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Who should attend FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
Directors, Managers, Supervisors and lead workers in Regulatory Affairs, Quality Assurance and Quality Control.
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Seminar Summary:

The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. (see full course description)

 
 
 

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Training Course Syllabus:


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
Appropriate actions prior to and during manufacturing to eliminate or mitigate potential hazards to safeguard the quality of the phase 1 investigational drug

Review the FDA recommendations and requirements for implementing a compliant program for the phase 1 clinical program.

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.

Overview of Good Manufacturing Practices

GMP Requirements for a Phase 1 Study
Personnel
QC Function
Facility and Equipment
Control of components, containers and closures
Manufacturing & Records
Laboratory Controls
Vendor selection & management
Process Validation
Special Considerations
Multi-product facilities
Biologics
Sterile products
Combination products
Providing relevant information in the IND application

Learning Objectives:

To gain an understanding of the requirements for drugs entering into phase 1 clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing manufacturing and quality strategies to meet FDA requirements.

Areas Covered:

Day 1 Topics

Overview of GMP requirements
GMP Requirements for a Phase 1 Study
Personnel documentation and requirements
QC Function procedures and requirements
Facility and Equipment requirements
Control of components, containers and closures – methods and specs
Manufacturing & Records during phase 1 studies with an eye toward later development

Day 2 Topics

Vendor selection & management
Process Validation to conduct for phase 1 clinical supply process
Specific requirements for various types of products: biologics, combinations, sterile products
Multi-product facilities considerations
Preparing relevant SOPs for early stage development
Providing relevant information in the IND application


DAY 01(8:30 AM - 4:00 PM)

8:30 – 9:00 AM: Registration
9:00 – 10:30 AM: Good Manufacturing Practices & Phase 1 Requirements
Core principles of GMP
Detailed review of FDA phase 1 guidance document
10:30 – 10:45 AM: Break
10:45 – 12:30 noon: Good Manufacturing Practices & Phase 1 Requirements, continued
Acceptable practices and practical tips
GMP requirements for exploratory clinical studies
12:30 – 1:15 PM: Lunch
1:15 – 2:45 PM: Good Manufacturing Practices & Phase 1 Requirements, continued
Personnel documentation and requirements
Facility & equipment requirements
Control of components
Specific requirements for specialty products
2:45 – 3:00 PM: Break
3:00 – 4:00 PM: Vendor Selection and Management
Planning for the early stage with an eye towards large scale manufacturing
Vendor management
Raw material handling issues for early stage products

DAY 02(8:30 AM - 4:00 PM)

8:30 – 10:00 AM: Overview of INDs Requirements & Expectations
FDA requirements for an IND submission
Expectations upon IND review
Format and content of the CMC section of an IND
10:00 – 10:15 AM: Break
10:15 – 12:00 noon: Overview of INDs Requirements & Expectations, continued
Characterization of the active ingredient and finished product
Various kinds of products: drugs, biologics, botanicals, diagnostics, medical devices
Manufacturing facility, personnel and equipment requirements
12:00 – 12:45 PM: Lunch
12:45 – 2:15 PM: Process Validation
Introduction to process validation for early stage manufacturers
Process validation reports and other documentation
2:15 – 2:30 PM: Break
2:30 – 4:00 PM: Creating SOPs Across all Stages of Development
What SOPs are required during early clinical development
When do additional SOPs need to be created
Ensuring that appropriate SOPs are in place for contractors
SOP processes and creation
QC function and responsibilities

Seminar Summary:

The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. (see full course description)

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