2019 ISPE Durham In-Depth Pharma Training Series

Deep Dive Pharma Training Courses 

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 classroom, eLearning and onsite training options available, ISPE training courses adapt to any schedule or location.   

Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles

3-4 June 2019

This classroom training course in biopharmaceutical manufacturing facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products.

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Robert Warn
Principal Engineer
Commissioning Agents Inc
Instructor

Robert Warn is a Senior project manager and Principal Engineer at Commissioning Agents Inc., with over 14 years in the biotechnology industry. He has extensive project management, process engineering, commissioning, qualification and process validation experience on biotechnology manufacturing systems and equipment. His expertise are focused on process tech-transfer and manufacturing equipment implementation. As well, Robert has consulted on implementing PPQ and C&Q programs for his clients. Robert has a mechanical engineering background and is a current member of the ASME Bioprocessing Equipment (BPE) Standards Committee.


Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

3-4 June 2019

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. 

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Steven J. Wisniewski
Principal Compliance Consultant
CAI
Instructor

Steven Wisniewski is Principal Consultant for CAI Consulting, a highly respected provider of consulting and technical services for biotech and pharmaceutical manufacturers worldwide. CAI Consulting focuses on the manufacturing lifecycle process, with services including commissioning, validation, technology transfer, owner Project Management, maintenance programs, SOPs, training and cGMP compliance. Wisniewski has more than 35 years’ experience in the pharmaceutical, biotech, and device industries.