Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public.
Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems. Change can be beneficial, but is often the cause of new and even worse problems than those the change was designed to eliminate. It can be the root cause of a major problem, cGMP "entropy". Proper change control is required to resolve any underlying compliance issues or product problems that are increasingly seen by regulatory agencies and consumers worldwide. To meet this new regulatory climate and be competitive, companies need to continually reevaluate their change control system and its impact on all areas of a company’s cGMP activities.
Why you should attend: The last few years have seen an increase in product recalls. For this and other reasons, the U.S. FDA has 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 and subjected to greater scrutiny. Failure to comply will result in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. A key area for maintaining cGMP compliance is Change Control. Yet it often is a company’s weakest link in compliance - proven by recent high-profile failures. Why so? FDA expectations? How are successful companies meeting this challenge? Tools that need to be put in place or enhanced. Getting personnel buy-in. Getting senior management buy-in. Supplier buy-in.
Areas Covered in the Session: - Change Control – what it is; what it is not
- Areas impacted by Change Control
- Regulatory / FDA 483 “Hot Buttons”
- Design Control
- Document Control
- Identifying changes
- Preventing negative changes
- Maintain a `state of control`
- Business needs and obtaining `buy-in`
Who Will Benefit: - Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants; others tasked with project leadership responsibilities
