Training Courses are two-day events that are a great place for your employees to work interactively with industry experts and peers to gain valuable skills and knowledge. Our instructors work in the industry and face the same daily challenges you do.
This course will cover regulatory philosophy, aseptic process and equipment considerations, aseptic clean room design and operation, differential pressure requirements, airlocks, basic utility systems, European HVAC considerations, basic commissioning and qualification issues, and a brief introduction to barrier isolation technology.
Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8, Q9, and Q10 and ASTM E-2500.
GMP Auditing for the Pharmaceutical Industry (G07)
Instructor: Jeri Weigand, Senior Principle Quality Specialist, Medtronic
Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry.
Oral Solid Dosage Forms: Understanding the Unit Operations, Process,
Equipment and Technology for OSD Manufacture (T10)
Instructor: Jack Chu, PE, Assistant Director Capital and Asset Lifecycle Management, Merck
The course will begin with a description of the three main OSD processing methods: Direct Compression, Wet Granulation and Dry Granulation. It will continue with a detailed review of all the major unit operations associated with OSD manufacturing processes.
HVAC for Pharmaceutical Facilities (T14)
Instructor: Norman Goldschmidt
This course will provide a detailed description of HVAC system fundamentals, including a discussion of primary system components such as fans, coils, humidifiers, and filters.
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course.
ISPE will provide continuing education units (ISPE CEUs) for all North American courses. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials.
Some courses contain knowledge related to the CPIP™ Technical Knowledge and Competency Elements. For complete information concerning the knowledge elements or the CPIP™ Credential, please visit www.ISPE-PCC.org. The ISPE Professional Certification Commission does not endorse any of these resources, products, or services offered relative to the CPIP™ certification program.