PDA Week 2024
PDA 529 Technical Report No. 54: Foundations of Quality Risk Management
Registration Options
Individual Registration
Group Registration
This training course will provide an overview of the QRM process with an emphasis on the principles in ICH Q9 and ICH Q10. A portion of the training course will be focused on how QRM can be integrated into the Pharmaceutical Quality System and the use of QRM principles throughout the product lifecycle.
This training course will further build on the conceptual lessons by teaching practical skills, covering a broad look at QRM tools, templates, facilitation tips, and managing teams and bias. Lastly, this training course will close out with evaluating the power of decision making in using a risk register and a best practice approach for building a QRM program at your company.
Participants will also receive a free copy of PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.
This training course is a prerequisite for all of the QRM Certificate Program tracks. For more information on PDA's QRM Certificate Program, please visit the "PDA Quality Risk Management Training Courses" page below.
Upon completion of this training course, the attendee will be able to:
- Describe the Quality Risk Management (QRM) process and explain the roles and responsibilities
- Describe when, where and how to apply risk management throughout the product lifecycle
- Plan and prepare for quality risk management activities
- Describe the formality associated with QRM tools
- Building a QRM program at your company
For more options and/or related training courses, please visit the following page(s):
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Standard Pricing
Standard 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 [email protected].
Featured Trainers
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Virginia Andreotti-Jones
ValSource
Read Bio
Virginia Andreotti-Jones
ValSource
Virginia Andreotti-Jones is a consultant with ValSource, focused on providing innovative approaches to Quality Risk Management (QRM). Throughout her career, Virginia has played a crucial role in Quality Risk Management, Quality Event Investigations, and Quality Systems. Virginia is highly skilled with a well-rounded expertise in the Quality organization. In addition to QRM, her expertise specifically includes Quality Event Investigations, Quality Systems, Human Error Reduction (Human Performance), QC Equipment Qualification, Change Control, and Project Management. Virginia is also an active volunteer with PDA and currently serves on the Board of the Pacific Northwest Chapter of PDA. She holds a BS in Chemistry from Gonzaga University.
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Tiffany A. Baker, MBA
ValSource Inc.
Read Bio
Tiffany A. Baker, MBA
ValSource Inc.
Tiffany Baker is a quality risk management and microbiology consultant with ValSource, LLC. She specializes in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, facilitating risk assessments, creating a risk-focused culture, and developing risk-based approaches to support contamination control strategies. Tiff is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training Research Institute, and an instructor for the PDA courses on quality risk management foundations as well as practical application of QRM tools. She is also co-lead for the PDA task force on Remote Audits and Inspections. Additionally, she was a member of the core team who co-authored the ISPE Baseline guide 5 - Commissioning and Qualification, incorporating QRM into the process. She has a BS in microbiology from the University of Rhode Island and an MBA from Providence College.
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Request InformationPLEASE 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.
Long Beach Convention and Entertainment Center (LBCEC)
300 E Ocean BlvdLong Beach, CA 90802, USA
Westin Long Beach
333 E Ocean Blvd, Long Beach, CA 90802
+1 (562) 436-3000
Located in the thriving downtown district, steps from the Long Beach Convention & Entertainment Center, the Westin Long Beach is designed to maximize your potential. Whether you are staying for business deals or vacation, take time to explore the area, as the Queen Mary and the Catalina Express are just moments away. Return to the hotel and maintain your health at the WestinWORKOUT® Fitness Studio or take advantage of the sunny weather with a swim in the outdoor pool. The restaurant, Navy Proof Food & Spirits, delights your palate with California Coastal cuisine and craft cocktails. Business travelers appreciate our downtown event venues, including a ballroom that seats more than 1,000 attendees. At the end of the day, settle into hotel rooms and suites featuring spacious work areas, high-speed Wi-Fi, flat-screen TVs and the Westin Heavenly® Beds. Select accommodations offer calming views of the ocean for your stay in Long Beach, CA.
Rate: $249 plus applicable taxes and fees
Reservation Link: https://book.passkey.com/e/50719719
Reservation Phone: Coming Soon!
Cut-Off: Monday,
04 March 2024
Visit Marriott Bonvoy for more details on additional reward levels and program benefits.
Renaissance Long Beach
111 E Ocean Blvd, Long Beach, CA 90802
+1 (562) 437-5900
Soak up California vibes at Renaissance Long Beach hotel – situated in the central downtown area, allowing you to immerse yourself in the neighborhood's artistic scene. From the eclectic design to our smiling team, the hotel near downtown Long Beach perfectly reflects the vibrant culture of our city. Satisfy your cravings at our on-site SIP Bar Lounge, which serves craft cocktails and California cuisine. Revel in the Pacific breezes from SIP's spacious outdoor patio or our rooftop pool with city views. At the end of the day, keep those California dreams going strong as you sink into plush bedding and surf the web with free Wi-Fi for Marriott Bonvoy members.
Rate: $269 plus applicable taxes and fees
Reservation Link: https://book.passkey.com/go/PDAMEETING2024
Reservation Phone: +1
(888) 236-2427
Cut-Off: Monday, 04 March 2024