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. Training Courses are:
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.
This course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits and provide tools to manage all project resources.
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.
Q7A: Implementing Good Manufacturing Practices (T30)
Instructor: Jack Chu, Manager of Technical Support, EM&U-BTM Operations/Commercialization at West Point, Merck & Co., Inc.
This course reviews and interprets the key GMP requirements specific to bulk biopharmaceuticals and familiarizes participants with the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
This course provides an overview of biotech manufacturing processes used to make biopharmaceuticals. Discover the underlying principles of proteins and cells which will provide a basic understanding of how and why the processes manufacture therapeutic proteins.
Sterile Product Manufacturing Facilities: Applying the new ISPE
Baseline® Guide and FDA Guidance Principles to Design and Operation (T12)
Instructor: Mark von Stwolinski, Vice President Architectural Services, Clark Richardson & Biskup (CRB) Consulting Engineers
This course uses the newly published second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's newly published Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities.
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.