FDA Inspections – Do's and Don'ts
Price Details
Overview:
Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.
Areas Covered in the Session:
Who Will Benefit:
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.
Why should you Attend: If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections:
- How can your company be prepared for an FDA inspection?
- How should your company respond to a 483 or warning letter correctly the first time without hiring a costly law firm?
- What can an FDA inspector legally ask for during an inspection and what can you refuse to show the investigator?
Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.
Areas Covered in the Session:
- Define the steps necessary to prepare for an FDA inspection
- Discuss details surrounding the management of inspections from announcement to close out meeting
- Offer responses to FAQs regarding typical inspector requests during inspections
- Define the methodology for responding to 483 and warning letters
- Discuss common pitfalls to avoid during an inspection
- Define the steps necessary to prepare for an FDA inspection
- Discuss details surrounding the management of inspections from announcement to close out meeting
- Offer responses to FAQs regarding typical inspector requests during inspections
- Define the methodology for responding to 483 and warning letters
- Discuss common pitfalls to avoid during an inspection
- Define the steps necessary to prepare for an FDA inspection
Who Will Benefit:
- Internal Auditors
- Regulators
- Legal Departments
- Compliance Officers
- Validation Managers
- QC Managers
- QA Managers
Speaker Profile
Jonathan M. Lewis has over twenty-two years' experience in the areas of executive management, quality control (QC), quality assurance (QA), manufacturing, regulatory affairs, validation, and project management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, dietary supplement, food, and animal food industries.
Prior to founding Reliant FDA Experts, a division of Advanced Biomedical Consulting (ABC), LLC, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level Validation Engineer to an Associate Director of Consulting.
Mr. Lewis has also worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/Validation Manager. In addition, Mr. Lewis has worked at Telectronics Pacing Systems, a medical device manufacturer, as a Sterility Assurance Laboratory Technician.
Prior to founding Reliant FDA Experts, a division of Advanced Biomedical Consulting (ABC), LLC, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level Validation Engineer to an Associate Director of Consulting.
Mr. Lewis has also worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/Validation Manager. In addition, Mr. Lewis has worked at Telectronics Pacing Systems, a medical device manufacturer, as a Sterility Assurance Laboratory Technician.