ICH Q11- API Manufacturing – 2017

Start Date : June 22, 2017
End Date : June 22, 2017
Time : 10:00 am to11:30 am

Phone : (800) 447-9407
Email : support@compliance4All.com

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

Organized by

Organized by compliance4all14

Compliance4ALL ,
161 Mission Falls Lane, Suite 216,

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .

Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

Tel: 18004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com


Event Categories: Health & Nutrition.

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