Enhanced credibility.

Peer respect and recognition.

Greater opportunities for professional advancement.

A competitive edge when job seeking.

Those are some of the benefits that pharmaceutical manufacturing professionals can gain with certification as a Certified Pharmaceutical Industry Professional ^SM(CPIP^SM) made available through the ISPE Professional Certification Commission (ISPE-PCC).

This new credentialing program offers the first competency-based international certification for pharmaceutical professionals and covers a range of competencies from drug product development through manufacturing. Candidates are assessed through demonstrated education, experience, and a rigorous examination.

The 2007 exams for the new certification for pharmaceutical manufacturing professionals will be available to the industry: • 9 July - 4 August • 5 November - 8 December.

The CPIP program is hailed by many in the industry as beneficial to team leaders, allowing the ability to impact greater quality and efficiency in their specific roles.

“Our industry benefits from employees certified in diverse knowledge, and with the ability to apply this knowledge across all segments of our industry,” said Ali Afnan, PhD, of the United States Food and Drug Administration.

According to Donovan Wearne, CEO of SeerPharma Pty Ltd.: “SeerPharma provides expert QA and GxP consulting services to the pharmaceutical, biotechnology, and medical devices industries. In our business our reputation and success absolutely depends on the technical knowledge, innovation and responsiveness to change of our consulting team,” said Wearne. “The CPIP credential is therefore a perfect fit with our corporate vision and aspirations for our consultants and business,” Wearne said. “We intend to strategically use the CPIP credential now and in the future to qualify our team and support their ongoing professional development.”

According to Jerry Roth, P.E., Director of Professional Certification, likely candidates for this credential are those who work in drug product development; drug product manufacturing operations; facilities/process engineering; facility and process equipment manufacturing and supply; project management; regulatory compliance/ QA/Validation; and technical support. Eligibility applications should be submitted at least 60 days prior to exam dates.

Those CPIP candidates deemed eligible by the PCC will be authorized to register for and take the exam. The examination will be available in Thomson Prometric Professional Testing Centers located in major cities around the world. Eligible candidates will be able to make a reservation on-line at a local testing center close to their work or home.

To obtain a CPIP eligibility application (free download) or to purchase the CPIP Study Guide, visit www.ispe-pcc.org.

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The ISPE Washington Conference will offer the opportunity for facility professionals to attend the ISPE Facility Summit 2007: Innovative Ideas for Accelerating Performance, featuring 2007 Facility of the Year Awards Category Winners.

In a “town hall” style gathering, the ISPE Facility Summit 2007 welcomes top thinkers and service practitioners from our community to give insight and help advance “the facility of the future.” Hear how manufacturing assets can accelerate the capture of future opportunities and best support an enterprise’s strategic objectives today, and tomorrow.Design, project delivery, regulatory, manufacturing technology, and operations, all delivered through “rapid-fire” sessions, breakouts, panel discussions, armchair case studies, and virtual tours with the Facility of the Year Awards (FOYA) 2007 Category Winners. The goal of this first Summit is to deliver a broad pallet of key design issues, yet focus on manufacturing challenges.

Seminar Leaders will be:
Brian Lange, PE, Director of Engineering, Merck & Co., Inc.
Terry Jacobs, AIA, Principal, Jacobs/Wyper Architects, LLP
Andy Signore, PE, CEO, IPS
 

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ISPE’s Washington Conference … an exclusive opportunity for you to be seen and heard by industry regulators; to discuss real world solutions with industry experts; and to attend important seminars like this one …Product Quality Lifecycle Implementation (PQLI): Practical Approach to Quality by Design Co-sponsored by the US FDA, this two-day event is a critical foundational opportunity for attendees to engage with regulatory and industry leaders to help craft a pragmatic approach to implementing Q8 and Q9 for the industry. Keynote sessions will address the 21st century perspective on the product quality lifecycle. 

Leaders from science, manufacturing, quality, and engineering will be able to engage with the US FDA and other regulatory agencies to turn Q8 and Q9 into a cross-functional and practical reality, helping to shape the future thinking of our industry on a global level. The goal of these sessions is to begin to define areas where industry will be able to provide the technical framework for the implementation of QbD in regulatory submissions.  PQLI will examine Q8 and Q9 and identify the subjects/terms that need to be further elaborated, as well as explain why there is a need for a clarification. Six highly interactive workshops will focus on NCEs (vs. biotech drugs) and will cover: API Design Space, DP Design Space, API Critical vs. Non-Critical, DP Critical vs. Non-Critical, API Control Strategy Traditional vs. Quality by Design (QbD), and DP Control Strategy Traditional vs. QbD. For complete seminar details and to register, go to Product Quality Lifecycle Implementation: Practical Approaches to Quality by Design (QbD) - co-sponsored by the FDA

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