PDA 547 Technical Report No. 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems

Bethesda, MD
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This training course will provide guidance and practical knowledge on how to manage quality risks throughout the manufacturing system lifecycle, as described in PDA Technical Report No. 54-5: Quality Risk Management for the Design, Qualification and Operation of Manufacturing Systems. Through a combination of lecture, workshops, and case studies, attendees will learn and apply a variety of tools and techniques to ensure appropriate management of quality risks for facilities, utilities, equipment, and other manufacturing systems.

Participants will also receive a free copy of PDA Technical Report No. 54-5: Quality Risk Management for the Design, Qualification and Operation of Manufacturing Systems.

PREREQUISITES

Participants enrolling in this training course must have completed the following PDA training courses:

  • PDA 529/529.1 Technical Report No. 54: Foundations of Quality Risk Management or any offerings of the prior PDA training course, Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
  • PDA 531/531.1 Technical Report No. 54-2 and 54-4: Practical Application of Quality Risk Assessment Tools

Additionally, participants should have read PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.

For more options and/or related training courses, please visit the page(s) below.

PDA Quality Risk Management Training Courses

  1. Explain how Quality Risk Management is applied in the lifecycle of manufacturing systems
  2. Apply Quality Risk Management principles and tools during the Design phase of a Manufacturing System
  3. Apply Quality Risk Management principles and tools during the Qualification phase of a Manufacturing System
  4. Apply Quality Risk Management principles and tools during the Operation, Maintenance and Retirement phases of a Manufacturing System lifecycle
Event Location
PDA Training and Research Institute
4350 East West Highway, Suite 110, Bethesda, MD Get Directions

Contact

Program Inquiries
Tel: +1 (301) 656-5900
Exhibition/Sponsorship Inquiries
David Hall
Tel: +1 (240) 688-4405
Training Course Inquiries
Tel: +1 (301) 656-5900
Registration Customer Care
Tel: +1 (301) 656-5900

Standard Pricing

Standard Member Price

$999

GovernmentMember Only

$699

Health AuthorityMember Only

$699

AcademicMember Only

$699

Non-Member

$1,199

See Qualifying Criteria for Member Types.

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].

Download Full Agenda

Day 1

Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

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, Suite 110
Bethesda, MD , USA

The following hotels are located near the training course location:

Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814

Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814

Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814


Please visit the hotel’s website for more information.

How to Get Here
By Air The following airports are near the training course location: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).
By Car There is a parking garage located at the training course location. The fee is $12/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.