Most Regulatory Agencies require firms to have written procedures in
place to document production and process controls, better known as batch
records. Additionally, there must be written procedures for a batch
record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
This webinar will analyze each of these necessary elements of the batch record review process.
I. Regulatory Requirements for GMP Documents – Batch Records and Beyond
II. Methods for Batch Record Review
III. Methods for Data Review and Actions taken for Deviations