GMP Compliance Toolkit

This product toolkit will guarantee regulatory compliance with FDA and global regulatory agencies. Consisting of two special editions, two pre-recorded webinars, and a specialized IVT conference compendium, this product collection covers GMP Training, investigations and inspections, documentation, quality agreements, HACCP, and utilizing statistics.




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Products in this Toolkit

| Product Code: VIDQ0007 | October 16, 2017 - 4:28 am PDT

Best Practices for Creating Quality Agreements

This webinar discusses the basic principles of a quality agreement, as well as the responsibilites, best practices, and FDA suggestions. Download the presentation here.

| Product Code: VIDQ0009 | November 9, 2012 - 7:12 am PST

Hazard Analysis and Critical Control Points (HACCP)

This pre-recorded webinar discusses the essential aspects and principles of Hazard Analysis and Critical Control Points (HACCP) including critical limits, monitoring, corrective action, and decision trees. Download the presentation here.

| Special Edition | Product Code: SPEQ0014 | January 8, 2013 - 2:50 pm PST

Roadmap to GMP Compliance Part I

Implementing the Tools of Process Quality — A Policy Statement Lynn TorbeckData Culture Lynn TorbeckAn Example of Absence of a Data Culture Lynn TorbeckUpsizing Compliance in a Downsizing Environment: Strategies for Ensuring GXP Compliance in the Face of Cost Reductions Eldon Henson

| Special Edition | Product Code: SPEQ0015 | January 18, 2013 - 12:28 pm PST

Roadmap to GMP Compliance Part II

Preparation, Preparation, and More Preparation Ballard Graham, Richard Poska, Robert Ertmann, and Paul L. PlutaIt’s All About Trust David MarkovitzImproved Utilization of Self-Inspection Programs within the GMP Environment–A Quality Risk Management Approach Barbara JeroncicGXP Compliance–Start with the Basics David MarkovitzFirst Impressions—The Plant Tour Paul L. PlutaFDA 483 Responses—Compliance Considerations Richard Poska and Ballard Graham

| Conference Compendium | Product Code: IVTQ6108 | November 15, 2016 - 12:00 am PST

Validation and GMP Week Puerto Rico 2016

Professionals Working in the GMP and Validation Environments met to:Understand FDA’s Quality Metrics Draft Guidance Learn how to use statistics in validationMaintain a robust cleaning and computer/software programsDevelop a Validation Master Plan (VMP) in critical environmentsConduct a gap analysis of your validation and GMP programs

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