Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard 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 selection, audit, use and on-going relations with its suppliers of services and products / components. How can companies address the FDA`s stated desire to require "on-site" audit of all Pharma suppliers? Expectations for meaningful, results driven actions that addresses and resolve any underlying compliance issues or product problems are increasing among regulatory agencies worldwide. To meet the new regulatory climate and be competitive, companies need to reevaluate their vendors and the methods used in selecting, evaluating, auditing, retaining or cutting adrift such regulatory "partners".
Why you should attend: 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. Companies are outsourcing more; with some thinking they can also outsource some of their cGMP compliance as well. Thus, the U.S. FDA has indicated that a key area gaining attention is a company`s suppliers, for services and products / components. Why needed? FDA expectations? How are successful companies meeting this challenge? Tools that need to be put in place or enhanced. Meeting the challenges of more "on site" audits. Getting supplier buy-in. Coping with "rogue" suppliers.
Areas Covered in the Session: - Regulatory "Hot Buttons"
- Classify suppliers; Supplier requirements by "classification"
- What`s behind the COA? The COC?
- The FDA`s increasing emphasis on the site audit
- Types of remote audits
- Maintaining the relationship
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
