New ICH & EMA Quality Guidelines

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

New guidelines are elaborated and established guidelines have to be revised to take into account the scientific and technological progress in the pharmaceutical industry. The ICH Q12 Guideline is currently in the international implementation phase and will impact massively product development, dossier preparation, variations and product transfer activities. ICH Q14 has been drafted to set standards for the development of analytical methods and is closing a gap which has been opened with the implementation of ICH Q8 Pharmaceutical Development. As a consequence, the old ICH Q2 Guideline on Analytical Validation had to be revised taking into account new analytical techniques
and their validation. Continuous manufacturing is increasingly implemented for high volume pharmaceutical manufacturing and after almost 10 years lack of clarity what documents will be required by the authorities and how process validation should be designed, the ICH Q13 draft provides guidance to industry and authorities.

For companies active in the EU, it is important to closely follow up the publications of the EMA.
In summary, this course will help the delegates to identify important new GMP and Regulatory aspects which should be considered throughout the entire life cycle of their specific products and avoid waste of time and money, thereby.

meet the training leader
Dr. Helmut Vigenschow
Senior pharmaceutical consultant and Founder
ViPharmaService
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

New ICH & EMA Quality Guidelines online live training Fleming Agenda Cover
New ICH & EMA Quality Guidelines online live training Fleming Agenda Cover
New ICH & EMA Quality Guidelines online live training Fleming Agenda Cover
key training

Topics

ICH Q12 Lifecycle Management

ICH Q13 Continuous Manufacturing

EMA Guideline on quality documentation for medicinal products when used with a medical device

ICH Q14 Analytical Procedure Development

ICHQ2(R2) Analytical Validation

Current EMA Quality Discussions and Initiatives

Benefits of attending

Testimonials

FROM OUR PHARMA training
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This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

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