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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
Cancelled
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.

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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.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD

How to Get Here

By Air

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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 info@pda.org 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: ko@pda.org

* 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 registration@pda.org 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 registration@pda.org. Phone messages are not accepted.

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Training Course Inquiries

Tel: +1 (301) 656-5900
TRI@pda.org

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

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Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

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