Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)
This pharmaceutical manufacturing training course will assist pharmaceutical, biotechnology, and CRO researchers and managers in understanding the requirements for a well-designed and successful ADME, PK/TK, and DM program conducted within a drug development logic plan and in compliance with ICH guidelines.
Upon completing this course, participants will have a basic knowledge of the research studies conducted to characterize the likelihood of success for a drug candidate (either a small organic molecule (NCE) or macromolecule) after administration to animal models and humans.
Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)
This course will provide participants with a comprehensive understanding of the terminology, regulations and mandated practices for GLP testing and compliance.
By the end of this three-day course, attendees will have a strong understanding of the fundamental compliance requirements for current Good Laboratory Practices, and will be able to apply compliance protocols in all efforts aimed at generating regulated data for evaluation by the US FDA, USEPA and regulatory agencies overseas.
Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)
This GCP training course provides a solid understanding of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will gain experience in detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites.
