provide best practices to ensure compliance with these documents in regards to handling deviations and nonconforming products.

This Virtual Boot Camp will provide an overview of the FDA inspection program, how to prepare for an inspection of your facility and the FDA program that applies to foreign food facility inspections.

This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.

This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.

This webinar will focus on the effective crisis communication strategies. Attendees will learn best practices to protect their organization’s brand in the time of crisis.

This webinar will focus on the specific types of writing responsibilities available in industry. It will help attendees understand the medical writing profession and in determining if medical writing or technical writing is a good fit for each of them.

This training program will provide an overview of 21 CFR 111 regulatory requirements which governs how dietary supplements are manufactured and tested. It will futher review the test procedures and documentation requirements to ensure regulatory compliance.

This webinar will discuss the details of specific excursion investigation for outbreaks of molds, vegetative bacteria, and Bacillus.

This webinar will cover US FDA and Customs legal import requirements including discussion on FDA product codes, Custom's Harmonized Tariff Schedule (HTS) and Affirmation of Compliance (AOC). It will also provide information on FDA's software screening program, PREDICT, and U.S. Custom's ACE program.

This webinar will provide valuable assistance to all regulated companies; a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

This webinar will focus on most trustworthy open access resources. It will also provide tips on how to gain access to hard-to-find materials by paying high subscription or membership fees.

This webinar explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations.

This webinar will cover basics of process validation along with current industry practices. It will also discuss recent FDA draft guidance document and the importance of good process validation.