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Pharmaceutical Communiqué: January - 2010
Audit and Inspection Readiness... New Course Videos Available
You may be looking to help your quality team prepare for FDA, ISO, EU inspections. And while each inspector or auditor has significantly different approaches, areas of expertise and regulatory responsibilities, there are "essential" guidelines that can help your team derive tangible benefits from the audit or inspection experience.
Kaplan EduNeering has captured an "Audit Readiness" presentation recently given at our 2009 EU Knowledge Summit. The 60-minute presentation has been sliced into 11 course video segments, which you can assign via the Kaplan EduNeering Platform just like any computer-based course.
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Understand the Massachusetts Conduct Regulation
A new course covering the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation is now available.
Although the regulation has similar provisions to the recently revised AdvaMed and PhRMA Codes of Ethics, it is considered the most stringent in the nation. It imposes a number of additional restrictions on pharmaceutical and medical device manufacturing companies' (including distributors') interactions with health care practitioners.
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New Course: "Enforcement Changes at the New FDA"
With all of the changes made by FDA in 2009, and the long-term impact these activities will have on regulatory and quality programs, we have just produced a new course: "GMP Updates -- Enforcement Changes at the New FDA," which outlines FDA priorities, including:
Dr. Hamburg has stated that "we must get the word out that the FDA is on the job." The agency has outlined "Six Initial Steps" designed to hone the effectiveness and timeliness of FDA's regulatory and enforcement system. This new course delves into these six steps, which include post-inspection follow-up and warning letters.
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