Skip To The Main Content

Safety Assurance Cases for Combination Products

Sep 27 - Sep 28, 2017
Bethesda, MD

This 2-day course provides attendees with an understanding of safety assurance cases and how they can be applied for combination products to demonstrate safety and facilitate premarket review communications with the FDA.

  • Education
Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

Overview

This 2-day course provides attendees with an understanding of safety assurance cases and how they can be applied to combination products to demonstrate safety and facilitate pre-market review communications with the FDA. It covers the elements of assurance cases; the common issues and resolutions related to assurance cases; and the structure templates and approach for using assurance cases to achieve three important goals: to demonstrate safety, to create and review a safety assurance case with good arguments and evidence, and to relate the results to managing risk and improving product safety.

There will be examples and interactive exercises to reinforce learning and allow participants to apply their new knowledge to create and review safety assurance cases and hear feedback from the FDA reviewers. The program also offers the opportunity for the participants to interact with FDA reviewers on questions related to safety assurance cases.

Agenda

  • A. Course Introduction
  • B. Risk Management and Safety
  • C. Assurance Case Method
  • D. Safety Assurance Case Argument Structure
  • E. Develop Argument on Risk Mitigation Adequacy
  • F. Develop Safety Argument on Verification & Validation Adequacy
  • G. Develop Safety Argument on Reliability Adequacy
  • H. Develop Confidence Argument on Safety Case Effectiveness
  • I. Combination Product Industry Practices of Assurance Cases – Case Study
  • J. Assurance Cases, Risk Management, Safety and Regulatory Science

Who Should Attend

  • Regulatory Affair Professionals
  • Safety/Risk Management Engineers
  • System and R&D Engineers
  • Quality Assurance
  • Management (Managers, Directors, or Senior Management)
  • Industry Consultants
  • 3rd Party Reviewers
  • Patient Safety Advocators
  • Any professionals who are interested to learn about safety assurance case method and its applications to combination products or medical devices.

Prerequisites

No previous experience with safety assurance cases is required. A basic understanding of medical device risk management concepts and terminology would be a plus.

Agenda

  • Upon completion of this course, you will be able to:

    • Explain assurance case concepts, principles and terminology
    • Recognize different formats for safety assurance cases and the pros and cons associated
    • Recognize what elements of safety assurance cases that maybe useful to demonstrate safety and facilitate communications with the FDA reviewers during premarket reviews
    • Get answers from FDA on questions related to safety assurance cases for combination products
    • Recognize safety assurance case structure templates for combination products
    • Generate safety assurance case leveraging risk management information
    • Write safety assurance case arguments in detail with appropriate rigor
    • Choose proper safety assurance case evidence
    • Recognize possible limits that may be associated with standard risk management techniques
    • Identify when and how safety assurance case methods enhance risk management
    • Recognize common issues related to assurance cases and resolutions
    • Identify fallacies in safety assurance case arguments

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

Got a Question? We have answers

Contact Us

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.

PDA Training & Research Institute

4350 East-West Highway
Bethesda, MD

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

Standard

Member

On or before August 14, 2017
$1,709

After August 14, 2017
$1,899

Nonmember

On or before August 14, 2017
$2,051

After August 14, 2017
$2,279


Government/Health Authority/Academic

Member

$1,139

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by August 28, 2017, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900.

Class Schedule

All courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 - 1:00 p.m. Snacks will be provided during the morning break from 10:00 - 10:15 a.m. and the afternoon break from 2:30 - 2:45 p.m.

Location

This course will take place at:

PDA Training & Research Institute
4350 East West Highway
Suite 150
Bethesda, MD 20814 USA
Phone: +1 (301) 656-5900

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: [email protected]

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially