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Injectable Combination Product Integrated Development

Oct 07, 2020
Las Vegas, NV

  • Education
  • The Americas

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Overview

The regulation of combination products continues to evolve in the US and Europe with new practices that have greater scrutiny for safety and performance. The effectiveness and compatibility of the delivery device with the drug product is critical to patient safety. However, it is difficult to define the device inputs in early development when the drug formulation and dosing is not yet final. Pharmaceutical companies, device engineers, and suppliers have a common goal to identify risks to combination product quality with early planning to enable parallel development.

The aim of this training course is to bring together multiple viewpoints with a line of sight to finished combination product from early development through commercialization. A background on the requirements from different regulatory branches will be given, with a focus on Design Controls and Quality by Design alignment. Interactive discussion across various disciplines will bring to light the importance of early planning to address potential failures. There will be examples of making informed decisions about suitable performance and safety data at the right time in order to guide application information. This training course will provide practical experience on understanding the role of human factors, recognizing essential performance requirements, and qualifying primary container systems.

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

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

Trainers

Fran DeGrazio
Fran DeGrazio
West Pharmaceutical Services, Inc.
Diane M. Paskiet
Diane M. Paskiet
West Pharmaceutical Services, Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Explain the concept for integrated injectable drug-delivery system/device
    2. Merge aspects of Design Controls (DC) with Quality by Design (QbD)
    3. Identify considerations for contact material compatibility and safety
    4. Build line of sight data packages for delivery systems performance starting at development through regulatory approval
    5. Recognize goals for a total product life cycle (TPLC) model with feedback loops from inception
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in finished combination product from early development through commercialization.

    Departments
    Engineering, Facilities, Manufacturing, Packaging, Pharmacy, Quality Assurance, Quality Control, Quality Systems, Quality Compliance, Regulatory Affairs, Research and Development

    Roles
    Auditor, Consultant, Director, Manager, Pharmacist, Scientist, Specialist, Supervisor

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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

Make a Reservation
  • 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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Training Course Inquiries

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

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

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Tel: +1 (301) 656-5900 ext. 115
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