Research and Markets has announced the addition of the "Managing Your FDA Inspection: Before, During and After" conference to their offering.

The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection. There should be no surprises if you have prepared properly. Firms need to understand the details about inspectional techniques to avoid making new problems for yourself during the inspection. You can save yourself a lot of corporate misery if you know what to do before, during and after an inspection.

FDA conducts inspections based on well established procedures. You can lower your anxiety level when you can predict what they will do during an inspection, what products they cover and how they will document your problems. Any type of regulated firm should the ground rules of an inspection to keep it under control. You should be able to see the hand writing on the wall if it looks bad and prepare accordingly. You should understand what is at stake based on the progress of an inspection.

How you respond to an investigator, to the inspection in general and to the FDA can seal your fate to an unhappy ending if you don't know what to do, how to do it and how fast you need to do it. Questions are encouraged. What did you want to know about FDA, but were always afraid to ask? What are the big mistakes firms make? Here the firsthand accounts of an ex-FDA investigator.

Agenda:

Day 01 (8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration

09.00 AM: Session Start

9:00 - 10:30 a.m.

- FDA Legal Authority

- FDA inspection plans and risk

- Preparing for an inspection

Break 10:30 - 10:45 a.m.

10:45 - 12:00 p.m.

- FDA Inspection Procedures

- FDA staff guidance

- FDA staff training

Lunch 12:00 - 1:00 p.m.

1:00 - 2:30 p.m.

- Inspection strategy and technique (cont.)

Break 2:30 p.m. - 2:45

2:45 - 4:30p.m.

- Inspection strategy and technique

- War rooms

Day 02(8:30 AM - 4:30 PM)

9:00 - 10:30 a.m.

- Documenting violations

- Collecting samples

- Responding to inspectional observation (The 483)

Break 10:30 - 10:45 a.m.

10:45 - 12:00 p.m.

- Responding to a Warning Letter

- Legal enforcement actions

Lunch 12:00 - 1:00 p.m.

1:00 - 2:30 p.m.

- Recall actions and procedures

- The field District Office

- The Center(s)

- The recalling firm

- Notifying the public

Break 2:30 - 2:45 p.m.

2:45 - 3:00 p.m.

- Follow up inspections

- Corrective and Preventive Actions

3:00 - 4:30 p.m.

- Foreign inspections

- Import Alert

For more information about this conference visit http://www.researchandmarkets.com/research/wrldb5/managing_your_fda