PDA 547 Technical Report No. 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems
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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.
- Explain how Quality Risk Management is applied in the lifecycle of manufacturing systems
- Apply Quality Risk Management principles and tools during the Design phase of a Manufacturing System
- Apply Quality Risk Management principles and tools during the Qualification phase of a Manufacturing System
- Apply Quality Risk Management principles and tools during the Operation, Maintenance and Retirement phases of a Manufacturing System lifecycle
Agenda
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Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.
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Venue Details and Accommodations
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 110Bethesda, 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
Registration
Pricing Options
Standard Registration
Member Price
$999GovernmentMember Only
$699
Health AuthorityMember Only
$699
AcademicMember Only
$699
Non-Member
$1,199
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 registration@pda.org.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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Elevate your brand and maximize your exposure by becoming a sponsor at the PDA 547 Technical Report No. 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.
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Boost your brand and visibility by becoming an exhibitor at the PDA 547 Technical Report No. 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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