Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.
Real World Practice: Courses present exercises that use current problems and situations common to the industry.
Experienced Instructors: Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
Global Training to Fit Your Needs: With eLearning
Science and Risk-based Commissioning and Qualification 6 - 9 May 2024
Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
This online course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control and laboratory water as well as key design philosophies.
Turning Quality by Design (QbD) into a Practical Reality 13 - 16 May 2024
Substantial business benefits are emerging from industry when Quality by Design (QbD) principles are used for new and existing drug products yielding reduced operating costs, enabling significantly more efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations.
This new course is focused on how to be compliant in the design, operation & qualification of critical utilities and how to prove it. It comprises four modules including interactive case studies from real experience. This helps the participants to experience live discussions on compliance topics. The content is primarily based on the new ISPE Good Practice Guide “Critical Utilities GMP Compliance”. All content is held by contributing authors of the Good Practice Guide, so the participants get first-hand information from well-experienced trainers.
Globally supplying companies, which deliver drugs to Europe, must comply with this new regulatory requirement. There is an impact for all stakeholders of manufacturing, across hierarchy levels and various functions at manufacturers. Also, suppliers have to consider Annex 1 when supplying new equipment or installing new production facilities.
Biotechnology Manufacturing Facility Design 21 - 24 May 2024
The course includes a review of biopharmaceutical manufacturing facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy. Participants will discuss current case studies on a wide array of facility topics, and complete class exercises that involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements.