New York Professional Events List

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

Nov 11, 2021 - 08:00 AM - Nov 12, 08:00 AM
Compliance Online
Courtyard Boston Cambridge
777, Memorial Dr

ZIP: 02139

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

Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
Download Brochure

        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
        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:

    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

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

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2020, she was Vice President of Regulatory Affairs at Insmed (2/2020-5/2020) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2020). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).

Please contact Marilyn Turner: Phone: +1 929 900 1853  Email: marilyn.turner [a] for registrations

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