Center for Professional Innovation & Education, Inc., Malvern, PA
Mar. 10 & 11, 2014
Efficient and effective batch record reviews provide pharmaceutical companies with two strategies. First, reviews are key to maintaining control of your firm’s operations, eliminating any guesswork and aiding in the resolution of atypical occurrences. Secondly, they enable a company to maintain and demonstrate a compliant posture - a sure way to avoid any quandary with the regulatory agencies. This course is intended to take the mystery out of the batch record review process. The class examines the FDA and EU regulatory requirements for documentation and batch record reviews, explains the elements of the batch record review process, and clarifies the pathway to effective deviation investigations. Interactive sessions are included for identifying reviewer responsibilities, establishing good documentation practices, and writing procedures for the review process. Additionally, participants will be able to analyze their company’s compliance with these requirements and identify missing elements of the batch review process. Ample time is provided to address specific problems and questions of individual participants. Additional benefits of this class include: - Learn not just from the director, but tap into the knowledge of your peers: Participants will have the opportunity to anonymously submit their challenges, problems, and issues for classroom discussion
- Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 25 years of industry experience
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
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