How to Conduct an Effective Annual Product Quality Review
Duration : 60 Minutes
Danielle DeLucy, Pharmaceuticals, Biotechnology
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, suc Read more
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.
Course Objectives:
• 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
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. If done properly, the Annual Product Review (APR) report can be a highly valued administrative tool by upper management.
Course Outline:
• Annual Product Review definitions
• Key benefits or purposes for effective APRs
• What needs to be included in the report
• Records and data
• Approaches for completing APRs
• Decision making based on APRs
• Regulatory expectations for Annual Product Reviews
• A model of an example Annual Product Review Report
• Review of citations
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This course is designed for professionals in the Pharmaceutical, Biotechnology and related industries who design, manufacture, organize or otherwise manage drug products and/or active pharmaceutical ingredients (API). It will be especially beneficial to individuals in the following areas:
• QA staff and management
• Compliance Personnel
• Regulatory Affairs
• Quality Assurance
• Product Submission
• Training
• Consultants
• Clinical Research
• Documentation and Technical Writing
• Project Management
• Product Development
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
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LIVE : Scheduled on
13-January-2025 :01:00 PM EST
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