Date: | November 7, 2019 - 8:30am - November 8, 2019 - 4:00pm |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | Venue to be announced shortly, Boston, MA, 02101, United States, Venue to be announced shortly |
Website for Event: | https://www.complianceonline.com/fda-gmp-expectations-phase-i-first-in-man-clini... |
Topic: | Seminars and Workshops |
Description: | Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects. The following steps to establish the appropriate manufacturing environment for phase 1 investigational drugs should be taken: A comprehensive and systematic evaluation of the manufacturing setting (i.e., product environment, equipment, process, personnel, materials) to identify potential hazards The following topics will be discussed to provide the foundation and basis for advancing drugs into clinical development from research and providing required information to the FDA regarding these products. |
Contact Name: | Ashutos Swain |
Contact Email: | referral@complianceonline.com |
Contact Phone: | 8887172436 |