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Webinar:

Recommendations on how to implement ICH Q9 and Q10

 

Industry field:

Pharmaceutical industry

 

Webinar description:

Quality Systems and Quality Risk Management is relatively new to the pharmaceutical industry. Guidances have been published from the regulators and EMEA is currently working on revisions of EU GMP Part 1 to incorporate the Q10 principles. This webinar will give you ideas and recommendations on how to start and what to consider.

 

The Webinar is a 2 hour session with the two speakers on-line and there will be time to interact for Questions and Answers.

 

Content:

  • Introduction – background to ICH Guidances on Pharmaceutical Quality Systems (Q10) and Quality Risk Management (Q9)

  • Practical approaches on how to implement a Quality System as a complement to GMP

    • Experiences from ISO 9001-certification in a GMP environment

  • Recommendations on ways to implement procedures and records for Quality Risk Management

    • Where to begin and what steps to take

Who should attend:

QA/QC managers and manufacturing management within the dosage form and the API industry that needs a deeper understanding of the practical aspects of the implementation of Q9 and Q10 Guidelines from ICH. Participants need to be familiar with the GMP regulations and the ICH documents and have prior experience of the GMP environment.

 

» Registration

» Registration

 

Course facts

Course No:

4812
Speakers:

» Dr. Per Hyldebrink Damgaard,

   Novo Nordisk A/S

» Anna Lundén, Lundén/Ellow ab
Next course:

May 17 2010, 14.00-16.00
Need for equipment:

You need a computer with internet access and audio equipment (speakers or head set). We use Netviewer's communication software that is very easy to use.

Instructions are enclosed with the course confirmation.
Agenda:

14.00-16.00

Price:

€ 195 incl. course material (PDF)
Discounts:

We do not offer any general discounts. Instead we will always offer best value courses for good value fees to ALL our attendees. For larger groups we can offer discounts based on case by case discussions, please contact for quotation. We do not offer or practise any general company discounts without commitments and/or written agreements.
Cancellation policy:

Registration is binding. Cancellations later than 24 hours before the webinar are subjected to a 50% service charge of the course fee. Substitution is always possible and preferred, but please inform us the name of the substituting person before the webinar starts.