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

Oct 20, 2022
Palm Springs, CA

  • Education
  • The Americas
Closed

Overview

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.

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

PDA Parenteral Packaging Training Courses
PDA Universe of Pre-Filled Syringes and Injection Devices Training Courses

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

Fubin Wu
Fubin Wu
GessNet™
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.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Recognize challenges and opportunities for effective risk management of drug delivery combination products
    2. Apply knowledge on how to use risk analysis tools such as: Hazard Analysis, Fault Tree and Reliability Analysis, FMEAs, and 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
  • Who Should Attend

    This training course is intended for professionals who are involved in risk management and safety assurance cases related to drug delivery devices and combination products.

    Departments
    Quality Control, Engineering, Manufacturing, Quality Assurance Operations, Research and Development, Regulatory Affairs, Validation

    Roles
    Analyst, Specialist, Supervisor, Manager, Auditor/Inspector

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Travel

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.

Palm Springs Convention Center

277 N. Avenida Caballeros
Palm Springs, CA

  • Accommodations

    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

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. This airport is serviced by numerous carriers. Taxi fares from PSP are approximately $10 one way, not including tip, and will take about 7 minutes.

By Car

The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. Parking is located to the east of the facility (Caballeros Lot) and southwest of the facility (Andreas Lot).

Other Options

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Directions

Registration Fees

Early Registration
Registration Type Price By September 5, 2022
Member $899
Non-member $1,079
Gov't/Health Auth./Academic* $699
Regular Registration
Registration Type Price After September 5, 2022
Member $999
Non-member $1,199
Gov't/Health Auth./Academic* $699

* For this member type or discount, online registration is not available, please contact [email protected].

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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