Articles
RSSPrestigious Industry Credential Awarded To Danish And American Pharma Colleagues
May 18, 2009
Tampa, FL - Peter Werner Christensen, CPIP, Senior Quality Professional with NNE Pharmaplan, and Sam DeMarco, CPIP, President of Compliance Team, Inc., have met the global competency standard and have been conferred the Certified Pharmaceutical Industry Professional (CPIPTM) credential by the ISPE Professional Certification Commission (ISPE-PCCTM).
Christensen and DeMarco are two of 14 professionals to be awarded this new certification and were assessed through demonstrated education, industry experience, and a rigorous examination. The credential offers the first competency-based international certification for pharmaceutical professionals. It represents a global standard and covers a range of competencies from drug product development through manufacturing.
The CPIP certification can unlock greater career opportunities and provide a development pathway for pharmaceutical professionals. It also provides industry-wide recognition of accumulated experience, while giving employers and suppliers a competitive advantage by ensuring that their professionals have diverse knowledge and skills that are certified to a global competency standard.
Peter Werner Christensen has been an ISPE Member since 2002. He has more than 30 years of experience in the medical device, pharmaceutical, software, telecommunication, and railway safety systems industries where he has managed risk, reliability engineering, and validation according to GMP standards and US FDA regulations.
Christensen began his career at S&W Medico Teknik, where he worked "hands-on" in all of the quality disciplines and became knowledgeable about standardization and international approvals. As Quality Manager within different companies, he has assisted the company's management in business development, establishing corporate culture, and establishing and managing new departments in connection with ISO 9001 and TQM. He has lectured about GAMP, validation, risk management, and the new paradigm of pharmaceutical manufacturing with the use of Quality by Design, QbD, worldwide. He is currently managing projects that follow the new paradigms and ASTM E2500-07. Christensen graduated from the Technical University of Denmark in 1978 with a Masters of Science degree.
Sam DeMarco has been an ISPE Member since 1995. He has more than 20 years of experience in the pharmaceutical industry. His expertise includes engineering, commissioning, validation, project management, quality assurance, and compliance consulting for the pharmaceutical, biotechnology, and medical device industries.
DeMarco's project engineering and management experience began at Baxter Healthcare, where he was responsible for implementing and managing several aseptic technologies and facilities projects. As a consultant, he has managed remediation projects, as well as projects involving commissioning, qualification, and validation of pharmaceutical manufacturing facilities, process control systems, clean room facilities and HVAC systems, utility systems, process equipment systems, and network/IT computer systems. He has written corporate policy and advised multiple corporations on validation of process control systems. He is currently developing engineering quality management system policies and templates for clients implementing a risk-based ASTM E2500 commissioning and qualification program. DeMarco has a Bachelor of Science in Mechanical Engineering from the University of Illinois, and a Master of Business Administration from Loyola University of Chicago, both in the USA.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical science and manufacturing professionals in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; its Asia Pacific office in Singapore; and its newly established office in Shanghai, China.
About the ISPE-PCC
The ISPE Professional Certification Commission (PCC), an autonomous governing body within ISPE, develops certification programs to benefit credential holders and their employers, as well as government, academia, and the public health product consumer. The PCC is composed of 12 commissioners: senior-level industry professionals representing Argentina, Australia, Japan, North America, the US Food and Drug Administration (FDA), and the general public.
SOURCE: ISPE
