Date :
Place : United States, Aurora
Website :https://bit.ly/2HNKqpm
Contact Person:Training Doyens
Description:
OVERVIEW This program 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. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed. WHY SHOULD YOU ATTEND This presentation is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing. AREAS COVERED • Manufacturing process development • Process controls • Selection of starting materials • Control strategy • Process validation evaluation • Submission of information • Life cycle management LEARNING OBJECTIVES By the end of this program, attendees will understand the requirements of the Q11 guidance and learn skills for practical implementation of those requirements. WHO WILL BENEFIT • Quality Assurance • Quality Control (Chem and Micro) • Process and Design Engineering • Process Automation • Manufacturing Operations • Validation • Utility Operations • Regulatory Affairs For more detail please click on this below link: https://bit.ly/2IYbQFR Email: [email protected] Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882Deadline for abstracts/proposals : 18th May 2018
Organized By :Training Doyens
Keynote Speakers : 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 an
Venue :Training Doyens, Aurora, CO, United States
Check the event website for more details.