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Live Webinar on
Equipment Requalification: What and When is Really Required? Date: Thursday, June 26, 2014 Duration:
60 Minutes
Location:
Online
Instructor:
Time: 10:00 AM PDT | 01:00 PM EDT
Register Now
Jennifer Medlar
Overview: The process of setting up equipment in a facility that manufactures FDA regulated products includes ensuring that the equipment will safely and consistently work as intended. To cover all of the necessary criteria, equipment qualifications are typically organized by separating the protocol into three sections, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
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Sustainable approach for addressing requalification The importance of traceability and clarity in demonstrating compliance How change control and other quality programs feed into the equipment qualification program Audit forms/checklists and other equipment requalification documents Identification of events that could trigger requalification Using a risk-based evaluation to determine the extent of the requalification Common pitfalls to avoid when requalifying equipment
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Internal Auditors Regulators Compliance Officers QC Managers QA Managers Quality and Validation Department Staff Compliance Consultants Senior Management Medical Device, Pharmaceutical, Biopharmaceutical Manufacturers
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About Speaker Jennifer Medlar Quality Operations Manager, Advanced Biomedical Consulting (ABC), LLC Jennifer Medlar a Quality Operations Manager at Advanced Biomedical Consulting (ABC), LLC, has experience in the areas of quality assurance, quality control, process development, and validation in both industry and consulting roles. She has experience in the biopharmaceutical, pharmaceutical, medical device, cosmetic, dietary supplement, industrial product, and education industries.
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