Course offering number:0904-704
Course ID:
2284
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Implementing GEP (Good Engineering Practices) in the Pharmaceutical, Bio-Pharmaceutical, and Medical Device Industries
In Conjunction With Wiley-Blackwell
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is intended for Engineering Unit Managers and interdisciplinary Project Team Members who are responsible to deliver “Fit for Intended Use” cGMP manufacturing, R&D, and supporting facilities. The course is recommended for:
• Engineering Managers
• Project Managers
• Quality Unit Managers
• Commissioning & Qualification Project Team Leaders
• Engineering Design Service Providers
• Construction Managers
• Compliance Service Providers
Description
This 90-minute accredited online course is aligned with current industry “Risk-Based” initiatives and guidance provided in ICH Q9, ASTM E2500, and ISPE Baseline & Good Practice Guides. This course will provide insight on critical project decision making and enable a project team to identify and document data during the application of GEPs during the design, specification, and verification phases of a project. Discussions will focus on identifying and implementing Engineering Quality Systems to assure efficiency and quality.
Module 1:
• GEP Overview
• Engineering Quality Systems
• GMP and GEP
Module 2:
• Design Review Process
• Change Management
• Risk Management
Module 3:
• Applying GEP to the Verification (Commissioning
& Qualification)
• Integrating the Project and Engineering Lifecycles
• Planning for Success
Question and Answer Session
Other Courses of Interest
Applied cGMPs for Pharmaceutical and Allied Industries
Biopharmaceutical Process Systems
Commissioning, Qualification and Validation
Critical Process Cleaning and Cleaning Validation
Feb 27 2012, Amsterdam, The Netherlands
Critical Process Cleaning and Cleaning Validation
Mar 26 2012, New Brunswick, NJ
IQ, OQ, PQ
Mar 13 2012, New Brunswick, NJ
IQ, OQ, PQ
May 14 2012, Amsterdam, The Netherlands
Pharmaceutical Process Development
Apr 23 2012, Amsterdam, The Netherlands
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Feb 27 2012, New Brunswick, NJ
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Jun 11 2012, Amsterdam, The Netherlands