GMP Fundamentals Bundle Series - Limited Offer

ISPE Online Live Training Courses

ISPE Online Live Training Courses


Submitted by Anonymous on
GMP Fundamentals for the Pharmaceutical Industry (G01)
Date
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Training Course
This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process.
Submitted by Anonymous on
GAMP® 5, Annex 11/Part 11 Basic Principles (T45)
Date
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Training Course
This 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.
Submitted by Anonymous on
Overview of Biopharmaceutical Manufacturing Processes (T24)
Date
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Training Course
This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins.
Submitted by Anonymous on
GAMP® 5 GxP Process Control (T21)
Date
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Training Course
This highly interactive classroom course describes how the GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Process Control Systems, and GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records  may be applied to achieve process control systems that are fit for intended use, incorporate data integrity and meet current regulatory requirements.
Submitted by Anonymous on
GAMP® Data Integrity 21 CFR Part 11 (T50)
Date
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Training Course
This GAMP Data Integrity 21 CFR Part 11 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.
Submitted by Anonymous on
Storage Delivery and Qualification of Pharmaceutical Waters
Date
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Training Course
This course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The 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, laboratory water and rouging.
Submitted by Anonymous on
PAI Readiness
Date
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Online Live, United States
United States

Training Course
This new training course on the elements necessary to ensure readiness for pre-approval inspections provides strategy and tactics towards preparation than can be customized to individual organization requirements.
Submitted by Anonymous on
Science and Risk-based C&Q (T40)
Date
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Training Course
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. 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.
Submitted by Anonymous on
HVAC for Pharma Facilities
Date
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Training Course
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.