GMP Inspection Preparation Checklist: A Tool for Internal Auditing

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Would you like to make your next regulatory inspection less stressful? Don’t let your next inspection stress you out. This comprehensive webinar will help you with the tips investigators typically ask and it is the ultimate cheat sheet for your next inspection.

Areas covered

·   General questions for manufacturers of medicinal products and APIs — questions on sanitation, equipment, materials controls,              validation, documentation, change control and more

·   Manufacturing and testing of sterile products — questions on aseptic processes, sterilization methods and sterility testing

·    How GMP terms and ISO language can differ and how to reconcile them

·    The CFR and EU GMP references related to each quality requirement

·     How to conduct mock inspections

·     How using a GMP checklist can help you spot and fix problems before your next inspection


Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Deidre Tate,

Ms. Tate is a Project Director at Pinnacle Enterprise Group and has brought over two decades of experience in the design and execution of environmental, health, safety and regulatory compliance programs to Pinnacle. Prior to joining Pinnacle she enjoyed leadership roles at the corporate, divisional and facility levels. Specifically, Deidre has transformed underperforming safety cultures and environmental compliance programs for multinational companies within Automotive, Chemical, Oil & Gas and Pharmaceutical Manufacturing. Deidre is an experienced Process Safety Specialist and has conducted over 100 audits domestically and internationally as a lead auditor. She has also successfully implemented PSM/RMP, Responsible Care, VPP and CFATS at multiple facilities. Deidre served three consecutive appointments by the Dept. of Homeland Security to the U.S. Coast Guard Chemical Transportation Committee and two terms on the Board of Environmental Studies at Elon University. As part of the Pinnacle team, Deidre applies her EHS subject matter expertise to compliance auditing, program development and helping clients achieve ISO 14001, RC 14001 and VPP certifications. Deidre holds a B.S. from Michigan State University and has completed post graduate studies in the College of Chemical Engineering at Wayne State University.

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