Why is FDA at My Facility, and What Do I Do During an Inspection? - San Diego, CA, United States - February 23-24, 2017 Seminar

Dublin, Jan. 11, 2017 -- Research and Markets has announced the addition of the "Why is FDA at my facility, and what do I do during an inspection?: 2-day In-person Seminar" conference to their offering.

This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME's) to respond properly, and how to respond to an FDA 483 or Warning Letter. Case Studies and Templates are included.

This course begins with a high level discussion about why FDA conducts inspections and the sanctions available to FDA for those companies who choose not to comply with FDA requirements. Next, we cover what to expect during the inspection, including how to communicate with the investigators, run your front and back rooms, and present documents and records.

We cover do's and don'ts, choosing your core inspection team, facilitators, Subject Matter Experts (SME's), runners and scribes. We provide tips for Executive Management/CEO's, Production area staff, Reception Area staff and what each group needs to know during an inspection. The session includes real life inspection scenarios/case studies. Participants are given real life FDA inspection scenarios and are asked to discuss how they would handle each situation. Feedback is given on how to best handle each situation and scenario. This is one of our most popular training sessions!

Agenda:

Day One (8:30 AM - 5:00 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start Time: 9:00 AM

FDA Law and Inspection Training

1. FDA Management and General Training
a. Legal Obligations
b. Management Responsibility from FDA's view

2. Front Room Back Room
a. Your FDA Inspection Team
b. FDA Inspection SOP
c. Front Room/Back Room
d. Putting it all together

Day Two (8:30 AM - 4:30 PM) SME training, 483/Warning Letter Response

3. SME Training
a. Basic Ground Rules for everyone
b. Role of the SME
c. FDA Interviews
d. How to get the best out of the inspection
e. Say NO to
f. Do's and Don'ts

4. Replying to 483s and Warning Letters
a. General Points to Consider
b. The Response
c. Templates
d. Let's not forget
e. When and How to do updates

Key Topics Covered:

Day One (8:30 AM - 5:00 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start Time: 9:00 AM

FDA Law and Inspection Training

1. FDA Management and General Training
a. Legal Obligations
b. Management Responsibility from FDA's view

2. Front Room Back Room
a. Your FDA Inspection Team
b. FDA Inspection SOP
c. Front Room/Back Room
d. Putting it all together

Day Two (8:30 AM - 4:30 PM) SME training, 483/Warning Letter Response

3. SME Training
a. Basic Ground Rules for everyone
b. Role of the SME
c. FDA Interviews
d. How to get the best out of the inspection
e. Say NO to
f. Do's and Don'ts

4. Replying to 483s and Warning Letters
a. General Points to Consider
b. The Response
c. Templates
d. Let's not forget
e. When and How to do updates

For more information about this conference visit http://www.researchandmarkets.com/research/x52vf6/why_is_fda_at_my

CONTACT: Research and Markets
         Laura Wood, Senior Manager
         [email protected]
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         Related Topics: Business