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:
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.
In this course, you will receive a thorough overview of the clinical supply chain from beginning to end, including: designing appropriate packaging and labeling to match the study design, creating a plan of action to prepare the CTM and how to implement the plan and troubleshoot.
This course has been updated to include the new revised EU GMP Annex 11, and an update on 21 CFR Part 11.
Control for Critical Environments: HVAC Design Concepts -
(T14) New Course
Instructor: Norm Goldschmidt
This course provides insight into the theoretical basis and practical application of environmental control for Pharmaceutical, Biotechnology, Vaccine, Medical Device and Combination Device companies.
Oral Solid dosage forms (Tablets and Capsules) are some of the most popular and convenient methods of drug delivery. They can be produced in a non-sterile environment and the process, equipment and technology is well defined and known, after more than 100 years of development.
This course is relevant to individuals involved throughout the product lifecycle in validation of products and processes, in establishing and implementing Process Performance, Product Quality Monitoring, and Change Management systems in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management.
This course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's 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.
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.