This course concentrates on the practical applications of GMP and FDA compliance requirements, from the batch record review process to final batch disposition.
It begins with practical instructions and techniques for conducting a technical batch record review and identifying batch related discrepancies. The course then shifts to the follow-up investigation of discrepancies noted from batch production and testing and the decision making process for the final disposition of the batch (i.e., release, reject or rework).
The course lecture provides the attendees with technical knowledge and understanding of the compliance requirements, and “how-to” instructions for batch record review and follow-up investigations. This is achieved by focusing on the interpretation of the GMPs and FDA requirements, using FDA references, industry practices, FDA- 483 citations and “real-life” experiences. The knowledge acquired from the lecture is, then, applied to class workshops to enhance the practical skills for conducting batch record reviews, identifying significant discrepancies, conducting the necessary follow-up investigations and making the appropriate decision for batch disposition.
All topics and workshops in this course include examples for sterile and non-sterile products.
This course will teach the attendees how to perform a technical review of batch records to detect hidden compliance and quality problems. They will also acquire the skills to conduct the appropriate follow-up investigation and make the final decision or recommendations.
This course is intended for Production, Quality Assurance and Compliance personnel who are responsible for making batch record entries and performing reviews and compliance investigations. This course is suitable for both entry-level batch record reviewers and compliance personnel, as well as advanced-level personnel, including supervisors and managers.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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