2nd Edition  Conference

FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

"Overview of Good Manufacturing Practices"
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.


  • GMP Requirements for a Phase 1 Study,Personnel documentation and requirements,
  • Manufacturing & Records during phase 1 studies with an eye toward later development
  • Control of components, containers and closures – methods and specs,Overview of GMP requirements
  • Specific requirements for various types of products: biologics, combinations, sterile products
  • Process Validation to conduct for phase 1 clinical supply process,Vendor selection & management


8:30 AM - 4:00 PM (Nov 07) (General)
8:30 AM - 4:00 PM (Nov 08) (General)

Entry Fees

Paid Ticket Starts from 1699 USD View Details



5 Exhibitors Estimated Count

Category & Type

Medical & Pharma
Packing & Packaging


07 - 08 Nov 2019 2nd Edition
15 - 16 Aug 2019 1st Edition

Frequency Bi-annual
Next edition likely in May 2020

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Eric Simonson

Eric Simonson

Scientist at The Centre for Drug Research and Development

Coquitlam, Canada
Ashutos Swain

Ashutos Swain

Marketing Manager at Complianceonline

Palo Alto, United States
Jonathan McInnis

Jonathan McInnis

Researcher at NIH/DMID/ORA

Rockville, United States

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1699 USDAttendee Seminar One Registration
37.578000 -122.348000

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Venue to be announced

Burlingame, USA

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