ICH Q11- API Manufacturing - 2017

Fremont (United States), 22 June 2017


Key deadlines
Conference starts:
2017-06-22
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Conference Description

Overview:
This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application.

Why should you Attend:
This presentation is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty.

Areas Covered in the Session:
Manufacturing process development
Process controls
Selection of starting materials
Control strategy
Process validation evaluation
Submission of information
Life cycle management

Who Will Benefit:
Quality Assurance
Quality Control (Chem and Micro)
Process and Design Engineering
Process Automation
Manufacturing Operations
Validation
Utility 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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Full Details & Registration Link:
http://www.compliance4all.com/control/w_product/~product_id=501245LIVE?channel=confroll_Jun_2017_SEO

Conference creator: compliance4all

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Conference Location

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161 Mission Falls Lane, Suite 216,,
Fremont 94539 (United States)

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