Jennifer Ahearn & Daniel Spankie will be presenting at the CHPA cGMP Workshop on November 12-13, 2018!
Sr. Managing Consultant and Practice Group Director Jennifer Ahearn and Sr. Consultant Daniel Spankie will be presenting at a Consumer Healthcare Products Association (CHPA) cGMP workshop on Monday, November 12th from 10:00 a.m. – 5:00 p.m. and Tuesday, November 13th from 8:30 a.m. – 12:30 p.m. The workshop, titled “Good Manufacturing Practices & Recent Inspection Findings for Human OTC Products” is open to all CHPA members and has an action-packed agenda, so spots are likely to fill up fast!
Laws, Regulations, and Monographs
Holding and Distribution
Organization & Personnel/Q10
Returned & Salvaged Drug Products
Buildings & Facilities
Records & Report
Control of Components & Drug
FDA’s Risk Based Approach to cGMPs
Production & Process Controls
FDA Inspection Trends
Packaging and Labeling Control
Current Good Manufacturing Practices (cGMP) are the FDA’s formal regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities. Pharmaceutical and biotechnology companies must follow cGMPs to ensure their products are manufactured to specific requirements including identity, strength, quality, and purity.
The “c” in cGMP serves to remind companies that they must employ up-to-date technologies and systems in order to comply with these regulations. What better way to stay abreast of the latest trends and developments than this workshop? If you or someone you know might be interested, visit https://chpa.org/OTCAcademy/cGMP_OTCs_101.aspx.