ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, is partnering with a major American university for the first time to provide comprehensive, hands-on biotechnology training 12-14 May at North Carolina State University’s Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh, North Carolina, USA.

“ISPE is proud to be a part of this innovative partnership with North Carolina State University to bring a unique training experience to pharmaceutical professionals,” said Bruce Davis, Chairman of ISPE’s International Board of Directors.

The training program will offer four three-day courses that include lectures, problem-solving workshops, and hands-on activities at BTEC’s state-of-the-art cGMP pilot plant facility. Participants will learn how to implement new concepts, improve process efficiency, address manufacturing challenges, and much more.

The BTEC facility simulates a biomanufacturing pilot plant capable of producing biopharmaceutical products and packaging them in a sterile environment using commercial-scale equipment. It is currently the only facility in the U.S. that can do this from inoculation to filling, and the partnership between ISPE and North Carolina State University is one of the few opportunities for professionals to receive this hands-on, industry-specific training.

Developed for professionals in the pharmaceutical manufacturing and biotechnology industries to help increase knowledge in their respective fields, the training will focus on current issues, including:

• Process Validation for Biotechnology Manufacturing
• Biopharmaceutical Manufacturing Facilities
• Getting the Most from Your Bioreactor
• Disposables in Biomanufacturing: An Objective Assessment

Recognized industry experts will present relevant curriculum to give professionals the tools they need to be successful in their careers while earning Continuing Education credits. In addition, several of the courses contain information related to competencies for the Certified Pharmaceutical Industry Professional SM (CPIPSM).

For more information on specific courses and instructors, please visit www.ISPE.org/BTECtraining.

Share This

Elizabeth Martinez Flores, Director General for Terra Farma in Mexico City, Mexico, has met the global competency standard and has been conferred the Certified Pharmaceutical Industry Professional (CPIP ^SM ) credential by the ISPE Professional Certification Commission (ISPE-PCC).

Martinez Flores is one of the seven professionals to be awarded this new certification and was assessed through demonstrated education, industry experience, and a rigorous examination. The new credential offers the first competency-based international certification for pharmaceutical professionals and covers a range of competencies from drug product development through manufacturing.

The new certification offers enhanced credibility, peer respect and recognition, and greater opportunities for professional advancement.

Martinez Flores has been an ISPE Member since 2002. She has a Bachelor’s degree as a Chemical Pharmaceutical Biologist from the Autonomous National University of Mexico, and a Master’s degree with Honorary Mention in Industrial Management from the Autonomous National University of Mexico.

Martinez Flores has extensive experience as an auditor and speaker in Brazil, Chile, Colombia, the Dominican Republic, El Salvador, Mexico, Peru, Venezuela, and the United States, including Puerto Rico. She has expertise in quality systems, good manufacturing practices, handling and dispensation of drug products in pharmacies, among other topics. She has been a speaker in numerous national and international meetings — including ISPE — and at least 25 other organizations.

In addition, Martinez Flores is certified by the American Society for Quality as an HACCP auditor, a quality auditor, quality manager, biomedical auditor, and a quality improvement associate. She is also an RABQSA-certified quality auditor, a COFEPRIS-recognized speaker, and has been certified by the Mexican Institute of Normalization and Certification.

To learn more and obtain a CPIP eligibility application (free download) visit www.ispe-pcc.org.

Share This