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

Oct 07, 2020
Las Vegas, NV

  • Education
  • The Americas

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

Agenda

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

Trainers

Chris Bielefeld
Chris Bielefeld
Eli Lilly and Company
Fubin Wu
Fubin Wu
GessNet

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

    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.

Rio All-Suites Hotel and Casino

3700 W Flamingo Road
Las Vegas, NV

  • Accommodations

    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 Rio Hotel and Casino. The rate is $149 for single or double occupancy. Guestroom rates are subject to discounted resort fee ($20 per night) and State and Local taxes.

    Reservations must be secured by Friday September 4, 2020. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 11:00 a.m.

    To make reservations, individuals may click on the reservation link above or call the Rio Hotel and Casino at +1 (888) 746-6955. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    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 date, unless otherwise specified on your reservation information.

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

McCarran International Airport (LAS) is approximately 4 miles from the Rio Hotel and Casino and all major carriers service this airport.

Taxi fares from LAS are approximately $27 one way, not including tip, and will take about 10 minutes.

By Car

Free valet or self-parking is available for both registered and non-registered guests.

Other Options

Ride Share Pick up from Terminal 1

The Ride Share pick up is located on level 2 of the parking garage.

  • From Baggage Claim, take the elevator near door #2 up to level 2.
  • Cross the pedestrian bridge on level 2 to the Terminal 1 Parking Garage.

Ride Share Pick up from Terminal 3

The Ride Share pick up is located on the Valet level of the Terminal 3 parking garage.

  • From Baggage Claim, take the elevator near door #52, #54 or #56 up to level 1.
  • Cross the pedestrian bridge on level 1 to the Terminal 3 Parking Garage

Directions

Registration Fees

Early Registration
Registration Type Price By August 23, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979


Regular Registration
Registration Type Price By August 23, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979


* 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 by Sep 23, 2020, no fee will be charged. After Sep 23, 2020, 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 Sep 23, 2020, a full refund will be given minus a $200 fee. After Sep 23, 2020, 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.

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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]

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