Quality by Design for Biopharmaceuticals

Parenteral Drug Association Connecting People, Science and Regulation ^®

Quality by Design for Biopharmaceuticals

Jun 12 - Jun 12, 2017 |

Jun 12, 2017 |

Hilton Berlin | Berlin, Germany

Education

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Europe

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The principles and practices of Quality by Design (QbD) for biopharmaceutical, biosimilar, and other biologic manufacturing processes are here now, with regulatory authority expectation for market approval submissions to include at a minimum the quality target product profile (QTPP), identification of critical quality attributes (CQAs) and justification of critical process parameters (CPPs). The principles and practices of QbD are applicable for both in-house and contracted-out biopharmaceutical development, manufacturing and testing.

Unfortunately, there is so much confusion today about what QbD is and isn’t: What is so different about QbD? Must QbD include a thorough multi-variate analysis of design space? Does QbD guarantee regulatory freedom to independently make future manufacturing process changes? Does QbD mean no future manufacturing problems?

Practical suggestions to help your company apply QbD to your biopharmaceutical, biosimilar or other biologic development program will be provided by examining what has worked already for other companies. The six (6) key steps of QbD will be examined and discussed carefully. Also, this course will identify the limitations of the QbD approach.

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Contact

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

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
registration-europe@pda.org
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

845 Euro

All fees given in Euro and excluding VAT (19%)

Contact

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

Hilton Berlin
Mohrenstraße 30
10117 Berlin
Germany
Hotel Website

Hilton Berlin is a 5-star hotel offering a sun terrace, a winter garden and a library. Featuring traditional architecture, the hotel has been open since 1990.

It is located close to the Berlin Cathedral, the Reichstag Dom and the city center, just 1km from the Potsdamer Platz subway station. The hotel is within walking distance of Pergamon Museum, the Concert House Berlin and the shopping malls of Friedrichstraße.

This stylish hotel comprises rooms like Leisure Dome Suite, Hilton Deluxe Hilton Guest Room and Hilton Dome Guest Room with contemporary decor and such comforts as an in-room safe, a minibar, TV, a living space and a CD player. Many rooms come with a captivating view of the cathedral. The airy rooms feature bathrooms with a bathtub, a bidet and free toiletries.

The dining options include a deluxe buffet breakfast served daily. Guests can enjoy exquisite flavors of German meals at the lounge restaurant. The cozy lobby bar features live music, a terrace and free Wi-Fi.

PDA Europe has reserved a limited number of rooms until the 30th April 2017.

Book your room for the PDA Group Rate.

Single Room € 189 per night
Double Room € 209 per night

This hotel provides a shuttle service.

How to Get There

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 6091 1150
Hotel distance: 11.9 km. About 24 to 40 min

Bus & Subway service, fee: 2.7 EUR (one way)
Estimated taxi fare: 25 EUR(one way)

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 6091 1150
Hotel distance: 25.2 km. About 30 to 50 min

Bus & Subway service, fee: 3.3 EUR (one way)
Estimated taxi fare: 40 EUR (one way)

Parking
On-site parking fee, inquire at the hotel desk

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Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

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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.

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