About the Webinar
For over a decade India has been a key link in the global supply chain of Pharmaceuticals, supplying not just API’s, but complete dosage forms.
As manufacturing becomes more sophisticated and closer to the end user, the patient, regulatory expectations increase.
In this class we will discuss how FDA expectations for environmental control compare with EMA - PIC/S, WHO and others.
Join ISPE India for an educational session led by Norman Goldschmidt of Genesis AEC.
Norman will focus this session on the environmental controls and monitoring necessary to manufacture common therapies while maintaining regulatory compliance.
Norman Goldschmidt
Mr. Goldschmidt has over 35 years of experience spanning the many types of facilities and processes necessary to bring a product to market, from R&D through Manufacturing.
Norman is internationally recognized as a Life Sciences Expert and author with
extensive experience in Biopharmaceutical Manufacturing and R&D including: Sterile filling, Vaccine and Biotech API processing, Cell & Gene Therapy, Pharmacies and dispensing and overall cGMP Regulatory Compliance.
Norman has authored the Environmental Control & HVAC and related sections of 7 ISPE Guides as well as numerous articles and papers. He has trained regulators across with world (FDA, USDA, HCA, TGA, MHLW) and is a frequent speaker and instructor for ISPE, PDA, ASHRAE, NSF and others. Mr Goldschmidt holds 4 patents for innovations in HVAC and Pharmaceutical Processing and is an International Standards Organization (ISO) cleanroom delegate and expert/author.
5 авг 2024
