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ICH Q11- API Manufacturing - 2017

Event Details

ICH Q11- API Manufacturing - 2017

Time: June 22, 2017 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: 18004479407
Event Type: webinar
Organized By: Adam Fleaming
Latest Activity: on Friday

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Event 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

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