ISPE In Person Training Courses

ISPE Online Live Training Courses


Process Validation (T46) Training Course

Submitted by Anonymous on Mon, 01/16/2023 - 09:30
Date
-

Dublin, Ireland
Ireland

Training Course
This training 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.

Custom C&Q (T40) Training Event for Singapore Affiliate

First name
Trudy
Last name
Patterson
Submitted by Trudy Patterson on Wed, 05/03/2023 - 13:37
Date
-

%locality, Singapore
Singapore

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.

Science and Risk-based C&Q (T40)

Submitted by Anonymous on Tue, 01/10/2023 - 15:30
Date
-

Las Vegas, NV, United States
United States

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.

Basic GAMP5 & Part 11 - T07

Submitted by Anonymous on Thu, 01/12/2023 - 15:30
Date
-

Las Vegas, NV, United States
United States

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, by building upon existing industry good practice in an efficient and effective manner.

GAMP® Data Integrity 21 CFR Part 11 (T70)

Submitted by Anonymous on Thu, 01/12/2023 - 15:30
Date
-

Las Vegas, NV, United States
United States

Training Course
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This 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 to ensure the integrity and validity of the information throughout the data lifecycle.

Overview of Biopharmaceutical Manufacturing Processes

Submitted by Anonymous on Tue, 01/10/2023 - 16:30
Date
-

Barcelona, Spain
Spain

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.