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Process Validation for Biotechnological Products - EU edition MasterClass

Process Validation for Biotechnological Products - EU edition MasterClass

22 - 23 November, 2022

Online Event

Process Validation for Biotechnological Products MasterClass aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production....

  • +4 months
Pharmaceutical Reference Standards - EU edition MasterClass

Pharmaceutical Reference Standards - EU edition MasterClass

22 - 23 November, 2022

Online Event

Reference standards are an essential tool in the quality control of APIs (active pharmaceutical ingredients), excipients and medicinal products. They may be obtained from official sources or may, under certain circumstances, be developed and maintained in-house. In this training course you will learn about the correct use of official (pharmacopoeial) standards and regulatory requirements but also about the possiblity to establish in-house standar...

  • +4 months
Cross-contamination Risk Assessment in Pharmaceutical Manufacturing - EU edition MasterClass

Cross-contamination Risk Assessment in Pharmaceutical Manufacturing - EU edition MasterClass

21 - 22 November, 2022

Online Event

It is common practice in the Pharmaceutical Industry to manufacture multiple drug products in shared facilities with shared equipment. To avoid cross-contamination, all surfaces with product contact are cleaned prior to manufacturing of the subsequent product. According to current EU GMP requirements, the cleaning process has to be validated taking into account the API specific PDE (“Permitted Daily Exposure”) values. The EMA “Guideline on ...

  • +4 months
GAMP® 5 - US edition MasterClass

GAMP® 5 - US edition MasterClass

21 - 22 November, 2022

Online Event

In this Master Class, we will review the current trends, including in technology and in FDA compliance and enforcement. We’ll look at Data Integrity, 21 CFR Part 11 (Electronic Records/Electronic Signatures), European Union (EU) Annex 11, General Data Protection Regulation (GDPR), and other regulatory requirements....

  • +4 months
Entry Level CMC - US edition MasterClass

Entry Level CMC - US edition MasterClass

21 - 22 November, 2022

Online Event

Chemistry, Manufacturing and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics....

  • +4 months
Basic Principles of Computerized Systems Compliance Using GAMP® 5 Version 2 - EU edition MasterClass

Basic Principles of Computerized Systems Compliance Using GAMP® 5 Version 2 - EU edition MasterClass

21 - 22 November, 2022

Online Event

With modern facilities, installations, and equipment, PLCs and computers are an integral part of such systems. More often than not PLCs and computers are considered autonomous systems and handled separately within the QMS and protocols. In this two-day course, we will look at Basic Principles of Computerized Systems Compliance using ISPE’s GAMP5 Version 2 industry guidelines, compared to FDA’s Title 21 CRF Part 11 regulations, and EU’s Eudr...

  • +4 months