GMP Fundamentals Bundle Series - Limited Offer

ISPE Online Live Training Courses

ISPE Online Live Training Courses


Submitted by Anonymous on
Aseptic Processing & Annex 1 Training Course (T63)
Date
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Training Course
This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.
Submitted by Anonymous on
Biopharmaceutical Manufacturing Facilities (T31)
Date
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Training Course
This 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.
Submitted by Anonymous on
Quality Risk Management (T42)
Date
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United States
United States

Training Course
This interactive advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.
Submitted by Anonymous on
Pharma Facilities Project Management (T26)
Date
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Online Live, United States
United States

Training Course
Specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment.
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.