ISPE Online Live Training Courses

ISPE Online Live Training Courses


Submitted by Anonymous on Fri, 10/28/2022 - 15:30
GAMP® 5, Annex 11/Part 11 Basic Principles (T45)
Date
-

Online Live, Belgium
Belgium

Training Course

GAMP® Basic Principles 3-Day 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 Fri, 10/28/2022 - 15:30
Pharmaceutical Water Systems (T35)
Date
-
Training Course

Pharmaceutical Water Systems

This 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 microbial control and laboratory water as well as key design philosophies. 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, EP and non-compendial waters will be covered.
Submitted by Anonymous on Fri, 07/14/2023 - 14:00
GAMP® Data Integrity 21 CFR Part 11 (T50)
Date
-
Training Course

GAMP® Data Integrity 21 CFR Part 11, 3-Day 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.
First name
Trudy
Last name
Patterson
Submitted by Trudy Patterson on Thu, 08/31/2023 - 14:44
Science and Risk-based C&Q (T40)
Date
-

Online Live, United States
United States

Training Course

Commissioning and Qualification 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 Fri, 07/14/2023 - 14:00
GAMP® 5, Annex 11/Part 11 Basic Principles (T45)
Date
-

Online Live, United States
United States

Training Course

GAMP® Basic Principles 3-Day 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 Wed, 08/02/2023 - 14:00
HVAC for Pharma Facilities (T14)
Date
-

Online Live, United States
United States

Training Course

HVAC & Environmental Control for Life Science Facilities 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.
Submitted by Anonymous on Tue, 07/25/2023 - 14:00
Pharma Facilities Project Management (T26)
Date
-
Training Course

Pharma Facilities Project Management 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 Tue, 07/25/2023 - 14:00
Oral Solid Dosage Forms (T10)
Date
-
Training Course

Oral Solid Dosage Manufacturing Process Training Course

This training course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and GMP inspection preparation, and provides guidance on advanced asset lifecycle management strategy.
Submitted by Anonymous on Tue, 07/25/2023 - 14:00
Cleaning Validation Principles (T17)
Date
-
Training Course

Cleaning Validation Principles Training Course

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.
Submitted by Anonymous on Tue, 07/25/2023 - 14:00
Biopharmaceuticals: CMC Aspects (T67)
Date
-

Online Live, United States
United States

Training Course

Biopharmaceuticals: CMC Aspects

This instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. An emphasis will be placed on using Quality by Design principles to develop, manufacture and guide the product lifecycle. Lastly, we will examine biosimilars and regulatory factors that affect product development and the product lifecycle and drug costs.