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2024 EDQM Virtual Training Program

EDQM Virtual Training Program

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aksshiny
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38 views2 pages

2024 EDQM Virtual Training Program

EDQM Virtual Training Program

Uploaded by

aksshiny
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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2024 EDQM VIRTUAL TRAINING PROGRAMME

Independent modules on the Ph. Eur.,


reference standards and the CEP Procedure
(CHEMICALLY DEFINED ACTIVE SUBSTANCES)

Week 1 - Programme

Monday, 2 December - Module 1: General methods, general chapters and general


monographs (live webinar)
Duration: 1 hour 30 mins
10:00-11:00 General methods, general chapters and general monographs
11:00-11:30 Live Q&A Session

Tuesday, 3 December - Module 2: Individual monographs - Focus on chemically


defined active substances and medicinal products containing chemically defined
active substances (live webinar)
Duration: 1 hour 30 mins
10:00-10:30 Individual monographs for chemically defined active substances
10:30-11:00 Individual monographs for medicinal products containing chemically defined active substances
11:00-11:30 Live Q&A Session

Thursday, 5 December June - Module 3: Impurity control in the Ph. Eur. (live
webinar)
Duration: 1 hour 30 mins
10:00-11:00 Impurity control in the Ph. Eur.: theory and practical examples
11:00-11:30 Live Q&A Session

Friday, 6 December - Module 4: Ph. Eur. reference standards (live webinar)


Duration: 2 hours 10 mins
10:00-10:40 Ph. Eur. Reference Standards: establishment and use
10:40-10:50 What GMP inspectors expect concerning RS
10:50-11:40 Handling, dispatch, where to find useful information and other practicalities
11:40-12:10 Live Q&A Session

***
2024 EDQM VIRTUAL TRAINING PROGRAMME

Independent modules on Ph. Eur.,


reference standards and CEP Procedure
(CHEMICALLY DEFINED ACTIVE SUBSTANCES)

Week 2 - Programme

Monday, 9 December - Module 5: Fundamentals of the CEP Procedure (live


webinar)
Duration: 1 hour 45 mins
10:00-10:30 General overview of the CEP Procedure
10:30-11:15 Use of a CEP
11:15-11:45 Live Q&A Session

Tuesday, 10 December - Module 6: Building successful CEP dossiers (live


webinar)
Duration: 1 hour 30 mins
10:00-11:00 How to build a good new CEP application
11:00-11:30 Live Q&A Session

Tuesday, 10 December - Module 7: Building successful CEP revision applications


(live webinar)
Duration: 1 hour 30 mins
14:30-15:30 How to build a good CEP revision application
15:30-16:00 Live Q&A Session

Thursday, 12 December - Module 8: Control of impurities: CEP approach (live


webinar)
Duration: 1 hour 30 mins
10:00-11:00 Control of impurities: CEP approach
11:00-11:30 Live Q&A Session

Friday, 13 December- Module 9: The EDQM inspection programme (live webinar)


Duration: 2 hours
10:00-11:00 Introduction to the EDQM inspection programme
11:00-11:30 How to prepare for an inspection – Most common GMP deficiencies
11:30-12:00 Live Q&A Session

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