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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 on November 11, 2011 at 9:01am
Quality Planning: What is it and why do we need it?
Quality planning is the identification and documentation of various activities within the quality management system that demonstrate control over the process to assure compliance. There are many different aspects to quality planning referenced throughout ISO standards and regulatory requirements, such as 21 CFR 820. Basically, a quality… Continue
Posted on September 29, 2011 at 7:42am
Is Your Executive Management Team as Involved with the Quality System as they should be?
We’ve all heard of the recent FDA decisions to increase the focus of inspections on management with executive responsibility. There have been at least two Warning Letters issued to date in 2011 with observations related to this area. While there are 26 references related to the role of executive management within the Quality System Regulation (QSR 21 CFR 820), these Warning Letters addressed two basic… Continue
Posted on July 6, 2011 at 12:01pm
How Effective is Your Internal Audit Program?
A strong internal audit program can provide executive management with an overall view of the health of the quality system. In my opinion, it is one of the most critical subsystems in the quality system. When effective audits are performed AND meaningful metrics are generated, quality system strengths and gaps become more evident to executive management.
So how do you determine if your internal audit program is effective? It’s more than just generating non- conformances and…
Posted on July 6, 2011 at 11:30am
Where Did GMP Go?
The basic concept of Good Manufacturing Practice (GMP) is based on two key quality principles:
• Processes and procedures are designed and validated to assure products are manufactured to meet specification and perform as expected for the customer.
• Employees are trained on processes, follow procedures and empowered to stop the line whenever there is a problem or failure.
While GMP is a requirement in regulated industries, the basic principles are applicable in…
Posted on July 6, 2011 at 11:30am
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