FDA's GMP Expectations 2017 - FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials 2017

Course "FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
Why should you attend:
To gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing phase I manufacturing strategies to meet FDA requirements.
Areas Covered in the Session:
Seminar Day 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
? Good Manufacturing Practices: Basics for Beginners
? Raw Material Management
Seminar Day 2
The following topics will be discussed to provide the requirements for early stage products of different types and for vendor selection and management.
? GMPs for Phase 1 IND products
? GMPs for Combination Products and 505(b)(2) Products
? Process Validation for Early Stage GMP
Outsourcing Early Stage Manufacturing
Agenda:
Day 1 Schedule
Lecture 1:
Issues with research grade material used for laboratory and non-clinical testing
Lecture 2:
Optimizing manufacturing processes
Lecture 3:
Raw material requirements and process development
Lecture 4:
Assessing scalability of manufacturing
Lecture 5:
Planning the CMC for a potential IND
Lecture 6:
Study Essential elements of the CMC section of an IND
Lecture 7:
Characterization of the active ingredient and finished product
Lecture 8:
Various kinds of products: drugs, biologics, botanicals, diagnostics, medical devices
Lecture 9:
Manufacturing facility, personnel and equipment requirements
Lecture 10:
Core principles of GMP Regulatory requirements for different products: drugs to medical devices
Lecture 11:
Customizing regulatory compliance to a given product
Lecture 12:
Role of discussions with the FDA
Lecture 13:
Planning for the early stage with an eye towards large scale manufacturing
Lecture 14:
Vendor management
Lecture 15:
Raw material handling issues for early stage products
Lecture 16:
Manufacturing step development
Day 2 Schedule
Lecture 1:
The scope of the FDA guidance document
Lecture 2:
Acceptable practices and practical tips
Lecture 3:
GMP requirements for exploratory clinical studies
Lecture 4:
Specific requirements for drugs, biologics and combination products
Lecture 5:
Specific issues for various kinds of combination products
Lecture 6:
Combination products with one or more new components
Lecture 7:
CMC issues for 505(b)(2) products
Lecture 8:
GMP and QSR: which to follow for a combination products
Lecture 9:
Introduction to process validation for early stage manufacturers
Lecture 10:
Step by step instructions for process validation
Lecture 11:
Process validation reports and other documentation
Lecture 12:
Developing SOPs based on validation processes
Lecture 13:
Logistics of using contract manufacturing organizations for early stage products
Lecture 14:
Pilot scale manufacturing requirements GMP-grade and non-GMP grade manufacturing
Lecture 15:
Benefits and challenges with using local and international vendors
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).
Location: Los Angeles, CA Date: May 11th & 12th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Four Points by Sheraton Los Angeles International Airport
Address: Four Points by Sheraton Los Angeles International Airport 9750 Airport Boulevard, Los Angeles, CA, 90045, United States
Price:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until April 10, Early Bird Price: $1,295.00 From April 11 to May 9, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
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