Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: John E. Lincoln
There is a continuing 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.
Control and review of device changes are a major requirement in determining when to file a new 510(k). 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 hard to achieve but required to resolve any underlying compliance issues or product problems that are increasingly seen by regulatory agencies and consumers worldwide. To meet these regulatory challenges and remain competitive, companies need to continually reevaluate their change control system and its impact on all areas of a company’s cGMP activities.
Why should you attend: The last few years have seen an increase in product problems. 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. Larger, higher profile companies are coming under FDA investigation activities. Many failings can be traced to poor or weakly documented Change Control. Documented and reviewed Change Control is crucial to device 510(k) submission requirements. Yet it often is a company’s weakest link in compliance – proven by these recent high-profile failures. Why so? What are FDA expectations? Where are the most likely failure points? How are successful companies meeting this challenge. Tools that need to be put in place or enhanced. Getting staff and line personnel buy-in. Getting senior management buy-in. And getting 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 and Filing a New 510(k)
– Document Control
– Identifying Changes
– Preventing Negative Changes and Entropy
– Give the FDA It’s Desired ‘State of Control’
– Business Needs and Obtaining Stakeholder ‘Buy-In’
Who Will Benefit:
– Senior management in Drugs, Devices, Biologics, Dietary Supplements
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.