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 Should you 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:
• Supervisors in Regulatory Affairs
• Quality Assurance, and Clinical Operations
Day 1 Schedule
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
Specificic topics include:
• Issues with research greade 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 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
Day 2 Schedule
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 GMP-grade and non-GMP grade manufacturing
• Benefits and challenges with using local and international vendors
Jim Sheldon Dean
Director of Compliance Services, Lewis Creek Systems, LLC
Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a wide variety of health care entities.
Sheldon-Dean serves on the HIMSS Information Systems Security Workgroup, has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup, and is a recipient of the WEDI 2011 Award of Merit. He is a frequent speaker regarding HIPAA and information privacy and security compliance issues at seminars and conferences, including speaking engagements at numerous regional and national healthcare association conferences and conventions and the annual NIST/OCR HIPAA Security Conference in Washington, D.C.
Sheldon-Dean has more than 30 years of experience in policy analysis and implementation, business process analysis, information systems and software development. His experience includes leading the development of health care related Web sites; award-winning, best-selling commercial utility software; and mission-critical, fault-tolerant communications satellite control systems. In addition, he has eight years of experience doing hands-on medical work as a Vermont certified volunteer emergency medical technician. Sheldon-Dean received his B.S. degree, summa cum laude, from the University of Vermont and his master’s degree from the Massachusetts Institute of Technology.
Location: Philadelphia, PA Date: April 16th & 17th, 2019 and Time 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Philadelphia Airport, 4509 Island Avenue, Philadelphia, PA 19153
1 ATTENDEE $2,000, Regular Price: $2000, Register for 1 attendee
5 ATTENDEES $10,000, Regular Price: $10,000, Register for 5 attendees
10 ATTENDEES $20,000, Regular Price: $20,000, Register for 10 attendees
Until March 10, Early Bird Price: $2,000. From March 11 to April 12, Regular Price: $2,200.
Use this promo code GCP50 to get 50% off.
Sponsorship Program benefits for seminar
For More Information- https://www.globalcompliancepanel.com/control/sponsorship
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