Proper Execution of Annual Product Reviews
Instructor:
Danielle DeLucy
Product ID: 704993
- Duration: 60 Min
Why Should You Attend:
Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize the product defects and also the risks associated with the manufacturing of the pharmaceutical product.
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.
Learning Objectives:
This webinar will review:
- Annual Product Review definition
- What needs to be included in the report
- A model of an example Annual Product Review Report
- Review of citations
Areas Covered in the Webinar:
- Discuss how to write APRs
- Outline the requirements for APR reporting
- Review what information to include in the reports
- Discuss how well written APRs benefit your firm’s compliance
Who Will Benefit:
- Site Quality Operations Managers
- Quality Assurance personnel
- Plant Managers and Supervisors
- Manufacturing Superintendents and Managers
- Regulatory Affairs Managers
Danielle DeLucy
Owner, ASA Training and Consulting, LLC
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.
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Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
