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NSF International

Quality Insider

IRCA-Certified Training for Pharmaceutical QMS Internal and Lead Auditors

Meets training requirements of ICH Q10—“Pharmaceutical Quality System”

Published: Monday, February 27, 2012 - 12:57

(NSF-DBA: Ann Arbor, MI) -- In response to growing industry and regulatory demand for certified training courses tailored to the needs of pharmaceutical quality management lead and internal auditors, NSF-DBA has developed an audit and self-inspection course. The NSF-DBA Effective Pharmaceutical Audits and Self-Inspections course is certified by the International Register of Certificated Auditors (IRCA) as meeting the auditor training requirements of the new Guidance for Industry, ICH Q10—“Pharmaceutical Quality System” standard.

NSF-DBA, which has provided pharmaceutical industry training for more than 25 years, developed this course to ensure pharmaceutical quality management systems auditors are highly trained in good manufacturing practices (GMPs) and ICH Q10.

This is more important than ever as global pharmaceutical companies base important decisions on the results of quality audits conducted by internal and lead auditors. Decisions such as approving suppliers and contractors, determining whether in-house practices and procedures are acceptable, and deciding issues of overall regulatory compliance are often based on the results of quality management system (QMS) audits.

As a result, pharmaceutical companies and regulators now place even greater emphasis on the training and development of auditors and self-inspectors. The NSF-DBA course was created to provide the education, training, and development needed for external and internal auditors to help them fulfill this critical role.

“The pharmaceutical industry faces serious challenges such as contaminated or counterfeit products making their way into legitimate pharmaceutical supply chains,” says Vincent Desmond, deputy director of IRCA. “Regulatory agencies in the United States, Europe, and worldwide have put a hard focus on supply-chain assurance. The NSF-DBA Effective Pharmaceutical Audits and Self-Inspections course is the first IRCA-certified training course specific to the new IRCA Pharmaceutical Quality Management Systems auditor scheme, and will supply the level of training and competency the industry needs to overcome these challenges.”

“Prior to NSF-DBA’s IRCA-certified course, the pharmaceutical industry relied on general ISO 9000 auditor quality training, which provided little training specific to pharmaceutical quality and GMPs,” says Mike Halliday, a NSF-DBA partner. “This training course offers pharmaceutical professionals a means to truly demonstrate their auditor competence in GMPs and the ICH Q10 model, which will prepare them for their important role in ensuring pharmaceutical quality and safety.”

Seven NSF-DBA IRCA-certified Audit and Self-Inspection courses will be taught this year throughout South Africa, the United Kingdom, the United States, Germany, and the Netherlands. Visit NSF-DBA's website for a complete list of course schedules, or contact:
• Europe: Gill Gibbeson at 44 (0) 1751 432999, gg@nsf-dba.com
• United States: Kate Principe at (617)-342-3625, kate.principe@nsf-dba.com

NSF-DBA has provided high-quality training courses for the pharmaceutical, dietary supplement, and medical-device industries worldwide for more than 25 years. It is part of NSF International’s Health Sciences Division, which also includes NSF Reference Standards and NSF Pharmalytica, a GLP/GMP contract analytical laboratory based in the United States.

The International Register of Certificated Auditors (IRCA) is the world’s largest international certification body for QMS auditors. IRCA-certification programs recognize the competence of auditors who audit quality, environmental, occupational health and safety, software development, information security, food safety management systems, and now pharmaceutical QMS supported by the NSF-DBA training program.

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NSF International

Manufacturers, regulators, and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF’s mission is to protect and improve global human health. As an independent, accredited organization, its standards group facilitates the development of standards, and its service groups test and certify products and systems. NSF also provide auditing and risk management solutions for public health and the environment.