Conference 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
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
Course benefit:
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.

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
Who will Benefit:
Directors
Manager
Supervisors
Lead workers in Regulatory Affairs Quality Assurance and Quality Control
Workers who will prepare GMP documents for early phase products
Workers who will review GMP documents for early phase products