PDA 569 Drug Delivery Device and Combination Product Risk Management and Safety Assurance Cases

Phoenix, AZ
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This training course offers an in-depth explanation of effective risk management strategies specifically tailored for the unique challenges of drug device combination products. The course will begin by covering key standards and regulations such as ISO 14971, ICH Q9, AAMI TIR 105, and QMSR, diving into best practices for managing risks associated with drug delivery devices and combination products. Participants will engage with practical tools and techniques, including Hazard Analysis, Use Related Risk Analysis, Design/Process FMEAs, Fault Tree and Reliability Analysis, and Risk Matrix. Throughout this training course, participants will also learn how to effectively integrate Risk Management with Design Controls, Quality by Design (QbD) and explore the principles for Essential Performance Requirements (EPRs), Critical Quality Attributes (CQAs), and Control Strategies from engineering science perspective.

The training course will feature a session with an FDA senior pharmaceutical quality assessor, providing insights into quality assessment of injectable drug-device combination products with the focus on ANDA submission. This session will enrich participants’ understanding of the Quality by Design (QbD) approach to risk assessment, product development (suitability for the intended use), and control strategy, preparing them for market readiness.

Additionally, participants will explore the safety assurance case method, which is employed to convincingly argue that a product is safe for its intended use. Discussions will focus on how constructing assurance cases can enhance the completeness, correctness, and adequacy of risk management processes and outcomes. By the end of this training course, participants will be equipped with the knowledge and tools necessary to improve their organization's risk management practices.

Upon completion of this training course, the attendee will be able to:

  1. Recognize unique challenges and opportunities for effective risk management of drug delivery combination products
  2. Apply knowledge on how to use risk analysis tools such as: System Hazard Analysis, Fault Tree and Reliability Analysis, FMEAs, and Use Error Risk Analysis
  3. Identify risk controls effectively and efficiently for drug delivery of combination products
  4. Indicate the appropriate elements of safety assurance cases that may be useful to demonstrate safety and facilitate communications with regulatory reviewers during premarket reviews
  5. Identify industry best practices in managing risk and assuring safety through product life cycle

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

Early Registration

Register by 06 September 2024

Member Price

$899

GovernmentMember Only

$699

Health AuthorityMember Only

$699

AcademicMember Only

$699

Non-Member

$1,079

Standard Registration

Register after 06 September 2024

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].

Agenda is subject to change.

Featured Trainers

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.

Phoenix Convention Center - South Building

33 S 3rd Street
Phoenix, AZ 85004, USA

In Greater Phoenix, innovation is a way of life. Since ancient times, the Sonoran Desert has evoked inspiration, adaptation, collaboration, and innovation. This spirit is an indelible part of the identity and inspires the approach to agriculture, technology, sustainability, hospitality, education, medicine, business and so many other aspects that continue to shape Phoenix's future.

The result? Business is booming in the nation’s fifth-largest city. Technological and software companies are putting down roots at a rapid pace. Leading minds in energy, medicine, transportation, and other industries see Phoenix as a landscape for turning cutting-edge ideas into tools and products that the world benefits from!

Additional Hotel Information

Renaissance Phoenix Downtown (HQ)
  • Rate: $289 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
  • Room Block Opens: Monday, 10 June 2024
Westin Downtown Phoenix
  • Rate: $289 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
  • Room Block Opens: Monday, 10 June 2024
Residence Inn Phoenix Downtown
  • Rate: $279 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
  • Room Block Opens: Monday, 10 June 2024
Courtyard Phoenix Downtown
  • Rate: $269 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
  • Room Block Opens: Monday, 10 June 2024

Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night's room deposit. Individuals will be responsible for payment of their own cancellation fees.

How to Get Here
By Air The closest airport to the Phoenix Convention Center - South Building is the Phoenix Sky Harbor International Airport (PHX - approx. 4 miles/6 km).
By Car The Phoenix Convention Center - South Building is located at 33 S 3rd Street, Phoenix, AZ 85004.