GMPs across the phases of development

Peggy J Berry

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This 8 Hrs series training is divided under 4 parts. 2 Hrs session each day/week. As follows:

6th May @12PM

13th May @12PM

20th May @12PM

27th May @12PM

Why You should Attend The Session 

Employ strategies within your company to save time and money in advancing clinical development.  This webinar will provide the information and tools that you need to understand different baseline GMP requirements for each stage of development; beginning with needs for IND submission and phase 1 studies, progressing to phase 2, phase 3, NDA/BLA submission, and commercialization.  Options to explore and considerations for each will be discussed so that you have tools to develop and implement strategies for your organization using a phase-specific staging program of GMP requirements.

Description Of The Topic 

Early clinical trials are conducted to establish the initial safety of a drug.  The studies are generally in a small number of healthy subjects and use lower or ranging doses of the drug product.  Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early-stage investigational products to be manufactured under “phase 1 GMPs,” allowing flexibility in some of the rigorous, expensive, and time-consuming requirements.  As clinical development progresses, evolving into “phase 2 GMPs” and into commercialization with a methodical and comprehensive planned approach can save substantial time and expense.

This series will include a detailed review of the current regulations as must be followed for commercialization as well as guidance documents with the flexibility in interpretation of the regulations for earlier stages of manufacturing in compliance with GMPs to support early clinical trials. 

Regulatory strategies, logistical considerations, and GMP-staging plans, options and alternatives, including raw material selection and receipt, vendor selection and management, stability programs, packaging and labeling, SOPs, documentation requirements, and validation will be discussed and explored through interpretations and case study examples.

Areas Covered During The Session

This webinar will be divided into 4 parts, each 2-hours in duration.  Case study examples, knowledge checks, and interactive Q&A will be used within the program.

Part 1:  Overall drug development and GMP timing

-       Planning for the IND

-       Gaining feedback on GMP plans

-       Resource and product consideration in planning

-       Quality Unit and oversight

-       General GMP considerations for every stage/phase

Part 2: GMP regulations and interpretation for early stages

-       Facility

-       Personnel

-       Equipment

-       SOPs

-       Documentation

Part 3: Continuation of part 2

-       Vendor selection, oversight, and management

-       Quality agreements and contracts

-       Auditing

-       Complaint handling

-       Change control

-       Investigations

-       SOPs internally and externally

-       Record review and batch release

-       Packaging and labeling

-       Updating the IND

Part 4: Evolving processes to commercialization

-       Quality unit roles and responsibilities

-       Facility updates Change control

-       Preparing for the NDA/BLA

-       Validation plan

-       Master batch record

-       Electronic data collection

-       Packaging and labeling

-       Distribution

-       Instructions for use, storage, and handling

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.

-       Moving a Product out of R&D

-       CMC Requirements for an IND Study and commercial

-       Good Manufacturing Practices: Basics for Beginners

-       Raw Material Management

Specifics topics include:

-       Issues with research grade material used for laboratory and non-clinical testing

-       Optimizing manufacturing processes

-       Raw material requirements and process development

-       Assessing scalability of manufacturing

-       Planning the CMC for a potential IND

-       Study Essential elements of the CMC section of an IND

-       Characterization of the active ingredient and finished product

-       Various kinds of products: drugs, biologics, botanicals, diagnostics, medical device

-       Manufacturing facility personnel equipment and requirements

-       Core principles of GMP regulatory requirements for all different products… drugs to medical devices

-       Customizing regulatory compliance to a given product

-       Role of discussions with the FDA

-       Planning for the early stage with an eye toward large scale manufacturing

-       Vendor management

-       Raw material handling issues for early-stage products

-       Manufacturing step development

The following topics will be discussed to provide the requirements for early-stage products of different types and for vendor selection and management.

-       The scope of the FDA guidance documents

-       Acceptable practices and tips

-       GMP requirements for exploratory clinical studies

-       Specific requirements for drugs, biologics, and combination products

-       Specific issues for various kinds of combination products

-       Combination products with one or more new components

-       CMC issues for 505(b)(2) products

-       GMP and QSR: which to follow for a combination product

-       Introduction to process validation for early-stage manufacturers

-       Step by step introductions for process validation

-       Process validation reports and other documentation

-       Developing SOPs based on validation processes

-       Logistics of using contract manufacturing organizations for early-stage products

-       Pilot scale manufacturing requirements GMP-grade and non-GMP grade manufacturing

Benefits and challenges with using local and international  vendors

Target Industry

Small to midsized businesses (30- 400 employees)

Target Job Title



Supervisors in Regulatory Affairs


Quality Assurance

Clinical Operations

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Training CD-DVD

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

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Recorded video session

Speaker: Peggy J Berry,

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).

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