Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process; producing high quality products and consistent operation to meet product user requirements. Guidance on the transition of an organization’s approach to Commissioning and Qualification to one that incorporates a science and risk-based approach will be discussed.
This course was developed by members of the ISPE Commissioning and Qualification COP .
Immediately apply the course objectives using the complimentary copy of the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification.
NOTE: It is strongly recommended that participants be familiar with basic concepts of commissioning and qualification prior to attending this course.
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E2500-07 ensures GMP facilities and equipment are "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. This webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle.
This training course is of particular interest to existing and future members of the following ISPE Communities of Practice (COP):
ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.
Building a Culture of Continuous Improvement & Quality Assurance
Tuesday, 28 Jun 2016 18.06
Double Your Education Opportunities in Process Validation
Monday, 27 Jun 2016 14.06
FDA Office of Pharmaceutical Quality Initiatives & 2016 Priorities
Friday, 24 Jun 2016 12.06