FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.

This webinar will provide an overview of regulatory requirements for change control. It will focus on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc.

This training will provide an understanding of graphical tools used to identify multiple populations or failure modes. Attendees will learn how to estimate product reliability for multiple populations using Minitab® v17.

This Analytical Instrument Qualification training will guide you through Understanding of draft for analytical instrument qualification - Essential steps and recommendations for firmware and software validation.

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.

The Medical Device Classification webinar explains the classification system in US and the EU.

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 provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.

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 training on FDA supplier controls will help you refine your supplier chain management and vendor audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program.

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.

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.

Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.