PDA 569 Drug Delivery Device and Combination Product Risk Management and Safety Assurance Cases
Registration Options
Individual Registration
Group Registration
Effective risk management is a new challenge for many drug/biologic companies as they become drug/biologic and combination product manufacturers from traditional drug/biologic manufacturers. In addition, constructing safety assurance cases helps to ensure the completeness and correctness of risk management results and the adequacy of the risk management process. When being proactively developed, safety assurance cases become an effective method to improve risk management effectiveness.
This training course will help you explain in depth effective risk management principles, drug delivery combination product best practices and tools, including Hazard Analysis, Fault Tree and Reliability Analysis, Design/Process FMEAs, Use Error Risk Analysis, and Safety Assurance Cases, from effectiveness and regulatory compliance perspective.
PDA Parenteral Packaging Training Courses
PDA Universe of Pre-Filled Syringes and Injection Devices Training Courses
- Recognize challenges and opportunities for effective risk management of drug delivery combination products
- Apply knowledge on how to use risk analysis tools such as: Hazard Analysis, Fault Tree and Reliability Analysis, FMEAs, and Error Risk Analysis
- Identify risk controls effectively and efficiently for drug delivery of combination products
- Indicate the appropriate elements of safety assurance cases that may be useful to demonstrate safety and facilitate communications with regulatory reviewers during premarket reviews
- Identify industry best practices in managing risk and assuring safety through product life cycle
Event Location
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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].
Day 1
Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.
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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.
Palm Springs Convention Center
277 N. Avenida CaballerosPalm Springs, CA , USA
The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA.
Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!
A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel and the Hilton Palm Springs Hotel. The group rate at both hotels is $199 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, 23 September 2022. After this date, reservations can be made on a space-and-rate available basis only.
To make reservations, individuals may click on the reservation link below or call the Renaissance Palm Springs Hotel at +1 (888) 236-2427 or the Hilton Palm Springs at +1 (800) 445-8667. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.
Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.
Renaissance Palm Springs Hotel
888 Tahquitz Canyon Way
Palm Springs, CA
Phone: +1 (760) 322-6000
Website | Reservations Link
Hilton Palm Springs Hotel
400 East Tahquitz Canyon Way
Palm Springs, CA
Phone: +1 (760) 320-6868
Website | Reservations Link
Please visit the hotel’s website for more information.