This change control webinar will discuss the change control activities and documentation required to meet GMP requirements.
Why Should You Attend:
This webinar will discuss and evaluate the effects that the recent call for change in the FDA has on a company. It focuses on one of the key contributor to product quality problems and GMP compliance failings -- 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. 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 recognized what constitutes a "change", and then continually reevaluate their change control system and its interfaces, as well as its impact on all areas of a company’s cGMP activities.
This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated change control activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance and past problems. It will help attendees understand and recognize the most common change control failings and their fixes, and assist in defining and recognizing changes.
Areas Covered in the Seminar:
- Defining a "change" and "change control".
- Tougher FDA Expectations / Requirements.
- Areas impacted.
- FDA "Hot Buttons".
- Design Control.
- Document Control; Archiving.
- Identifying "changes".
- Preventing negative changes and entropy.
- Maintain a ‘state of control’.
Who Will Benefit:
This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Neutraceutical and Biologics fields. The employees who will benefit include:
- Senior management
- Regulatory affairs
- Quality Assurance / QAE
- Production
- Engineering, R&D, and software development and testing teams
Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
