GMP & Occupational Exposure Requirements to Manufacture High Potent Sterile Products in Shared Facilities

Extended Learning
Learning Level: Intermediate
Session Length: 2 hours

Contamination and Cross Contamination Control in shared Facilities to protect the product, the operators, and the environment, especially working with highly potent/toxic sterile pharmaceutical substances. The session will cover the GMP and Occupational Safety Requirements for highly potent sterile products, Cleaning requirements for non-product contact surfaces as in filling line Isolators, room, and airlocks. Separation vs Segregation, Single Use System compared to CIP/SIP, Air Handling Unit as single pass compared to air recovery/ air recirculation, Facility design as well as personnel and material flow.

Learning Objectives

  1. Learn about what technical and organizational measures are needed to manufacture sterile high potent/toxic Pharmaceutical products in liquid and/or powder form.
  2. Learn how to fulfill GMP and Occupational Safety during manufacturing.
  3. Benefit from the lessons learned from a multi-international company dealing with different global regulatory authorities and their expectations of manufacturing highly potent/toxic substances in shared facilities.

$99 members/$149 nonmembers

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Speaker

Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Christian Mrotzek
Sr. Director Technology Center
Fresenius Kabi USA, LLC
Christa B. Myers
Pharmaceutical Market Director
CRB