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Site language : English - Français
Ref : 25300
Event :ICH Q11- API Manufacturing - 2017

Date :Thursday June 22nd, 2017

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

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

Further information

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Announcer

Compliance4All
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 [...]

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Details

ICH Q11- API Manufacturing - 2017 Pharmacy - Medicine
manufacturing process, development, quality, drugs webinars, process automation, regulatory affairs, manufacturing operations, life cycle management
Professionals, Quality Assurance Quality Control (Chem and Micro) Process and Design Engineering Process Automation Manufacturing Operations Validation
100 1 --
English

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