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Development and Implementation of Qualification and Validation Protocols - A Risk and Science Based Approach

Oct 30 - Oct 31, 2018
Bethesda, MD

  • Education
Cancelled
Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

Overview

Regulatory compliance and business success require establishing and demonstrating confidence in the control of processes related to product quality and patient safety. Product quality must be predictable, processes must be effective, and the systems which support those processes must be reliable.

The understanding of process related hazards and relative risks are essential for efficient and effective qualification and validation of manufacturing systems and processes. The objective of this course is to provide a basis by which the participant can develop and implement risk and science based approaches, as well as integrate and maintain programs, to qualify and validate biopharmaceutical and pharmaceutical systems and processes.

The course will include background and instructional information on modern risk and science based qualification and validation methods, group participation, and workshop exercises in protocol development, risk assessment, and results analysis.

Who Should Attend

Managers and technical support staff responsible for the design, planning, qualification, validation, operation, testing and investigation of biopharmaceutical and pharmaceutical processes will benefit from this course.

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Agenda

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

    • Apply risk management in making informed scientific decisions related to qualification and validation
    • Interpret the regulatory basis and expectation for risk based qualification and validation programs
    • Identify critical process steps and qualification/validation approaches
    • Prioritize and plan effective qualification and validation programs
    • Select efficient qualification and validation approaches
    • Choose useful test functions and acceptance criteria
    • Develop qualification and validation plans, procedures, and protocols
    • Assess failures and conduct investigations
    • Create systems for controlling changes to and maintaining qualification and validation programs

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • 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

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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 September 14, 2018
$1,743

After September 14, 2018
$1,937

Nonmember

On or before September 14, 2018
$2,092

After September 14, 2018
$2,324

Government/Health Authority/Academic

Member

$1,162

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by October 1, 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 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
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Registration Customer Care

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