- Industries
- Solutions
- Partnerships
- Purchase Courses
- Resource Center
- About Us
- Contact Us
Pharmaceutical Communiqué: July - 2010
FDA Expands Global Inspection Training Program
FDA Commissioner Margaret Hamburg's remarks during the DIA plenary session last week underscore the agency's concerns over globalization. Citing issues ranging from last year's tainted heparin and melamine incidents to increased counterfeiting, multi-layered supply chains and decentralized quality organizations, the agency has ramped up its overseas programs.
Specifically, Dr Hamburg spoke of the new FDA offices in Asia, Latin America and other locations, the increased focus on inspections of facilities outside the US, and inter-agency collaboration in high risk regions.
>>Read the full article by registering for access to this content
Course Overview "Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations"
Authored by the FDA, and now part of the FDA Inspection & Enforcement Library, this course on the Postmarketing Adverse Drug Experience Reporting Program (PADE) represents CDER's current thinking on how field postmarketing ADE reporting inspections support CDER's drug safety surveillance activities.
The course provides an overview of PADE regulations, guidance, inspectional candidate selection, inspectional techniques and regulatory actions to enhance the field investigator's knowledge.
>>Read the full article by registering for access to this content
Training Effectiveness Self-Evaluation
During our Leaders in Life Science Learning Events in 2009, we captured many "best practices" from Quality professionals at leading firms about building effective training management. We decided to list them in an self-evaluation form to help Quality Managers evaluate their own programs.
We invite you to download this self-evaluation to gauge how your quality training program compares to some of the best practices.
And stay tuned for an upcoming schedule of Leaders in Life Science Learning events during the second half of 2010!
>>Read the full article by registering for access to this content