HEALTHCARE 2021 - 6-Hour Virtual Seminar on Phase I GMPs

Website https://www.compliance4alllearning.com/webinar/6-hour-virtual-seminar-on-phase-i-gmps-503618LIVE | Edit Freely

Category HEALTHCARE 2021

Deadline: April 01, 2021 | Date: April 01, 2021

Venue/Country: Online Event, U.S.A

Updated: 2021-03-09 20:34:44 (GMT+9)

Call For Papers - CFP

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.

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

Who Will Benefit:

Directors

Managers

Supervisors in Regulatory Affairs

Manufacturing

Quality Assurance

Clinical Operations

Speaker Profile

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).