Fremont 2016 Webinar on FDA Observations in the Laboratory
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Description: | Overview: In this webinar the discussion will begin the non-conformances in the laboratory most often cited by the FDA and the pertinent regulation. This will be followed by a discussion of specific observations that relate to the laboratory cited in Warning Letters and FDA 483s. Why should you Attend: All laboratory personnel should be aw are of the current compliance issues and how to prevent FDA 483 and Warning Letter observations so that they may be proactively alert, identify problem areas and implement corrective actions in order to prevent regulatory actions Areas Covered in the Session: The most common FDA observations that apply to the laboratory The regulations and standards that apply to laboratory operations Specific warning letter and 483 observations that apply to laboratory operations including: Analysis of deficiencies Procedures that will prevent similar observations Assessment questions that might be used by a manager to determine if a similar non-conformance exists in the laboratory Who Will Benefit: Laboratory managers Laboratory supervisors Laboratory analysts Quality Assurance managers Quality Assurance record reviewers Speaker Profile: Jerry Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Read more at : http://www.compliance4all.com/control/w_product/~product_id=500991LIVE |
URL: | http://www.compliance4all.com/control/w_product/~product_id=500991LIVE |
Status: | Deleted |
Date: | Thursday, September 29, 2016 |
Time: | 2:00pm-3:30pm UTC |
Duration: | 1 hour 30 minutes |
Access: | Public |
Created by: | compliance4all |
Updated: | Friday, August 12, 2016 7:09am UTC |
: | $ 150.00 |
: | 18004479407 |
: | support@compliance4All.com |
: | Event Manager |
: | 800-447-9407 |
Comments: | None |