World Conference Calendar

32875 Conferences

How to withstand an FDA audit : A primer for clinical sites

Added by Referral on 2011-01-19

Conference Dates:

Start Date Start Date: 2011-02-10

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This FDA Audit webinar training will discuss the types of audit and what are the activities to be done before, during and after FDA audit to pass it successfully and how to increase credibility for your company.

Why Should You Attend:

If your company is marketing a product or service that is regulated by the FDA, you should be prepared for an FDA audit. If you have never been audited by the FDA or if you were last audited 4-6 years ago, if any product or service you offer has been in the news – positive or negative, or if you are getting ready to submit a clinical trial or marketing approval application, chances are you would get audited by the FDA in the near future. Although different facilities are subject to different regulations, FDA auditors follow some general guidelines that are common across all.

We will discuss the general rules and specific case studies to highlight the common themes and differences across facilities subject to GCP, GMP or GLP regulations. This webinar will discuss ways to be prepared for an FDA audit, conduct during an audit, and follow-up activities to an audit. Learn how convert an FDA audit into an opportunity to demonstrate high quality products and services, and to increase credibility in the industry for your company.

Areas Covered in the Seminar:

Types of FDA audits
Key guidelines available from FDA
GCP/GMP/GLP requirements. Why inspections are conducted and by what statutory authority?
Reasons for FDA conducting an inspection.
What to expect from an audit? What is subject to FDA purview and what's off-limits?
Preparing for the inspection/Audit - What you need to know and do to prepare for, during and even after the inspection, a ctions to be taken upon the investigator's arrival, required documentation, Individual responsibilities for the inspection.
Logistics of the FDA audit/Inspection
Follow-up to an FDA audit - What to do next? How to respond to findings and facilitating the documentation and remediation process…and reaching final closure?
Do's and don'ts of an FDA audit/Inspection.

Note: Use this promocode(117660) for 10% discount.
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