Thursday, June 20, 2013 1- 3 p.m. EDT COST: Member: $195 Nonmember: $495 PRESENTERS: Marian Boardley, Marian Boardley Consulting Staci Eisner, Cortex Scientific Botanicals Stefan Gafner, Tom’s of Maine Anthony Young, Kleinfeld, Kaplan & Becker and AHPA General Counsel Who should attend: QA/QC personnel, Lab managers, technicians, Operations, R&D staff, New product development, and formulation personnel Register today! AHPA 8630 Fenton St., Ste. 918 Silver Spring, MD 20910 www.ahpa.org |
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| AHPA’s cGMP Compliance Series presents
“Best Practices” for cGMP Change Control cGMP compliance information for dietary supplement businesses Thursday, June 20, 2013 1 – 3 p.m. EDT Change control is the process of implementing changes to cGMP-related operations and other business systems in a manner that ensures effectiveness and continued compliance. Change control can be applied to any business system, but in a cGMP context it can be applied to: - Products (formulas, labels, etc.)
- Processes (manufacturing processes, test methods, etc.)
- Equipment and facilities (rooms, utility systems, process equipment, test equipment, instruments, utensils)
- Components and supplies, and vendors thereof
- Software, spreadsheets
- Personnel
- Documents (SOPs, MMRs, specification documents, forms, logs, etc.)
Some changes are routine, such as training new personnel, updating a document, or replacing a simple test instrument such as a thermometer; these changes can be controlled through the establishment of an SOP for each circumstance.
Other changes are not routine, such as installing new major manufacturing equipment or significantly changing a manufacturing process, and need to be evaluated on a case-by-case basis. During this two-hour teleseminar, which includes a dedicated Q&A session, learn from experts about how to implement and manage change control in compliance with 21 CFR 111. CLICK HERE TO REGISTER (or paste this link into your browser: https://connect.computility.com/form/index.php?id=bce42e4b4b2fd7dacf3eb6d1f3f8eff2 |
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