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Description: Compliance expert Gordon Richman clarifies the FDA’s Part 11 focus on electronic systems as part of GMP inspections and offers advice for preparing systems to pass muster. Richman discusses:
Background and development of the Part 11 regulations;
How the FDA’s 2010 Part 11 “Tag-Along” Inspections initiative was used to evaluate the industry’s understanding of and compliance with the regulations; and
Description: Jack Garvey, founder of Compliance Architects, interprets the FDA guidance “Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products,” discusses the agency’s intent in creating the guidance and identifies potential problem points, including:
Documenting substantiation for reduced activities to carry out an emergency plan;