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.
And business continues to 'shoot itself 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 much of their work for them. Failure to anticipate, find and correct compliance problems before an FDA site inspection can result in unnecessary 483 Observations, possible Warning Letters, or worst, and a competitive “hit” in the marketplace - all preventable by the effective internal CGMP compliance audit/inspection.
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. This information will be used to add to the FDA’s inspection “model”, to provide a field-tested approach to a company’s internal audit program. QSIT for medical devices and pharmaceutical requirements will be combined to provide an effective, proactive and aggressive/robust internal audit program for any regulated industry. Software, data integrity, and cybersecurity issues. A suggested annual time line will be presented. The “must dos” when a notice is received of a pending FDA inspection.
This webinar can also be a significant part of meeting a company’s annual CGMP training requirement (if properly supplemented and documented).
Why Should You Attend:
There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance inspections (audits). These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.And business continues to 'shoot itself 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 much of their work for them. Failure to anticipate, find and correct compliance problems before an FDA site inspection can result in unnecessary 483 Observations, possible Warning Letters, or worst, and a competitive “hit” in the marketplace - all preventable by the effective internal CGMP compliance audit/inspection.
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. This information will be used to add to the FDA’s inspection “model”, to provide a field-tested approach to a company’s internal audit program. QSIT for medical devices and pharmaceutical requirements will be combined to provide an effective, proactive and aggressive/robust internal audit program for any regulated industry. Software, data integrity, and cybersecurity issues. A suggested annual time line will be presented. The “must dos” when a notice is received of a pending FDA inspection.
This webinar can also be a significant part of meeting a company’s annual CGMP training requirement (if properly supplemented and documented).
Areas Covered in the Webinar:
- Basic U.S. FDA's expectations - the CGMPs
- The 'target' - Tougher FDA Expectations/Requirements
- Avoid complacency from past 'good' FDA/Notified Body/ISO audits
- Key medical device and pharmaceutical CGMP concerns
- A risk-based phased approach
- FDA “model” CGMP inspections
- Prove/maintain 'in control'
- Fight “entropy”
Who Will Benefit:
- Senior and middle management.
- Quality Assurance
- Regulatory Affairs
- R&D
- Engineering
- Staff and Line personnel
- Sales and Marketing
- Operations/Production
Course Content
- Basic U.S. FDA's expectations - the CGMPs
- The `target` - Tougher FDA Expectations/Requirements
- Avoid complacency from past `good` FDA/Notified Body/ISO audits
- Key medical device and pharmaceutical CGMP concerns
- A risk-based phased approach
- FDA “model” CGMP inspections
- Prove/maintain 'in control'
- Fight “entropy”
Speaker
John E LincolnCourse Provider
John E Lincoln,
