These module will provide insight into what the FDA is looking for during an audit and provide participants with tools and case studies for each of the topics.
Why Should You Attend
The FDA is a regulatory body that can shut down a manufacturing facility then the company loses time and money due to the closure. For this webinar series, we are providing the most common observations given by the FDA and provide ways to prevent these most common observations.
- Who should be conducting an investigation?
- When is an investigation necessary?
- What constitutes an investigation?
- What is a root cause?
- What tools can be used to determine the root cause?
- What if a root cause could not be determined?
- Corrective Actions/Preventative Actions
- Case Studies of Investigations and Actions
Case Study 1
Case Study 2
Case Study 3
Who will Benefit
- Manufacturing Personnel (Associates and Supervisors) and Managers.
- Quality Control Personnel (Associates and Supervisors)
- Quality Assurance Personnel (Associates and Supervisors)
- New Graduates just entering into the Pharmaceutical Manufacturing Industry
Industries who can attend
This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel
Faculty John E Lincoln
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software 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).