Who Should Attend?
This introductory/intermediate course is designed for individuals who need a basic, but thorough understanding of the Qualification Process for equipment and systems in support of Process Validation for the manufacture of pharmaceutical sterile and oral solid finished dosage forms biologics and bulk active ingredients through the use of IQ, OQ, PQ Protocols. The course will benefit individuals in:
- Technical Services/Validation
- Quality Control/Assurance
- Regulatory Affairs
- University and allied health care professionals
The installation/operational/performance qualification/ verification of equipment, systems, facilities and processes for pharmaceutical sterile, oral solid dosage biologics, finished and bulk manufacturing operations are an essential part of the validation process. Equipment must be installed, operated and maintained within design specifications and facilities must be accepted as fit for use, while processes must be shown to be reliable, all of which to assure the consistent quality and integrity of the product. Furthermore, this course provides a basic and thorough understanding to preparing, executing, reviewing and approving protocols. A Risk Based approach to impact critically assessment is also provided along with an overview of ICH Q9 Quality Risk Management and ASTM E 2500 International Consensus Standard approaches now being applied by the Industry and Regulatory authorities to define Qualification (Verification) requirements.
Protocol examples/workshops will be utilized to enhance the learning, however this course will not provide a library of completed protocols.