Training Courses 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. Training Courses are:
The course will also cover regulatory requirements including USP, EP, and JP Monographs, the FDA Guide to Inspections of High Purity Water Systems, current FDA views, and current Good Manufacturing Practice (cGMP) requirements.
This course provides an overview of biotech manufacturing processes used to make biopharmaceuticals. The course surveys commonly used manufacturing processes, including cell culture and fermentation; harvest and recovery; viral removal and inactivation; and purification processes such as tangential flow filtration, centrifugation, and size exclusion and adsorptive chromatography.
As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. FDA's risk-based regulatory initiatives focus new attention on the risks of cross-contamination.
This course provides insight into the theoretical basis and practical application of environmental control for Pharmaceutical, Biotechnology, Vaccine, Medical Device and Combination Device companies.
Risk Based Verification of Facilities, Systems
& Equipment (T48) - New Course
Instructor: Dan Franklin
Through interactive workshops participants will more fully understand and apply the principles of ASTM E 2500-07 and ICH documents (Q8 (R2), Q9, and Q10) to the documented verification that pharmaceutical and biopharmaceutical facilities, systems and equipment that are suitable for their intended purpose.
This course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes.
This course will explore the essential concepts and principles of specification, design, commissioning / qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing.
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.