FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training will provide a practical methodology for creating and applying Risk-Based Equipment Validation. It will show an example of how this process may be integrated into a facility Master Validation Plan.

This webinar on clinical trial audit/ inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them.

This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.

This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation.

This webinar on IND and IDE Application management will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial.

This webinar on product complaint investigations will provide the necessary information to those in food, drug, device, cosmetic and related industries that manufacture and distribute products to consumers on how to best receive, respond, investigate and correct product complaints in the best interests of the firm.

This 90-minute webinar on Lean Project Management for U.S. FDA Regulated companies will show how you can incorporate basic lean principles for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale, while addressing FDA / CGMP requirements.

This 21CFR Part 11 training will clarify the relationship between predicate rules and 21 CFR part 11 compliance, allowing companies to satisfy FDA with a minimum of effort.

This 90-minute webinar will provide guidelines for bioassay validation and regulatory documentation, the steps for technology transfer and commercial validation show how to implement the new USP chapters 1032, 1033 and 1034.

This 90-minute webinar will review FDA expectations/ requirements for discussing off label uses of medical products on social media, e.g.,Twitter®, Facebook®, etc. We will also discuss key elements of the FDA's new Draft Guidance, "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices", Dec 2011.

This webinar on Good Documentation Practices will review the FDA requirements for documenting data in preclinical and clinical studies and manufacturing activities.

This Webinar will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial.

This Bioassays webinar will systematically outline the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.

This webinar on SOPs will instruct you in creating, managing and implementing adequate SOPs that can impress even the FDA inspectors.

This 3-hr virtual seminar on the Electronic Common Technical Document will help you understand the background, technical aspects, document structure, and use of the electronic Common Technical Document.

This webinar on Potency Bioassays will show how to implement the parameters described in the new USP Bioassay suite to deliver compliant assays for Phase I/II, Phase III and commercial products.

This FDA Good Documentation Practices training will introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.

This 5-hr GMP requirements training for Combination Products will help you understand FDA's draft guidance on GMPs for Combination Products and provide practical solutions and tools for revamping your quality system to meet this new paradigm.

This 4-hr virtual seminar will focus on Japan's overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. It will cover topics relating to pre-clinical and clinical requirements and address the structure of the regulatory agencies in Japan.

This FDA Pre-Approval Inspection training will focus on the purpose and scope of pre-approval inspections, the consequences from them, and keys to a successful FDA pre-approval inspection.