Recorded Webinar: FDA Inspections: What to Expect and How to Prepare

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Robinson
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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: Dr. James Harris

OVERVIEW:
When an FDA agent arrives at the front door of your manufacturing site, he fully expects to be greeted promptly and be given full access to any part of the facility and all records covering manufacturing including raw material specifications, approved su

While the inspector has the right to almost anything he/she wants, they do not have the right to everything. This presentation gives methods of preparation for inspections and methods of conducting and controlling the process. A simple organization that is prepared to host FDA inspectors and facilitate inspections will make the process much more satisfactory for all involved. This presentation tells how to prepare and conduct inspections and how to handle difficult moments. This presentation is essential for every pharmaceutical manufacturer and the people within that organization.
Why should you attend:
Every well run pharmaceutical manufacturing facility has established a team of its personnel who will be responsible for hosting an FDA inspection, providing assistance as needed, and monitoring their activities. This program is a vital preparation for the inevitable FDA inspection. It will help sharpen your skills and prepare team members for the inevitable day of inspection This presentation will prepare a manufacturer for FDA inspections, suggest methods for managing the inspection, and assure a smooth and pleasant inspection.

Areas Covered in the Session:
- Basic Preparation
- The host team
- Rules
- FDA’s arrival
- The inspection
- Typical points of FDA interest and how to handle
- Validation
- The exit interview
- The 483
- What to do after FDA leaves
- Follow-up inspections
- What to avoid

Who Will Benefit:
- Production supervisors, Managers, and Directors
- Quality Control and Quality Assurance supervisors, managers, and directors
Inspection host team

SPEAKER PROFILE:
Dr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. During his tenure in the pharmaceutical industry, he was very active in industry groups. He served on the PMA's Validation Advisory Committee and was chairman of the Computerized Systems Advisory committee where he wrote the original guideline on computer validation and negotiated its acceptance with FDA. While consulting, he and his consulting teams have assisted numerous clients around the world with validation of their manufacturing processes.

After your payment, we will contact you with instructions about how to access the webinar.
After your payment, we will contact you with instructions about how to access the webinar.
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