Practical Application of Quality Risk Assessment Tools Training Course (PDA 531)
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Registration Options
Individual Registration
Group Registration
OVERVIEW
This training course will cover the selection and application of various quality risk assessment tools. Different case studies from drug substance manufacturing, packaging, and labeling will be used to demonstrate appropriate selection and effective application of the various tools.
Attendees will also get hands-on practice with the more detailed and structured risk assessment tools - PHA, FMEA and FTA. In each of the application case studies, all stages of the QRM process will be covered including identification of risks, risk controls, estimating residual risks, practicing documentation and communication of outcome to management, and obtaining approval from decision makers.
Participants will also receive a free copy of:
- PDA Technical Report No. 54-2: Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling
- PDA Technical Report No. 54-4: Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances
PREREQUISITES
This training course is part of PDA's QRM Application Track. Participants enrolling in this training course must have completed one of the following PDA training courses:
- Fundamentals of Quality Risk Management Training Course (PDA 529)
- Any offerings of the prior PDA training courses, PDA 529/529.1 Technical Report No. 54: Foundations of Quality Risk Management or Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
LEARNING OBJECTIVES
Upon completion of this event, the attendee will be able to:
- Apply the formality spectrum concept for risk assessment tools
- Explain why and how tool selection is important in ensuring the right outcomes and decisions from a QRM application
- Examine considerations when selecting the appropriate risk assessment tool
- Demonstrate where and how application of simple risk assessment tools such as checklists, simple decision trees, technical assessments etc. can be used as alternatives to more detailed risk assessment tools such as PHA, FMEA, FTA
- Use structured risk assessment tools such as PHA, FMEA and FTA
WHO SHOULD ATTEND
This event is intended for professionals who apply quality risk management tools related to chemistry, manufacturing and controls, process development and process engineering and management.
RELATED EVENTS
Highlighted Trainers
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Location and Travel
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.
National Center for Therapeutics Manufacturing (NCTM)
100 Discovery Drive, 4482 TAMUCollege Station, TX 77843 USA
Accommodations
Hilton College Station and Conference Center
801 University Dr E College Station, TX 77840
https://www.hilton.com/en/hotels/cllchhf-hilton-college-station-and-conference-center/
Holiday Inn & Suites College Station-Aggieland
2500 Earl Rudder Freeway & Hwy 6 College Station, TX 77840
https://www.ihg.com/holidayinn/hotels/us/en/college-station/cllsp/hoteldetail/rooms
Residence Inn by Marriott Bryan College Station
720 University Drive East College Station, TX 77840
https://www.marriott.com/en-us/hotels/cllri-residence-inn-bryan-college-station/overview/l
Courtyard by Marriott Bryan College Station
3939 State Highway 6 South College Station, TX 77845
https://www.marriott.com/en-us/hotels/cllcy-courtyard-bryan-college-station/overview
Registration
Pricing Options
Early Registration
Register by 15 March 2026
Member Price
$2,249Non-Member
$2,699
Standard Registration
Register after 15 March 2026
Member Price
$2,499GovernmentMember Only
$1,749
Health AuthorityMember Only
$1,749
AcademicMember Only
$1,749
Non-Member
$2,999
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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We're currently finalizing our list of sponsors and will share the details shortly.
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