2020 ISPE September Online Live Training

Deep Dive into 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 eLearning training options available, ISPE training courses adapt to any schedule or location.   

Pharmaceutical Water Generation
1 - 4 September 2020

This trianing course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.

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Instructor


Basic Principles of Computerized Systems Compliance using GAMP 5, Including Revised Annex 11 & Part 12 Updated!
15 - 16 September 2020

This trianing course includes the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This two day fundamental course* introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.

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Instructor

Michael Byrd

Former Director of CVS and CTO for ProPharma Group
ProPharma Group

Cleaning Validation Principles
21 - 24 September 2020

This training course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication. Additional content includes elements of a cleaning validation program from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes and the establishment of scientific rationales acceptable to regulatory inspectors.

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Instructor


HVAC for Pharma Facilities
23 - 25 September 2020

This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.

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Instructor


 

Practical Implementation of Process Validation Lifecycle Approach 
29 Sept – 1 Oct 2020

This trianing course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System.

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Instructor

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