FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials: 2-Day In-Person Seminar by Ex-FDA Official (San Francisco, CA - August 21st-22nd, 2018) - ResearchAndMarkets.com

May 14, 2018

DUBLIN--(BUSINESS WIRE)--May 14, 2018--The “FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials: 2-Day In-Person Seminar by Ex-FDA Official” conference has been added to ResearchAndMarkets.com’s offering.

Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.

The following steps to establish the appropriate manufacturing environment for phase 1 investigational drugs should be taken:

A comprehensive and systematic evaluation of the manufacturing setting (i.e., product environment, equipment, process, personnel, materials) to identify potential hazards Appropriate actions prior to and during manufacturing to eliminate or mitigate potential hazards to safeguard the quality of the phase 1 investigational drug

Review the FDA recommendations and requirements for implementing a compliant program for the phase 1 clinical program.

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.

Overview of Good Manufacturing Practices GMP Requirements for a Phase 1 Study PersonnelQC FunctionFacility and EquipmentControl of components, containers and closuresManufacturing & RecordsLaboratory Controls Vendor selection & management Process Validation Special Considerations Multi-product facilitiesBiologicsSterile productsCombination products Providing relevant information in the IND application Course benefit:

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.

Learning Objectives:

To gain an understanding of the requirements for drugs entering into phase 1 clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing manufacturing and quality strategies to meet FDA requirements.

Areas Covered:

Day 1 Topics

Overview of GMP requirementsGMP Requirements for a Phase 1 StudyPersonnel documentation and requirementsQC Function procedures and requirementsFacility and Equipment requirementsControl of components, containers and closures - methods and specsManufacturing & Records during phase 1 studies with an eye toward later development

Day 2 Topics

Vendor selection & managementProcess Validation to conduct for phase 1 clinical supply processSpecific requirements for various types of products: biologics, combinations, sterile productsMulti-product facilities considerationsPreparing relevant SOPs for early stage developmentProviding relevant information in the IND application

For more information about this conference visit https://www.researchandmarkets.com/research/kn69tg/_fdas_gmp?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20180514006194/en/

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Related Topics:Clinical Trials



SOURCE: Research and Markets

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PUB: 05/14/2018 02:28 PM/DISC: 05/14/2018 02:28 PM


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