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I not only ask my people to become Members, but also ask them to get involved with ISPE groups, like those working on the details of ISPE's technical guides and publications. Just being a Member is not good enough. You can only learn by getting involved.
Ulrich Rudow, V.P. Worldwide Engineering & Real Estate
Johnson & Johnson, USA
Watch the Video:
True Stories: What it means to be an ISPE Member - (WMV, 16 MB)
(Click to begin, or right-click to download and view later)
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Training |
Auditing for GMP
Upcoming Dates and Locations
Description
Good manufacturing practice (GMP) requires good manufacturing auditors. Auditors must perform their jobs competently to ensure their company's compliance with pharmaceutical GMP regulations and other quality standards. Without qualified and well-trained auditors to evaluate performance, standards cannot be adequately reviewed, thus limiting performance improvement. This course will contribute to the improvement of auditor performance within a regulated industry.
Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities. Participants will learn how to prepare for more effective audits, conduct internal and vendor audits, formulate and ask good questions, properly evaluate and report audit findings, and provide recommendations for corrective actions.
Take Back to Your Job
- Identify the critical competencies needed to be a conscientious auditor
- Understand the concepts behind compliance auditing
- Evaluate information to anticipate and prevent problems, rather than correcting problems after they occur
- Prepare to perform an audit
- Conduct an audit using an audit trail and checklist
- Effectively evaluate audit and report findings and involve management in follow-up activities
Attendance Suggested For
- Professionals who are responsible for conducting internal or vendor GMP audits
- Suppliers and others who are audited, such as quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management
Continuing Education Units
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.
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