Successfully Navigating an FDA Inspection
How do you prepare for an FDA inspection? What happens during an inspection? What do you do and how do you respond to the FDA after receiving the inspection results? These questions and more were answered during a two-hour webinar where FDA and industry leaders addressed how to prepare, manage, and successfully complete an inspection.
This CD is essential for quality assurance and regulatory affairs personnel, manufacturing and operations managers, compliance managers, design and validation engineers, auditors, and consultants. You'll have an opportunity to hear from an FDA field investigator and industry experts who have recently been through an inspection. The webinar CD includes: complete audio of speaker presentations, audience question and answer sessions, and printed copies of the handout materials.
PROGRAM-AT-A-GLANCE
| Overview of FDA Inspection Process - How FDA decides to visit a manufacturer - FDA notification process - How FDA prepares for an inspection -Overview of QSIT program -Update on third-party inspection program |
Results of an Inspection - Categorizing results of the inspection - Other possible actions - Inspection results - Follow-up by FDA - FDA's inspection data analysis |
| Best Practices for Manufacturers When Preparing for an Inspection - Internal procedures for an inspection - Roles and responsibility for staff |
Manufacturers Response After an Inspection - Responding to observations - Follow-up communication with FDA - How to conduct internal analysis to determine scope of corrections - Strategies for implementing improvements to your quality system |
| What Happens During an Inspection - Best practices - Managing the inspection |
SPEAKERS
- Vera Buffaloe, Buffaloe Consulting
- John Sawyer, CQA, Vice-President, Quality Assurance & Regulatory Affairs, Welch Allyn
- Alan Gion, Consumer Safety Officer, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, U.S. Food and Drug Administration (FDA)
WEBINAR CD
- Includes handout material and CD
- $295 for webinar registrants | $395 for non-registrants
- Please note: domestic and international shipping rates apply
THREE WAYS TO PURCHASE
1. Phone – 1-877-249-8226/240-646-7031 to order with credit card.
2. Fax – Select and download the order form and fax to 240-396-5781 .
3. Mail – Select and download the order form and mail with payment to:
Inspections Webinar CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact Publications at 1-877-249-8226 / 240-646-7031.