How to Withstand an FDA Audit of your Facility
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| Description: | This training on managing FDA audits will discuss practical tips to be prepared for an FDA audit of your facility, the appropriate conduct during an audit and the follow-up activities to an audit. You will learn the Do’s and Don’ts of an FDA inspection to ensure a successful audit. 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. Areas Covered in the Seminar: -Types of FDA audits -Key guidelines available from FDA -Preparing for the inspection -Logistics of the FDA audit -Follow-up to an FDA audit -Do's and don'ts of an FDA audit Who Will Benefit: This webinar will provide valuable assistance to all personnel in: -QA/QC/Compliance/ Regulatory affairs professionals -Senior management executives (CEO, COO, CFO, etc) -Manufacturing managers, supervisors & personnel -Clinical and preclinical laboratory managers -Clinical trial specialists -Project Managers -People investing in FDA-regulated product development projects |
| URL: | http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701869?channel=telesemin |
| Date: | Thursday, December 12, 2013 |
| Time: | 3:00pm-4:00pm UTC |
| Duration: | 1 hour |
| Access: | Public |
| Category: | Business*, Health*, Webinar* |
| Created by: | Public Access |
| Updated: | Wednesday, November 27, 2013 10:21am UTC |
| : | 249 |
| : | +1-650-620-3915 |
| : | referral@complianceonline.com |
| : | Referral |
| : | +1-650-620-3915 |
| Comments: | None |