Preparation for GMP Inspections by Regulatory Agencies - 2017
- Start Date:
- Wednesday, 5 April, 2017
- End Date:
- Wednesday, 5 April, 2017 12:30pm
- Health & Nutrition
Overview: This webinar will provide practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible, including ongoing readiness for inspections, rehearsals and preparation for successful facility inspections, and response to findings by regulatory agencies. Why should you Attend:Good manufacturing practice (GMP) is the minimum standard that a manufacturer must meet in their production processes.This webinar will review what to expect during the Agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.
Areas Covered in the Session:Types of Inspections (for cause, pre-approval, periodic ) > API & FDFNotification TimingForeign FacilitiesWhat to expect during InspectionDo a company audit as the FDA would (fall dress rehearsal)Make adjustments as needed/address issues/take needed actionsManaging the InspectionInspection on follow-up Who Will Benefit:Design EngineersManufacturingSupply chainTechnical operationsQuality controlQuality assuranceRegulatory affairs Speaker Profile: Peggy J.
Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
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