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How to find the right GMP for APIs

Jun 30, 2016
Berlin, Germany

This course will provide practical guidance of key aspects laid down in the ICH Q7 guideline. It will clarify and layout the appropriate GMP standard to be applied by API manufacturers.

  • Education
  • Europe
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Overview

It was an enormous success that the API manufactures have received their own GMP guideline by ICH because there are significant differences between the GMP requirements for Drug (Medicinal) Products and APIs.

This course will provide practical guidance of key aspects laid down in the ICH Q7 guideline. It will clarify and layout the appropriate GMP standard to be applied by API manufacturers. In particular it will address GMP related topics of quality, production, logistic, engineering and biotechnology.

It is a unique chance to receive first-hand knowledge, interpretation and understanding of ICH Q7 and to ask questions to one of the ICH Q7 authors.

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Agenda

  • Contact

    Elke von LaufenburgElke von Laufenberg 
    Manager Training & Education
    Tel: +49 (0) 30 43 655 08-21
    Fax: +49 (0) 30 43 655 08-66
    Email

Additional Information

  • Learning Objectives

    Learning Objectives

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  • Who Should Attend

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Travel

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Sonnenallee 225
Berlin, Germany

How to Get Here

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Directions

Registration Fees

Regular Price

4 Ways to register

  • Online Registration
  • FAX: +49 30 436 55 08 66
  • [email protected]
  • Mail: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

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All Participants

695 Euro

All fees given in Euro and excluding VAT (7%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0)30 43 655 08-10
Fax: +49 (0)30 43 655 08-66
Email

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

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Tel: +1 (301) 656-5900 ext. 115
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