“I am proud to congratulate NSF-DBA on its new, larger home in downtown Boston,” said Boston Mayor Thomas M. Menino. “I look forward to your continued success and growth in our city, one of the world's top life sciences hubs.”
NSF-DBA offers high quality training, auditing and consulting services that address the rapidly changing needs of pharmaceutical, biotechnology, medical device and dietary supplement companies. The move was necessitated by a growing demand for its services as regulatory agencies worldwide have increased their focus on pharmaceutical quality and supply chains in the face of globalization. Increased regulatory enforcement activities and the challenges of contaminated or counterfeit ingredients making their way into legitimate supply chains require an even greater emphasis on quality systems and training.
Evidence of this can be seen in the increased levels of warning letters issued by the U.S. FDA in recent years for Good Manufacturing Practices (GMP) violations and recent focus on management and the effectiveness of Pharmaceutical Quality Management Systems. As a result, pharmaceutical companies and regulators now need to place an even greater emphasis on the training, currency and competence of their staff.
“NSF-DBA's courses, run both in-house at companies or as public courses for professionals in the pharma, medical device and dietary supplement sectors, are in increasingly high demand, as well as our auditing and consulting services,” said Neil Wilkinson, NSF-DBA Senior Partner. “Now strategically located near the city of Boston's leading biotech development center, NSF-DBA can assist U.S. pharmaceutical and biotech companies on crucial development, manufacturing and supply chain issues throughout all stages of the product lifecycle for an increasingly global market.”
NSF-DBA was the first organization to develop an accredited training course for pharmaceutical auditors. 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 based on global GMPs and ICH Q10 (Pharmaceutical Quality System).
"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, which will prepare them for their important role in ensuring pharmaceutical quality and safety," said Mike Halliday, NSF-DBA Partner.
NSF-DBA is part of NSF International's Health Sciences Division, which offers certification, training, consulting, GMP and GLP testing, R&D and auditing for the pharmaceutical, dietary supplement and medical device industries throughout the entire product lifecycle. 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, the Middle East, Africa, Asia and Latin America. NSF International offers ISO 13485 registration for medical devices and CE Marking delivered through NSF International Strategic Registrations, Ltd. (NSF-ISR), as well as drinking water filtration certification through the NSF Water Division.
For more information on NSF-DBA services, contact Kate Principe at 617-342-3625 or or visit here. For more information on upcoming trainings, visit NSF-DBA's course schedule.