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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;
Description: Is the FDA about to name you their fraud police? A proposed new rule will require sponsors to report data falsifications … without any proof … without a possible motive … and even if there’s only a suspicion of fraud. The FDA sent shockwaves through the industry on Feb. 19 when it announced a proposed rule called “Reporting Information Regarding Falsification of Data.” The rule will require sponsors to report any information that indicates that a person has, or may have, engaged in the falsification of data involving clinical investigations, nonclinical laboratory studies and clinical studies in animals. What exactly is going on here? Is the FDA trying to turn sponsors into detective, judge and jury? Learn more about this controversial proposal in this presentation.
Description: Regulatory specialist Gina Ross shows how to create a content development and organization strategy for developing electronic Common Technical Documents and how to develop authoring SOPs that ensure global compliance. Ross discusses:
How to train staff to write eCTDs;
Managing the document throughout its lifecycle; and
The decision-making process for most effective integration of regulatory strategies and eCTD lifecycle management