In 2014, nearly 10% of 483 observations by the FDA stemmed from issues with Master Batch Records. Improving Master Batch Records can reduce 483 letters, make completing your batch records easier and ultimately improve the quality of your product.
In this webinar, regulatory experts share real incidents that illustrate common issues with Master Records and how to solve them. Other topics covered include:
- Master Batch Record vs. Batch Production Record
- Creating a Master Batch Record
- What the FDA looks for in a Master Batch Record
- Master Batch Record Checklist
- Capturing your Manufacturing Process
The webinar will last about an hour, with time available for questions. This is a great opportunity to gain valuable insight from compliance experts. The InstantGMP team has over 40 years of experience with FDA regulations and Good Manufacturing Practices. Marian Boardley is an Independent Consultant who manages compliance projects for dietary supplement manufacturers and distributors.