Customer Testimonials
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Subscribe NewsletterMeet the New, Tougher FDA Expectations
Product Id
:
600095
Overview: The last few years have seen the U.S. FDA come under increasing negative public scrutiny.
High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based. Most Warning Letters will not have an initial judicial review, resulting in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. Additional actions are being driven by the need to 'encourage' more voluntary compliance by industry. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can companies learn from the experiences of others, and break out of the "business as usual" mold to proactively address and eliminate any such "triggers", reduce "fire fighting" and minimize / eliminate major systemic compliance problems.
High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based. Most Warning Letters will not have an initial judicial review, resulting in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. Additional actions are being driven by the need to 'encourage' more voluntary compliance by industry. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can companies learn from the experiences of others, and break out of the "business as usual" mold to proactively address and eliminate any such "triggers", reduce "fire fighting" and minimize / eliminate major systemic compliance problems.
Areas Covered in the Session:
- Regulatory "Hot Buttons"
- The "target"
- Avoid complacency from past "good" audits
- Problem areas
- The desired response
- Where to shift focus / direct scarce resources now
- Maintain "the edge"
- Monitor for Effectiveness In the Changed Environment
Who Will Benefit:
- Senior management, project leaders, internal / external consultants
- Mid-level management and supervisory personnel
- Corporate and site coordinators
- Regulatory affairs
- Quality systems personnel / QAE
- R&D and engineering staff
- Production personnel
- New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach.