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How to Conduct an Effective Annual Product Quality Review
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Instructor Profile:
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Description:
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. It will also discuss the comparative evaluation about similarities and differences of requirements associated with the manufacturing of the drug product in different countries. It is also necessary to know that the regulatory requirements of different countries are different and hence this will further guarantee the quality of the pharmaceutical product.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Objectives of the Presentation:
Discuss how to write APRsOutline the requirements for APR reportingReview what information to include in the reportsDiscuss how well written APRs benefit your firm's compliance.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Areas Covered:
Annual Product Review definitionsKey benefits or purposes for effective APRsWhat needs to be included in the reportRecords and dataApproaches for completing APRsDecision making based on APRsRegulatory expectations for Annual Product ReviewsA model of an example Annual Product Review ReportReview of citations.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Who can Benefit:
• QA staff and management• Compliance Personnel• Regulatory Affairs• Quality Assurance• Product Submission• Training• Consultants• Clinical Research.etc..
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Effective Annual Product Quality Review
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
