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Defining The Documentation Lifecycle That Best FitsYour Organization:
This training will help answer the question of what level of documentation is required to effectively meet the need of your organization.. -READ MORE CLICK HERE
Part 211 Drug GMP:
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This e-textbook contains over 280 pages; 30 individual documents from subparts B-K.
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Blog Posts
Who makes the best SME (subject matter expert) during an FDA inspection?
A Subject Matter Expert (SME) or domain expert is a person who is an expert in a particular area or topic. When faced with the FDA or another regulatory agency, we tend to call on SMEs that are most intimate or familiar with the details of the process or product in question. In some cases, we reach too deeply into the organization to an individual that has comprehensive knowledge of technical/processes, but not effective at explaining this information. Thus, we open the door to unnecessary…
ContinuePosted by B Christine Park on November 22, 2011 at 10:13pm
Another Tool for Your Survival Kit
It is indisputable that life science companies, like all other businesses, are struggling to survive in these very rocky economic times. Uncertainty regarding the future of healthcare costs and global financial stability, unpredictability regarding certain FDA positions (e.g., will 510(k) rules be relaxed or not?, how will FDA regulate supplements?, increased/decreased regulatory burden on brand-name drugs?), difficulty in raising capital and resulting fear of hiring additional…
ContinuePosted by Glenn Melvin on November 11, 2011 at 9:01am
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