Process knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each critical step of the process operation and the overall process results based on statistical database for each batch of that product code.
Why should you Attend:
To gain a current comprehension of the new PV Guidelines and the determination of how to do the required Statistical Monitoring and Data Analysis to prove the process is consistent and to avoid situations that could cause 483s, Warning Letters and Consent Decrees as well as gaining the capability of avoiding rework and recall expenses.
Areas Covered in the Session:
Process knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each unit operation and the process overall.
Who Will Benefit:
Product and Process Development
Jerry Dalfors has extensive (40 years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages.
Compliance4All DBA NetZealous,