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.
Products in this Toolkit
This webinar discusses the basic principles of a quality agreement, as well as the responsibilites, best practices, and FDA suggestions. Download the presentation here.
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.
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
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
Professionals Working in the GMP and Validation Environments met to:Understand FDA’s Quality Metrics Draft Guidance Learn how to use statistics in validationMaintain a robust cleaning and computer/software programsDevelop a Validation Master Plan (VMP) in critical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