How to find the right GMP for APIs

Name: How to find the right GMP for APIs
Start: 2016-06-30
End: 2016-06-30

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

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Europe

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Overview
Agenda
Additional Information
Travel
Registration Fees
Exhibit & Sponsorship
Contact

Program Highlights

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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 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

Who Should Attend

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Travel

PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Sonnenallee 225
Berlin, Germany

How to Get Here

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Directions

Registration Fees

Regular Price

For your credit card information safety: Please send your details by fax only
For an easier registration, please note the helpful hints on the registration form

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 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].

All prices in Euro (EUR)

For your credit card information safety: Please send your details by fax only

For an easier registration, please note the helpful hints on the registration form

Ways to Register

Online Registration
FAX: +49 30 436 55 08 66
[email protected]

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).
Please contact us if you are entiteld to receive a discount

Antje Petzholdt

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

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Exhibition Inquiries

Training Course Inquiries

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

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]