online webinar 2019 - 6-Hour Virtual Seminar on Phase I GMPs

Overview
Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower 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 less stringent GMPs.
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.
Why you should attend
Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
Who Will Benefit
Directors
Managers
Supervisors in Regulatory Affairs
Manufacturing
Quality Assurance
Clinical Operations
Agenda
Lecture 1 - 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 Manufacuring Practices: Basics for Beginners
Raw Material Management
Specific topics include:
Issues with research greade material used for laboratory and nonclinical 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 eqquipment and requirements
Core principles of GMP regulatory requirements for all different products durgs 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
Lecture 2 - 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
Acceptable practices and tips
GMP requirements for exploratory clinical studies
Specific requirements for drugs, biologic, 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 valiidation processes
Logistics of using contract manufacturing organizations for early stage products
Pilot scale manufacturing requirements GMPgrade and nonGMP grade manufacturing
Benefits and challenges with using local and international vendors
Speaker
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)