This FDA cGMP training webinar will discuss US FDA's approach to cGMP Audits and expectations from companies. It will also evaluate chief concern areas of cGMP compliance audit and anticipatory emphasis changes as per new regulatory climate.
Why Should You Attend :
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 headlines 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. 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.
Areas Covered in the Seminar :

• The "target".
• Avoid complacency from past "good" FDA audits.
• Avoid complacency from just completed "good" ISO audits.
• The desired response.
• How to respond now -- where to shift focus first.
• Where to direct scarce resources.
• A risk-based phased approach.
• Maintain 'the edge'.

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