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.
Who Should Attend
This two-day course is designed for pharmaceutical production, quality assurance and compliance personnel who are responsible for the review and audit of production batch records, and batch record deviation investigations. This includes, but is not limited to, such positions in Quality Control, Quality Assurance, Manufacturing, and Packaging groups. Those who supervise, manage, or oversee these activities would also benefit from this program.
Upon completion of this course, attendees will gain a clear understanding of the batch record review expectations of regulatory agencies and discover the elements of an effective batch record reviewer training program. Participants will learn how to prepare for a technical review of batch records, as well as how to measure the effectiveness of the review process. In addition to recognizing what to do when a batch fails to meet specifications (deviations), how to determine deviation cause, and corrective and preventive action(s) (CAPA), learners will see the benefits of a working relationship between production and quality reviewers.
Frequently Asked Questions
How much coverage is given to the documentation of errors during a batch record review?
The material covers both the 21CFR and the Eudralex Vol. 4 content regarding the activities surrounding the batch record review including but not limited to reviewing all production batch records and making sure that all production deviations are reported and evaluated. Most often, class participants share their techniques for handling errors In addition to the instructor reviewing the handling of errors.
My company is using electronic batch record - are EBRs covered in the class?
The creation of EBRs and their relationship to an electronic manufacturing environment are presented, as well as a comparison to paper batch records.
Our batch record reviewers are struggling with the technique of reviewing a record. Does the class present "how" to review a batch record?
In fact, the instructor presents a "best practice" for reviewing batch records and participants actually practice reviewing a record as one of the class exercises.