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, labelling, and documentation requirements will also be reviewed and explored.

COURSE BENEFIT

SPEAKERPeggy J. Berry, MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)

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 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) 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 (3/2009-2/2014). 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).

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

2-Day In-Person Seminar by Ex-FDA Official:

By: Peggy J. Berry, MBA, RAC, President & CEO, Synergy Consulting (Ex-FDA Official)

Location: FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials San Francisco Airport, CAAugust 21-22, 2018

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 DESCRIPTION

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

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 2 Topics

Day 1 Topics

02FDA'S GMP EXPECTATIONS FOR PHASE I AND FIRST-IN-MAN CLINICAL TRIALS2-Day In-Person Seminar by Ex-FDA Official:

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

AGENDA

DAY 1 (8:30 AM - 4:00 PM) DAY 2 (8:30 AM - 4:00 PM)

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

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

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

FDA'S GMP EXPECTATIONS FOR PHASE I AND FIRST-IN-MAN CLINICAL TRIALS2-Day In-Person Seminar by Ex-FDA Official:

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FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials San Francisco Airport, CA August 21-22, 2018..............................................................................................................................................................................................................................................

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FDA'S GMP EXPECTATIONS FOR PHASE I AND FIRST-IN-MAN CLINICAL TRIALS2-Day In-Person Seminar by Ex-FDA Official:

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