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Meet the Tougher U.S. FDA CGMPs
This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.
Why Should You Attend:
There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.
The Agency has come under increasing negative publicity due to major, high profile drug and device problems / recalls, and public concerns over insufficient FDA oversight of new product introductions. In an effort to counter this public perception, FDA's audits have changed and have become less forgiving.
Businesses continue to "shoot themselves in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do some of their work for them. And they're "piercing the corporate veil" to prosecute senior management involved in lying or fraud. There will be no return to the past.
During this session, 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. Attending this training will enhance your awareness and provide you the understanding necessary to modify internal audits to match this FDA shift. Upon completion of this training, you will be in a position to evaluate your existing compliance and internal audit emphasis in light of the changes in the FDA's CGMP audit "paradigm", identify gaps and then put in place the necessary fixes to ensure continuing compliance.
Areas Covered in the Webinar:
- The "targets".
- Avoid complacency from past "good" U.S. FDA/ EU ISO audits.
- The basic underlying issues
- Proactive responses -- where to shift focus first
- Where to direct scarce resources
- A risk-based phased approach
- Avoid 'entropy' -- Prove 'in control'
- Maintain 'the edge'
Who Will Benefit:
This training will benefit personnel/ companies in the pharmaceutical, medical device, diagnostic, nutraceuticals and biologics fields. The employees who will benefit include:
- Senior management
- Regulatory Affairs
- Quality Assurance
- Internal Audit
- All personnel involved in a U.S. FDA-regulated environment, especially those involved in regulatory compliance, CGMP training and auditing, and the production and documentation of regulated medical products.
John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln 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 software validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln 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. Mr. Lincoln is a graduate of UCLA.
Topic Back Ground:
The FDA says it's getting tougher. Recent events indicate that's true. Recent audits indicate the past ways of doing things is not acceptable. There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and recent public concern over insufficient oversight of new product introductions (and grandfathered product) by means of the 510(k) system. "Business as usual" is unacceptable. Business continues to "shoot itself in the foot", including once highly respected model companies have fallen flat or worse . All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. There will be no return to the past. Each company should try to revisit their strategy of internal audit and enhance the key processes so that they can match it against the FDA’s shift in the requirements.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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John E Lincoln
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