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Quality by Design (QbD) for Biopharmaceuticals - A Practical Approach

Aug 23, 2018
Bethesda, MD

This course will discuss the importance and underlying principles of an effective QbD approach for biopharmaceuticals.

  • Education
Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

Overview

The principles and practices of Quality by Design (QbD) for biopharmaceutical manufacturing processes are here now, with regulatory authority expectation for market approval submissions to include at a minimum the quality target product profile (QTPP), critical quality attributes (CQAs) and critical process parameters (CPPs).

Unfortunately, there is so much confusion today about what QbD is and isn’t. What is so special about QbD? Does QbD guarantee regulatory freedom to make future manufacturing process changes? Does QbD mean no future manufacturing problems? Does QbD really pay off for recombinant protein or monoclonal antibody products? Does QbD make sense for genetically engineered viruses and/or genetically engineered cell medicines?

Before launching into QbD, biopharmaceutical manufacturers must first have a firm understanding of the unique challenges facing all biopharmaceuticals, and then a thorough understanding of the International Council on Harmonization (ICH) strategic guidances (Q8, Q9, Q10) for this enhanced approach.

Practical suggestions to help your company apply QbD to your recombinant protein, monoclonal antibody, biosimilar, or gene therapy 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.

Who Should Attend

This course is designed specifically for those involved in or interested in an enhanced control system for biopharmaceuticals, including Senior Management, Directors and Managers/Supervisors, QA/QC, Regulatory Affairs, Manufacturing and Process Development personnel.

Agenda

  • Upon completion of this course, you will be able to:

    • Explain the importance and underlying principles of an effective QbD approach for biopharmaceuticals
    • Apply the principles of QbD to all types of biopharmaceuticals – recombinant proteins, monoclonal antibodies, biosimilars, and gene therapy products

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

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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.

PDA Training and Research Institute

4350 East West Highway
Bethesda, MD

How to Get Here

By Air

More information coming soon.

By Car

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Other Options

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Directions

Registration Fees

Regular Price

Standard

Member

On or before July 6, 2018
$1,192

After July 6, 2018
$1,325

Nonmember

On or before July 6, 2018
$1,431

After July 6, 2018
$1,590


Government/Health Authority/Academic

Member

$795

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by July 23, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: [email protected]

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Contact

Program Inquiries
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]

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