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Process Validation: A Lifecycle Approach — Oral Solid Dosage/ Semisolid Dosage Forms Annex - New Course

Oct 29, 2018
Bethesda, MD

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

Overview

The participant will learn how to employ process understanding and quality risk management principles to the three Process Validation concepts described below:

  • Stage 1: Process Design
  • Stage 2: Process Qualification
  • Stage 3: Continued (Ongoing) Process Verification (CPV)

In addition, the participant will learn how to apply Stage 3 CPV concepts to existing company/site legacy products.

Who Should Attend

Managers, directors and new or experienced professionals in process development, process validation, and quality assurance personnel will benefit in taking this course.

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Agenda

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

    • Describe the requirements for the development of of a new product using a Process Design Stage and apply the lessons learned to your workplace
    • Explain the requirements for the development of a new product using a Process Qualification Stage and apply the lessons learned to your workplace
    • Demonstrate the ability to respond to unexplained departures from established ranges with clear identification of impact including linkage to the firm’s quality systems
    • Develop a Stage 3 Continuous Process Validation program for legacy products which includes linkage to the firm’s quality systems

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

More information coming soon.

By Car

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Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

Standard

Member

On or before September 14, 2018
$1,192

After September 14, 2018
$1,325

Nonmember

On or before September 14, 2018
$1,431

After September 14, 2018
$1,590

Government/Health Authority/Academic

Member

$795

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
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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Contact

Program Inquiries
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Training Course Inquiries

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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