2020 ISPE October 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.   

GMP Auditing for the Pharmaceutical Industry
1 - 2 October 2020

This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities.

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Instructor


Science and Risk-Based Commissioning & Qualification
5 - 6 October 2020

Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning and 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. Applying the QRM C&Q Process Flow, presented in the Guide, topics covered include the principles, activities, and deliverables that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness-for-use/qualification as required by major global regulatory authorities.

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Instructor


GAMP Approach to Data Integrity, Electronic Records and Signatures, and Operations of GxP Computerized Systems
12 - 13 October 2020

This GAMP Data Integrity 21 CFR Part 11 Classroom Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.

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Instructor


Combination Products
13, 15, 20, 22 October 2020

An overview and the intricacies of the GMPs for combination products will be provided that specifically address the challenges and expectations from industry and global regulatory agencies. The development of the basis for the product, testing, and specifications including identifying design inputs, user requirements and design requirements as starting points to the development process will be reviewed in detail.

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Instructor


Aseptic Processing
13 - 16 October 2020

This 2-day course will focus on aseptic processing and quality management around the most important pharmaceutical technology.

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Instructor

Jörg Zimmermann

Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.

GAMP Approach to Data Integrity, Electronic Records and Signatures, and Operations of GxP Computerized Systems
19 - 20 October 2020

This GAMP Data Integrity 21 CFR Part 11 Classroom Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.

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Instructor


Clean in Place Fundamentals
20 - 23 October 2020

This 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.

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Instructor


First Principles to Improve Pharma Manufacturing Operations
26 - 27 October 2020

This course will show how First Principles-based approaches will provide a valuable tool to help create such control strategies. Drawing on examples from over 30 years’ experience in the pharma industry, the attendees will see what First Principles are and how not using a First Principle approach can lead to poor problem solving and even significant disasters. Many activities and exercises will be used to demonstrate the application of First Principles to problem-solving in pharmaceutical manufacturing and engineering.

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Instructor


GAMP® 5, Annex 11/Part 11 Basic
28 - 29 October 2020

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. Please click the "Locations and Registrations" table to select the two or three-day sessions.

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Instructor


Science and Risk-Based Commissioning & Qualification
29 - 30 October 2020

Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning and 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. Applying the QRM C&Q Process Flow, presented in the Guide, topics covered include the principles, activities, and deliverables that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness-for-use/qualification as required by major global regulatory authorities.

Learn More     Register

Instructor

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