ICH Q11- API Manufacturing - 2017

Website Thiswebinarwilladdressapproachestodevelopingandunderstandingthemanufacturingprocessforadrugsubstance | Edit Freely

Category 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

Deadline: June 21, 2017 | Date: June 22, 2017

Venue/Country: Online, U.S.A

Updated: 2017-04-24 18:49:40 (GMT+9)

Call For Papers - CFP

Overview:

This course will show how psychological factors enter into the engineering profession. Many aspects of the engineering profession are nontechnical such as balancing "green" practices with an effective cost structure, engineering ethics, how detail oriented should an engineer be, employee mental fitness for work, manager's leadership style, and communication between engineers.

Why should you Attend:

A project will suffer if there is not an understanding of the personality types of the workers involved. This can make the difference between a successful project and one that fails. Without some understanding of psychological inevitable conflicts will arise.

Areas Covered in the Session:

Safety Analysis Considering Human Error

Human Factors Engineering

Behavior Based Safety Analysis

Steps toward Human Performance Improvement

Work/Life balance in the Engineering Profession

Crisis Decision Making

Mentoring

Who Will Benefit:

Project Managers

Executives

Engineers

Architects

Psychologists

Counselors

Speaker Profile:

Keith Warwick , PE earned a B.S. in Civil Engineering from the University of California at Davis. He became a California Professional Engineer in 1983 and has also held PEs in Indiana, Tennessee, Illinois and New York. He has 34 years of civil, environmental and safety engineering experience.

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: supportcompliance4All.com