RA/QA December Networking Event

"Data Integrity: How Does Data Integrity Fit Into Your Quality Management System"

with guest speaker, 

Dr. Charles Heldebrant, CSO, CQO, PSC Biotech

and opening comments by our host,

Sharon McNair, Quality Manger, Mannatech

Dr. Charles Heldebrant is the Chief Scientific Officer  and Chief Quality Officer at PSC Biotech. Dr. Heldebrant has over 28 years of pharmaceutical experience in varied positions at Alpha Therapeutic Corporation, where he oversaw research and development of biological products, including viral inactivation processes, and processes for production of Factor VIII, Factor IX and a1-Protienase Inhibitor.

He has over four years of high volume PCR testing experience with NGI/LabCorp and over seven years of regularoty and consulting experience in drugs, devices, nutritional supplements, foods and contract manufacturing with PSC biotech.

He also supervises Metrology and Computer System Validation for PSC Software.

Sharon McNair is a Quality Manager with Mannatech, Inc. In this role, she oversees the quality systems providing all aspects of quality management, inuding auditing, and training of the technical science group.

Befor joining Mannatech in 2003, Sharon worked for 5+ years for a diverse range of industries, including Oral Pharmaceuticals, Veterinary, and Environmental. Sharon's varied background in these industries provided the perfect foundation for quality management. With more than 17 years of experience, Sharon now focuses mainly on continuous improvement and  cGMP compliance.

Sharon is an ASQ Certified Quality Auditor. She received her Bachelor of Arts degree in Chemistry from Mississippi State University.