The Center for Professional Innovation & Education (CfPIE) Launches new Batch Record Review Training Course.
21 January 2008
The Center for Professional Innovation & Education (CfPIE) today introduced a new pharmaceutical training course targeted toward professionals responsible for Batch Records Review. The initial offering of Pharmaceutical Production Batch Record Review is scheduled for May 15 & 16, 2008 in Malvern, PA at the Desmond hotel & conference center.
This course is intended to give personnel working in a current Good Manufacturing Practices (cGMP) environment the tools necessary to face regulatory scrutiny of batch records and how to develop compliant programs. Efficient and effective batch record reviews provide pharmaceutical companies with two strategies. First, reviews are critical in maintaining control of a firm's operations, eliminating any guesswork and aiding in the resolution of atypical occurrences. Secondly, they enable a company to maintain and demonstrate a compliant posture - a sure way to avoid any quandary with the regulatory agencies.
"With ever-increasing regulatory oversight of product integrity, quality and manufacturing practices, proper batch record maintenance is of the utmost importance," said Bill Beyer, Director of Marketing for CfPIE. "Successful marketability of a drug is entirely reliant on efficient and compliant manufacturing practices, which includes the review of batch records. This course will give attendees a comprehensive skill set with which they can tackle batch record reviews with confidence."
Future offerings of this course will take place in Malvern, PA and Costa Mesa CA. Additionally, a customized version of this program can be offered at client sites anywhere in the world.
