| GMP Annual Training GMP Update & FDA Regulatory Expectations Session 2 of 2 |
| Date: |
Thursday, March 18, 2010 |
| Time: |
8:20 am - 10:30 am |
| Description: |
This live and interactive two-session BenAstrum training will serve as a refresher course for those involved in the pharmaceutical and biotechnology arena. Highlights of the training will include the latest initiatives taken by Margaret Hamburg, M.D., the new Commissioner of Food and Drugs. The training will review the six systems the FDA use within their abbreviated and full inspection audits, and why they may choose one over the other. Validations will also be reviewed to include elements within the process, API, product, sterile product and cleaning of the total process/product equipment following use. In addition, an update on the Process Analytical Technology (PAT) initiative and its use within manufacturing will be provided, as well as an emphasis on Change control, its requirements and value. 21 CFR Part 11 and, in particular, the management of electronic data to include the use of Excel and Access spreadsheets will be reviewed and recommendations provided.
Warning Letters will also be used to illustrate some of the common repeated errors that companies encounter within 21 CFR Parts 210/211 and how incorrect responses may amplify their problems.
The objective of this extensive training is to explore GMP updates and FDA regulatory expectations, as well as assist in assuring that your organization is maintaining itself within a cGMP compliance framework.
LSAM Members to register or for further information call Norma (204) 272-5095 for special pricing including a generous discount from our training partner BenAstrum Training Center |
| PDF 1: |
GMPAnnualTraining-Mar9&18-2010.pdf |
