FDA Compliance Training & Regulations

Analytical Test Methods Validation: FDA, ICH and USP Requirements CD

This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation. Learn more

Practical Process Validations - Pack of Two Courses CD

Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated. Learn more

Design History Files and Technical Files under US FDA and EU MDD CD

This medical device compliance training will be helped to see how to understand the similarities and differences of these two complimentary documents and how to comply with the respective requirements and develop compliant files to address. Learn more

Practical Aspects of Aseptic Processing CD

This FDA compliance training will describe the essential requirements for producing sterile products in a practical, clear, concise manner that will facilitate its implementation. Learn more

21 CFR Part 11 compliance under the Obama administration CD

This 21 CFR Part 11 training will deliver concrete guidance which will provide a roadmap for compliance that will have immediate benefits, withstand FDA’s changes to Part 11, and discuss the new Obama administration approach to enforcement. Learn more

Excel Spreadsheets-Step By Step Instructions for Compliance CD

Learn how to create an Excel spreadsheet application that is GxP compliant. Follow along as we configure Excel. This session will make you a better Excel user, saving you time and costs. Understand how to validate your application with minimal documentation. Learn more

Software Verification and Validation For FDA-Regulated Industries CD

This FDA compliance training will guide you through Software Verification and Validation process in FDA-Regulated Industries. Learn more

Meeting FDA Requirements for Over-the-Counter / OTC Drug Labeling CD

This FDA compliance training will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales. Learn more

FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes CD

This training will provide a solid understanding of FDA Requirements for Device Labeling. Attendees will gain comprehensive knowledge on creation, approval and control of labels and labeling. Learn more

21 CFR Part 11 compliance for Electronic Medical Records CD

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

Validation and Use of Excel Spreadsheets in Regulated Environments CD

This excel validation training/ webinar will demonstrate how to design spreadsheets for part 11/GxP /SOX/HIPAA, document planning, specifications, installation, testing and changes to meet FDA requirements. Learn more

New Medical Device Vigilance Guidelines CD

This Medical device training will provide valuable assistance and guidance to all medical device companies and user facilities involved in medical device vigilance Learn more

The 510(k) Submission: Requirements, Contents, and Options CD

This 510 (k) training webinar will discuss the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Learn more

Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices CD

This OnDemand Web Seminar is also Available on CD

This medical device training will include a discussion on what constitutes valid scientific evidence to support advertising and promotional claims, a review of relevant Warning Letters to better understand FDA’s policies regarding comparisons to competitor products and what constitutes off-label use. Learn more

Bringing Compliance to Design Control for Older Products CD

This Medical device training will provide valuable assistance and give a procedure to all regulated companies that need to bring their product design history files up to date with the new standards. Learn more

Validation Planning to Meet US FDA and ISO 13485 Requirements CD

This FDA validation training will guide you through the validation planning which required meeting the US FDA & ISO 13485 Requirements Learn more

Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. Learn more