New IRCA-certified NSF-DBA course meets auditor training requirements of the new Pharmaceutical Quality Management System Standard (ICH Q10 model)
KIRKBYMOORSIDE, North Yorkshire, United Kingdom and ANN ARBOR, Mich. (February 23, 2012) – 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 a first-of-its-kind 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 Pharmaceutical Quality Management System Standard (ICH Q10 model).
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 the Pharmaceutical Quality Management System Standard (ICH Q10 model).
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 audits. Regulatory agencies around the world have placed an increased focus on supply chain assurance in the face of challenges that include contaminated or counterfeit products making their way into legitimate pharmaceutical supply chains.
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 Effective Pharmaceutical Audits and Self-Inspections 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. Regulatory agencies in the US, 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," said Vincent Desmond, Deputy Director, IRCA.
"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. This new NSF-DBA training course offers pharmaceutical professionals a means to truly demonstrate their auditor competence in GMPs and the new Pharmaceutical Quality Management System Standard (ICH Q10 model), which will prepare them for their important role in ensuring pharmaceutical quality and safety," said Mike Halliday, NSF-DBA Partner.
Seven NSF-DBA IRCA-certified Audit and Self-Inspection courses will be taught this year throughout South Africa, UK, US, Germany and the Netherlands. Visit NSF-DBA's website for a complete list of course schedules. For more information about the IRCA-certified NSF-DBA Effective Pharmaceutical Audits and Self-Inspections course, visit NSF-DBA's website or contact:
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 U.S. The International Register of Certificated Auditors (IRCA) is the world's largest international certification body for quality management systems 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 quality management systems supported by this new NSF-DBA training program.
Editor's note: To schedule an interview with NSF-DBA Partner Mike Halliday, contact Greta Houlahan at +1 734-913-5723 or Houlahan@nsf.org.
About NSF International: NSF International is an independent organization that writes standards, tests and certifies products for the health science, food, water and consumer goods industries to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment.
NSF International's Health Sciences Division offers certification, training, consulting, GMP and GLP testing, R&D and auditing for the pharmaceutical, dietary supplement and medical device industries. The Health Sciences Division includes; NSF-DBA, which has more than 25 years of pharmaceutical, dietary supplement, and medical devices training expertise; NSF Pharmalytica, a GLP & GMP contract laboratory; NSF Reference Standards and NSF Dietary Supplements Certification Program. NSF International developed the only American National Standard for Dietary Supplements (NSF/ANSI 173), and tests and certifies supplements against this standard. NSF's Health Science Division operates globally throughout North America, Europe, Middle East, Africa, Asia and Latin America.
Additional NSF International services include management systems registrations, such as ISO 13485 for medical devices, delivered through NSF International Strategic Registrations (NSF-ISR); food safety and quality programs through the NSF Food Safety Division; drinking water product certification through the NSF Water Division; sustainability services through NSF Sustainability, and NSF Education and Training programs.
CONTACT: Greta Houlahan