Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes

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The FDA has specific ideas about risk management that affect areas of your manufacturing operations.

Without a good overview of the latest guidances, you may not know how to readily identify potential hazards, apply proper risk evaluation requirements or conduct pre- and post-market assessments of your drug products and medical devices.

Areas Covered

·         Assessing requirements for risk evaluation and mitigation strategies (REMS)

·         Format and content of a REMS submission

·         Using a drug master file for shared-system REMS submissions

·         Benefit-risk counseling of patients using a drug with a REMS

·         Determining how to develop a risk minimization action plan

·         Identifying how to conduct a health hazard evaluation

·         Evaluating pre-marketing risk

·         Meeting FDA-adopted international standards

·         ISO 10993 on biological evaluation of medical devices

·         ICH Q9 on quality risk management

·         ICH Q10 on pharmaceutical quality systems

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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