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Drug Delivery Device and Combination Product Risk Management and Safety Assurance Cases - Taiwan

Nov 14 - Nov 15, 2019
Taipei City, Taiwan

  • Education
  • Asia-Pacific
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 new 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.

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Agenda

  • Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.

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 drug manufacturing.

    Departments
    Manufacturing, Quality Assurance, Quality Control, Engineering, Research and Development

    Roles
    Auditors, Inspectors, Reviewers, Supervisors, Managers, Specialists

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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.

Grand Victoria Hotel

No. 168, Jingye 4th Road, Zhongshan District
Taipei City, Taiwan

  • Accommodations

    A block of rooms have been reserved for meeting participants. The rate is NT $4,500 inclusive of taxes and breakfast. Reservations must be secured by Friday, October 11, 2019. After this date, reservation can be made on a space and rate available basis only.

    To reserve a room at the group rate please email [email protected] and include that you are booking to attend PDA Taiwan 2019.

    Individual Cancellation

    Please be aware that obtaining and cancelling hotel reservations is the responsibility of the 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.

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

The Taipei Songshan Airport (TSA) is 14 minutes (6.2km) from the hotel.

By Car

Traveling North on the Zhongshan North-South Freeway

Move into the right lane after the Linkou Interchange and get onto the high elevated section of the freeway at the 18KM marker. Exit the freeway at the Tiding Boulevard Interchange and turn left onto Tiding Boulevard. Turn left at Lequn 2nd Road then right onto Zhifu Road to reach the hotel.

Traveling north on Freeway No. 2

After passing the off ramp for Freeway No. 5, get into the right lane and exit at the Nangang Interchange. Take the off ramp down to Huandong Boulevard and proceed to Lequn 2nd Road. Turn left, then right at Zhifu Road to reach the hotel

*The hotel has ample underground parking.

Other Options

By Bus

Dozens of bus lines pass the Grand Victoria Hotel including lines 21, 222, 247, 267, 286, 287, 620, 646, 72, 902, Red 2, Brown 16, Blue 26, Blue 7 and others. Get off at the Miramar stop and we are only a 3-minute walk away.

By MRT

On the MRT, take the Wenhu Line to Jiannan Road and exit the Number 3 Exit then walk to the hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
Member USD $899
Non-member USD $899
Gov't/Health Auth./Academic* USD $899



* 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.

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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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