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.
This webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changes in the FDA's CGMP audit "paradigm". Once recognizing the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.
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'.
Who Will Benefit:
This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Neutraceutical and Biologics fields. The employees who will benefit include:
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- Engineering
All personnel involved in a U.S. FDA-regulated environment. Especially those involved in the complain handling, non-conforming material, out-of-specification, failure investigations, root cause analysis, labeling, distribution, storage, tracking, and use or regulated medical products.
Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
