6 Hours Virtual Seminar: FDA's GMP Expectations for Phase 1 and First-In-Man Clinical Trials

Karl M. Nobert

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This Course covers FDA's statutory and regulatory requirements governing the development and use of investigational drug products for first-in-human clinical trials. It will provide a comprehensive look at the Current Good Manufacturing Practices (cGMPs) applicable to early stage human clinical testing from beginning to end. Several general categories will be covered including amongst others, Preclinical Testing Considerations, cGMPs for Phase I Investigational Drugs, the Regulation of Biologics for Investigational Use, and Human Clinical Trial Considerations. Attention will also be given to the specific rules applicable to each of these categories. Finally, the presenter will offer strategies for compliance with applicable Phase I Clinical Testing obligations and for mitigating the risk of Agency enforcement action. A time for participant questions will be provided.

Course Objective

Attendees will leave the Course clearly understanding the Processes and cGMP Requirements for parties sponsoring and conducting "first-in-human" Phase I Clinical Trials. The webinar is intended to provide participants with an understanding of:

  • How early-stage human clinical trials are regulated in the United States.
  • FDA's requirements governing the development and use of investigational drug products and biologics for Phase I / First-In-Human Clinical Trials
  • How to design and implement a Manufacturing Plan and Quality Controls to ensure the safety of subjects while complying with FDA's regulatory requirements
  • Reliance on preclinical testing as the building block for future human testing
  • Special considerations for Sterile Products/Aseptically Processed Products 
  • Agency's current focus on Pharmacovigilance
  • Recent FDA enforcement action in the space and how to mitigate the risk of being the subject of such action

Course Outline

10:00am – 12:00pm Session 1
I. Overview
  • Statutory and Regulatory Overview
  • Investigational New Drugs vs. Approved Drug Product
  • Preclinical & Clinical Trial Phases
  • General IND Regulations (21 CFR Part 50)
II. Preclinical Trial Considerations
  • Good Laboratory Practices ("GLP")
  • Nonclinical Studies
  • Protocol Design 
  • Pharmacology Studies
  • Toxicology Studies
  • Other Studies  
12pm- 1pm Lunch
1pm - 2:30pm Session 2:
III. Recommended cGMP for Phase I Investigational Drugs
  • Personnel 
  • QC Function  
  • Facility and Equipment 
  • Control of Components, and Containers and Closures 
  • Manufacturing and Records 
  • Laboratory Controls 
  • Testing 
  • Stability 
  • Packaging, Labeling, and Distributing 
  • Recordkeeping
IV. Biological and Biotechnological Products
  • Overview
  • Composition, Quality, and Safety
  • Product Characterization
  • Personnel
  • Facility and Equipment
  • Manufacturing Process
  • Quality Controls
  • Safety-Related Functions / Purposes
  • Testing 
  • Recordkeeping
  • Product Modifications 
2:30pm - 2:45pm Break
2:45pm - 4pm Session 3:
V. Sterile Products/Aseptically Processed Products
VI. Human Clinical Trial Considerations
  • Human Subject Protection (21 CFR Part 50)
  • General Overview
  • Informed Consent
  • Financial Disclosures (21 CFR Part 54)
  • Institutional Review Boards (21 CFR Part 56)
  • Clinical Investigators 
  • Additional IND Requirements
  • Clinical Trial Design
  • Conducting Trials in Humans
  • Pharmacovigilance 
VII. Regulatory Compliance
  • Facility Inspections 
  • Enforcement Action Types
  • Recent Enforcement Action Case Studies
  • Compliance Strategies for Mitigating Risk
VIII. Questions 

Target Audience

  • Clinical Operations Staff 
  • Project Team Members
  • Quality Assurance, Monitors, CRAs
  • Regulatory Affairs
  • Investigators & Site Study Staff
  • Clinical Trial Supply 
  • CROs, Consultants, Insurer
  • Directors
  • Manager
  • Supervisors
  • Lead workers in Regulatory Affairs Quality Assurance and Quality Control
  • Workers who will prepare GMP documents for early phase products
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Karl M. Nobert,

Karl M. Nobert focuses his practice on the representation and counseling of clients in the food and drug industry including advising clients on matters related to the regulation of human prescription and nonprescription drugs, human and veterinary biological products including regenerative medicine, medical devices, food and dietary supplements. Karl also assists clients with the preparation of FDA submissions including human and veterinary new drug and generic drug applications; 510(k) premarket notifications, premarket approval applications, recalls and market withdrawals, GRAS self-affirmations and notifications, and product listings and establishment registrations. He represents clients before the Food and Drug Administration (FDA), United States Department of Agriculture (USDA) and Federal Trade Commission (FTC). Karl also represents clients in State food and drug law matters on various regulatory matters including wholesaler/distributor licensing and registration. Karl currently serves as Legal Advisor to the International Veterinary Regenerative Medicine Society (IVRMS) and is a member of the National Thoroughbred Racing Association’s (NTRA) Safety and Integrity Alliance Subcommittee on Aftercare. He is the author of numerous articles and frequently presents on various FDA regulatory topics.

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