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PDA Metro Chapter Pitfalls of Risk Assessment Dinner Meeting

Mar 13 - Mar 13, 2019
Basking Ridge, NJ

Join the PDA Metro Chapter to discuss real-world situations encountered during the execution of Quality Risk Assessments.

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Overview

Abstract

As the global regulatory landscape incorporates more and more requirements for risk assessments and risk-based approaches, the importance of quality risk management (QRM) continues to grow. QRM is also a hot topic at many regulatory inspections and agencies often actively review risk assessments in critical areas, e.g., cross-contamination. A solid QRM program and integration of QRM into the appropriate pharmaceutical quality systems help a company to be compliant, proactively identify risks to product quality before they become issues and reduce the number of manufacturing deviations. While building a robust QRM program and executing individual risk assessments, there are some common pitfalls teams come across that can lead to ineffective and inefficient QRM results.

This session will explore a variety of real-world situations encountered during the execution of quality risk assessments and their associated impact if they are not handled appropriately. This session will also cover solutions used in industry to prevent and/or course correct if these pitfalls present themselves.

Please submit questions to our speakers at pdametro@pda.org.

Agenda

    • 5:00 p.m. – 6:00 p.m. Registration Begins (Cash Bar, food, and Vendor Booths will open)
    • 6:00 p.m. – 7:00 p.m. Dinner
    • 7:00 p.m. – 8:30 p.m. Welcome, Seminar, Panel Q&A, and Closing Remarks

Highlighted Speakers

Stacey Largent
Stacey Largent
Merck

Travel

Please read: PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Olde Mill Inn Grain House

225 Route 202
Basking Ridge, NJ

Directions

Registration Fees

Regular Price

Registration Type Price by March 5
PDA Member $59
PDA Non-Member $74

Late Registration Price by March 6
PDA Member $99
PDA Non-Member $99
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