As Dan Fabricant, Director of the FDA’s Dietary Supplements Program, states in recent communications with Industry, he views the level of non-compliance of dietary supplement manufactures with cGMP’s (current good manufacturing practices) as astonishing. Based on audits that have been completed by the FDA’s compliance division they have estimated that nearly 70% of dietary supplement manufacturers are currently not up …
Is your Company Compliant? Learn More at our “Best Practices” Webinar
“Best Practices” for post-market surveillance & regulatory reporting of dietary supplement and OTC drug adverse events.
Although “Best Practice” AE Processes can be fairly straightforward, there are a variety of challenges a manufacturer must overcome when implementing an AE system. These can include designing a database, developing SOP’s for managing, documenting, analyzing and reporting indicated events, and overcoming internal …
Dr. Rick Kingston to Present at CHPA’s Regulatory and Scientific Conference
Best Practices in Safety Surveillance
The Landscape of Post-Market Surveillance for Consumer Health Care Products
Thursday, May 10th, 2011
3:15 – 4:00 pm EST
Dr. Rick Kingston, president of regulatory and scientific affairs at SafetyCall International, PLLC, will be presenting at the Consumer Healthcare Products Association’s Regulatory and Scientific Conference. His lecture will discuss how the regulatory and pharmacovigilance environment …