“All three are valuable additions to the NSF Health Sciences team. Together, their combined 70 years of experience in pharmaceutical quality systems and global supply chain best practices will assist companies in meet their quality and compliance goals."
Ann Arbor, MI (PRWEB) November 27, 2012
NSF International, a global independent public health organization that writes standards, and tests and certifies products for the health sciences, water, food, and consumer goods industries, has welcomed three leading pharmaceutical and biotech experts to its Health Sciences Division.
- Janeen Skutnik joins as a Partner with the Boston-based U.S. team of NSF-DBA, an NSF International company with over 25 years of experience delivering training, auditing and consulting to the pharmaceutical and medical device industries.
- Stephen Engels joins NSF-DBA as a Principal Consultant, overseeing operations in Switzerland, Italy, Germany and Austria.
- Peter Langlais joins as Business Development Director for the entire NSF International Health Sciences Division.
The NSF International Health Sciences Division offers training and education, consulting, auditing, GMP and GLP testing, certification, R&D and regulatory guidance to the pharmaceutical, biotechnology, medical device, over-the-counter and dietary supplement industries throughout the product lifecycle.
Janeen Skutnik, Partner, NSF-DBA USA
As regulatory agencies worldwide have increased their focus on pharmaceutical quality and supply chain practices in the face of globalization, there is an even greater emphasis on quality systems and training.
In her new role as a Partner at NSF-DBA USA, Janeen will address these and other issues by providing high quality training and consulting to leading pharmaceutical, biotechnology, medical device and dietary supplement companies. Janeen’s expertise in the area of excipients and over-the-counter products will assist NSF-DBA customers in complying with new and emerging quality regulations and global supply chain best practices.
Throughout her career, Janeen has worked closely with government and industry groups to help shape key regulations and quality standards that have improved pharmaceutical quality and global supply chain practices. This includes working with the International Conference of Harmonisation (ICH) work groups and trade groups such as Pharmaceutical Research and Manufacturers of America (PhRMA) and the Consumer Healthcare Products Association (CHPA). She is an active member of the Parenteral Drug Association (PDA), serving on its Regulatory Affairs and Quality Advisory Board (RAQAB), and she regularly speaks at PDA-FDA Quality and Supply Chain workshops and seminars. Janeen also serves as the Chair of the International Pharmaceutical Excipients Council (IPEC) Federation.
Janeen has served in many leading quality assurance roles at both Pfizer and Merck, including Director and Team Leader of Quality and Regulatory Policy at Pfizer. She earned a Bachelor of Science degree in chemistry from the University of Connecticut in Storrs, Connecticut.
Stephen Engels, Principal Consultant, NSF-DBA Europe
NSF-DBA’s new Principal Consultant Stephen Engels will oversee the company’s operations in Switzerland, Germany, Italy and Austria. Working closely with Janeen, Stephen will head quality management systems consulting, auditing and training activities. Stephen’s career in pharmaceutical quality and compliance spans more than 25 years. Stephen is a quality management systems expert with experience in supplier management, auditor development and regulatory compliance, including leading quality assurance roles at Merck Serono in Switzerland and Italy where he developed and implemented a global auditor qualification and training program as Head of its Quality Programs & Systems Development.
Stephen also served as a member of the EAQ (quality experience exchange) group of Interpharma, the association of Swiss research-based pharmaceutical companies. He speaks fluent English, Italian, German and French and has a Bachelor of Pharmacy (BPharm) degree from Rhodes University in Grahamstown, South Africa.
Peter Langlais, Business Development Director, NSF Health Sciences Division
Peter Langlais joins as Business Development Director for the NSF Health Sciences Division, which includes NSF-DBA, NSF Pharmalytica, NSF Becker, NSF Reference Standards and NSF’s Dietary Supplements group. Langlais has more than 24 years of sales and marketing experience with suppliers to major pharmaceutical and biotech firms. In his new role, he will help expand NSF’s services in biotechnology, pharmaceutical, reference standards, medical device and dietary supplement markets.
Peter has previously led business development, marketing, sales, clinical diagnostics and global distributor networks for companies in the pharmaceutical, biotech and medical device industries, including Tripos, IGEN International and Associates of Cape Cod, Inc. His work complements NSF International’s recent acquisition of Becker & Associates Consulting, Inc., a leading clinical, regulatory and scientific consulting firm specializing in medical devices, pharmaceuticals and biologics. Peter earned a Bachelor of Science degree in biology from Western New England University.
“Stephen and Janeen’s innovative approach to quality assurance in the pharmaceutical and biotechnology sectors has made them both a widely sought resource for government officials and global pharmaceutical companies, and Peter’s experience working with global pharmaceutical and biotech companies will help NSF Health Sciences expand our services to new areas,” said Lori Bestervelt, Ph.D., NSF International Chief Science Officer and Senior Vice President. “All three are valuable additions to the NSF Health Sciences team. Together, their combined 70 years of experience in pharmaceutical quality systems and global supply chain best practices will help NSF assist companies in meet their quality and compliance goals.”
For more information on NSF International’s Health Sciences services, contact HS@nsf.org, 617-342-3625 or visit http://www.nsf.org/business/health_sciences/index.asp.
Editor’s note: If you would like to set up an interview with an NSF expert, email Greta Houlahan at firstname.lastname@example.org or call 734-913-5723.
About NSF International (http://www.nsf.org): Based in Ann Arbor, Mich., USA, NSF International is a global independent public health organization that writes standards, and tests and certifies products for food, water, health sciences and consumer goods industries. Established in 1944, NSF is committed to protecting human health and safety worldwide and operates in more than 150 countries. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment.
NSF Health Sciences Division offers training and education, consulting, auditing, GMP and GLP testing, certification, R&D and regulatory guidance for the pharmaceutical, medical device and dietary supplement industries throughout the product lifecycle. The division also supplies pharmaceutical secondary reference standards, traceable to USP and EP standards. NSF wrote the only accredited American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard. The NSF Health Sciences Division operates globally throughout North America, Europe, the Middle East, Africa, Asia and Latin America.
NSF International offers ISO 13485 registrations 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. Additional services include safety audits for the food and water industries, environmental and sustainability services through NSF Sustainability and training courses through the NSF Training and Education.