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Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed.
Why Should You Attend:
Batch record review is a GMP requirement. Furthermore, the trending of manufacturing data facilitates continuous product improvement, which is the focus of a pending ICH guidance document (ICH Q12). Pharmaceutical manufacturers will be expected to demonstrate that their manufacturing processes continue to produce medicinal products of consistently high quality.
Batch records can also be used to identify sources of manufacturing variability, enabling improvements to be made to the production method. This webinar details current regulatory expectations and sets out a logical approach for batch record review. Methods for trending batch data will also be discussed. In addition to understanding regulatory expectations, you will learn how to use batch records as tools to facilitate continuous improvement.
Areas Covered in the Webinar:
Frequently Asked Questions:
Who Will Benefit:
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.