Risk Management and Safety Assurance for Drug-Device Combination Products Training Course
Registration Options
Individual Registration
Group Registration
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:
- Recognize unique challenges and opportunities for effective risk management of drug delivery combination products
- 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
- 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
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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 [email protected].
Featured Trainers
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Kai Kwok
Senior Pharmaceutical Quality Assessor, FDA CDER
Read Bio
Kai Kwok
FDA CDER
Dr. Kwok is a Senior Pharmaceutical Quality Assessor (SPQA) in the Division of Product Quality Assessment I (DPQA I), Office of Product Quality Assessment I (OPQA I), Office of Pharmaceutical Quality (OPQ), CDER at FDA. In this role, he acts as the application technical lead for integrated quality assessment of generic parenteral, ophthalmic, topical, nasal, and oral solid/solution drug products. For the past 10 years, he has been reviewing ANDA, Bio-IND, and Pre-ANDA meeting packages involving complex drug products. Also, he served as a FDA liaison in the USP Packaging and Distribution Expert Committee for developing USP packaging chapters and standards and as a member for development of FDA guidance for drug delivery performance of drug-device combination products. Prior to FDA, he spent over 10 years as a formulation scientist for drug product and process development in pharmaceutical companies. He received his BS in Pharmacy from Temple University and PhD in Pharmaceutical Sciences from University of Michigan.
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Fubin Wu
GessNet™
Read Bio
Fubin Wu
GessNet™
Fubin Wu is the Co-Founder and President of GessNet™, providing consulting and software tools for medical device and drug device combination product risk management, safety assurance cases, cybersecurity, and reliability.
Having served for over 30 companies, Fubin has experience with a broad range of medical products including drug delivery combination products, infusion pumps, insulin pumps, on-body injectors, emergency use injectors, mobile medical applications, digital solutions, implantable devices, cardiovascular devices, robotic surgery devices, IVDs, remote monitoring systems, and blood management systems. He is a member of multiple AAMI working groups including infusion devices, combination products, cybersecurity, and software. He also teaches public courses on medical device and combination product risk management, safety assurance cases, cybersecurity, and software reliability.
Prior to GessNet™, Fubin worked for Medtronic, Hospira, and Haemonetics in the roles of engineer, manager, and director, and spent over 16 years on hardware/software quality and reliability engineering, risk management, and quality management systems.
Fubin has an MS degree in Electrical and Computer Engineering from Oregon Health & Science University (OHSU) and was a software developer at Intel before joining the medical device industry.
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Phoenix Convention Center - South Building
33 S 3rd StreetPhoenix, AZ 85004, USA
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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.