PME 530:Introduction to Pharmaceutical Manufacturing
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
Renata Shnayder is an Adjunct Professor in the Pharmaceutical Manufacturing program at Stevens. She has broad engineering background and extensive experience in pharmaceutical manufacturing operations, technology transfer and validation of pharmaceutical processes and facilities for tablets, capsules, powders, and aerosols, full understanding of validation principles, Good Manufacturing Practices, FDA regulations and guidelines, and compliance concepts. She also works as a Technical Manager, Validation and Process Management, in the Global Technical Services group at Schering-Plough. She provides technical expertise and detailed project support to manufacturing sites and global corporate teams for technology transfer and process validation of new and existing solid oral dosage forms. Such support ranges from consultation services, problem solving and troubleshooting, to preparation, development, execution, and documenting validation studies. Ms. Shnayder received her B.S. and M.S. degree in engineering from College of Chemical and Mechanical Engineering in Moscow, Russia.
Research & Education
Education
Ms. Shnayder received her B.S. and M.S. degree in engineering from College of Chemical and Mechanical Engineering in Moscow, Russia.
Experience & Service
Experience
She has broad engineering background and extensive experience in pharmaceutical manufacturing operations, technology transfer and validation of pharmaceutical processes and facilities for tablets, capsules, powders, and aerosols, full understanding of validation principles, Good Manufacturing Practices, FDA regulations and guidelines, and compliance concepts. Her full-time job is a Technical Manager – Validation and Process Management in the Global Technical Services group at Schering-Plough, where she provides technical expertise and detailed project support to manufacturing sites and global corporate teams for technology transfer and process validation of new and existing solid oral dosage forms. Such support ranges from consultation services, problem solving and troubleshooting, to preparation, development, execution, and documenting validation studies.