Batch Record Design and Review - Webinar
The production batch record is one of the most important documents to demonstrate the compliance and the quality of a batch of pharmaceuticals. For this reason, it must be designed and reviewed from a scientific point of view. Rationales and procedures should be in place to manage the batch data. This webinar concentrates on the practical applications of GMP and FDA compliance requirements, from the batch record review process to final batch disposition. It begins with instructions and techniques for conducting a technical batch record review and identifying batch related discrepancies. The webinar 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).
- Event Type:
- Trade Show/Exhibition
- Sep. 26, 2019
Attendees will be provided with the technical knowledge and understanding of the compliance requirements along with “how-to” instructions for batch record review and follow-up investigtions. 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.
Attend this webinar to learn:
- GMP requirements for batch records
- Recommendations for reviewing batch records
- Variance/deviation/non-conformity systems
- Compliance requirements for follow-up investigations
- Evaluation of investigation findings
- Preparing the investigation report
Gilberto Dalmaso, PhD
Gilberto Dalmaso has over 25 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK). In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today Gilberto is the Global Life Science Scientific Officer for Particle Measuring Systems, serves on the European PDA Committee, is a reporter to numerous symposia on the microbiology and Pharma in Europe, Asia and United States, and is an ISO 9001 and HACCP quality system auditor.