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6-Hour Virtual Seminar on Phase I GMP

October 1 @ 8:00 am - 2:00 pm CDT

$445

Overview

Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower doses of the drug product.  Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail.  Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

Details

Date:
October 1
Time:
8:00 am - 2:00 pm CDT
Cost:
$445
Website:
https://www.planurevents.com/virtual-seminar/6-hour-virtual-seminar-on-phase-i-gmp-10532live

Organizer

94539
Phone:
18003851627
Email:
hrtrainonline@gmail.com
Website:
https://hrtrainonline.com

Venue

Online Event
Compliance Key,364 E Main Street, Suite 1009
Middletown,DE,USA, DE 19709 United States
+ Google Map
Phone:
+1 7172088666
Website:
https://www.compliancekey.us/webinar/1707/filing-irs-form-1099-nec-w-9-update/source_ccln