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Parenteral Drug Association Connecting People, Science and Regulation ®

Drug Device and Combination Product Risk Management and Safety Assurance Cases

Mar 15 - Mar 15, 2019 |
Mar 15, 2019 |
Marriott Marquis San Diego | San Diego, CA
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

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. This challenge also impacts regulatory bodies such as FDA in the evaluation of risks associated to the combination products, particularly when manufacturer specific practices in risk management vary across the industry. 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 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.

Who Should Attend

This training course is designed for pharmaceutical manufacturing staff in the following areas:
  • Auditors/Inspectors/Investigators/Reviewers
  • Directors/Managers/Supervisors
  • Engineers
  • Executives
  • Operators/Technicians
  • Researchers
  • Scientists

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

  • Explain Risk Management Fundamentals
  • Recognize challenges and opportunities for effective risk management of drug delivery combination products
  • Apply knowledge on how to use risk analysis tools such as: Hazard Analysis, Fault Tree and Reliability Analysis, FMEAs, and 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

Standard

Member

On or Before January 29, 2019
$899

After January 29, 2019
$999

Nonmember

On or Before January 29, 2019
$1,079

After January 29, 2019
$1,199


Government/Health Authority/Academic*

$599

*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 Accommodations and 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 registration@pda.org or +1 (301) 656-5900. SUBSTITUTION: If a substitution request is sent by February 13, 2019, no fee will be charged. After February 13, 2019, 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 by February 13, 2019, a full refund will be given minus a $200 fee. After February 13, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

General Course Information

Please arrive at the 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.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

Marriott Marquis San Diego
333 West Harbor Drive
San Diego, CA USA 92101

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

Fubin Wu, Co-founder, GessNet™ Risk Management and Assurance Case Consulting

Fubin Wu is the co-founder and president of GessNet™, consulting in risk management, safety assurance case and cybersecurity. He has extensive experience in drug delivery combination products, infusion pumps, mobile medical applications, implantable devices, remote monitoring systems, and standalone software devices. Prior to GessNet™, Fubin spent over 16 years on medical device quality and regulatory affairs, hardware/software reliability engineering and risk management, and served roles of engineer, manager, and director. Fubin has an MS degree in Electrical and Computer Engineering from Oregon Health & Science University (OHSU), and was a software developer at Intel prior to his career in the medical device industry.

Alan Stevens, Branch Chief, General Hospital Devices Branch, ODE/CDRH, U.S. Food and Drug Administration

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #569 | ACPE #0116-0000-18-027-L04-P | 0.6 CEUs
Type of Activity: Knowledge

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 6 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 6 PDHs.

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https://store.pda.org/Meetings/Login.aspx?ID=4770

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