ComplianceOnline

ComplianceOnline, the leading GRC advisory network, and well known regulatory affairs expert Dr. David Lim, will conduct a day long, interactive workshop on premarket 510(k) notification submissions for medical devices.

ComplianceOnline, the leading GRC advisory network, and leading quality systems advisor Dr. Richard Poser, will conduct a two day, in-person seminar on how to prepare for laboratory inspections and avoid Form 483 observations.

ComplianceOnline, the leading GRC advisory network, and well known regulatory affairs expert Dr. Mukesh Kumar, will conduct a two day, in-person seminar on the FDA’s GMP expectations for Phase 1 and first-in-man clinical trials.

This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations.

This 90-minute webinar will cover the best industry practices for Failure Modes and Effects Analysis (FMEA). You will learn what mistakes to avoid, how to reduce design and manufacturing defects, and how to implement risk management efficiently.

This 90-minute webinar covers all aspects of post market surveillance (PMS) for medical devices. It will direct you to the specific documents for the detailed information you need for an effective post-market surveillance system.

This 90-minute webinar will help you understand the competence and training requirements in the Quality Management Systems for medical devices, especially FDA QSR, ISO 13485, and even ISO 9001.

This 90 minute interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations.

This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.

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.