Prepare for Tougher U.S. FDA cGMP Compliance Audits - Webinar By ComplianceOnline (FDA Compliance)
|Event Date/Time: Feb 07, 2012||End Date/Time: Feb 07, 2012|
Recent audits indicate the past ways of doing things will no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. Recent events in regulated industries indicate a public's growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA.
How this is affecting the Agency's approach to audits and their expectations for companies. Pressure on the 510(k) process is only one example. They also use GMP compliance audits to drive companies to do much of their work for them. How they drive companies to do much of their work for them. We will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate.