GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

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Virtual Seminar on Phase I GMPs

Start Date : February 8, 2019
End Date : February 8, 2019
Time : 8:00 am to11:00 am

Phone : (800) 447-9407
Email : globalcompliancepanel@gmail.com

Description

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


 



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). 

Organized by

Organized by globalcompliancepanel

Netzealous LLC DBA - Globalcompliancepanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

Tel: 18004479407
Email: globalcompliancepanel@gmail.com
Website: www.globalcompliancepanel.com


Event Categories: Health & Nutrition.




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