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Extractables and Leachables for Parenteral Applications - Japan

Oct 31 - Nov 01, 2019
Tokyo, Japan

  • Education
  • Asia-Pacific

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Overview

When making parenteral drug products, pharmaceutical companies are faced with the regulatory requirements to further investigate the materials that will be in contact with the drug product either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, quality issues – i.e. for biopharmaceuticals – have become an additional concern.

This training course will look at Extractables and Leachables (E/L) from many different angles:

  • Regulatory Requirements and Guidelines eg. USP <1663> (Extractables Testing), USP <1664> (Leachables Testing), USP <661> (Plastic Packaging Systems), USP<665> versus BPOG (for Single Uses Systems)
  • Material & Polymer Science
  • Mechanisms of Leaching and Material-Drug Product Interaction
  • Analytical E/L Methodologies
  • E/L Study Design for Different Packaging Systems
  • Large Volume Parenterals
  • Lyo Applications

Several interesting case studies on the above topics will also be presented.

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

Piet Christiaens
Piet Christiaens
Nelson Labs NV

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify which regulations are to be followed and what is applicable
    2. Recognize the impact of the physicochemical properties of a polymers and their impact on the leachable mechanism
    3. Identify which analytical techniques are necessary in a comprehensive E/L program and what they should accomplish
    4. Assess the results of an E/L program from a safety perspective
    5. Design an E/L study that is compliant with the regulatory requirements, by choosing the right set of testing conditions
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in contamination control strategy development for sterile drug manufacturing.

    Departments
    Engineering, Quality Assurance, Quality Control, Packaging, Regulatory Affairs

    Roles
    Engineer, Specialist, Analyst, Supervisor, Manager

  • Accreditation

    Accreditation

    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 # / ACPE # / CEUs: 577 / N/A / 0
    Type of Activity: Application

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    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 0 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 (PDH) 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 0 PDH credits.

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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.

Sheraton Miyako Hotel

1 Chome-1-50 Shirokanedai
Tokyo, Japan

Make a Reservation
  • Accommodations

    A block of rooms have been reserved for meeting participants. The rate is $30,450 JPY inclusive of taxes and breakfast. Reservations must be secured by Saturday, October 5, 2019. After this date, reservations can be made on a space and rate available basis only.

    To reserve a room at the discounted group rate please use the following link:
    https://advance.reservation.jp/miyakohotels/stay_pc/rsv/cc_pln_dtl_redirect.aspx?cp=2&lang=en-US&hi_id=1&smp_id=935&cp_id=2019APRC&is_cal=True

    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

FROM NARITA AIRPORT

By Limousine Bus
Narita Airport → (Limousine bus: Approx. 120 min) → Hotel
Limousine Bus Fares

Adult (Junior high student or older) 3,100 JPY
Child (Elementary school student or younger) 1,550 JPY

FROM HANEDA AIRPORT

By Limousine Bus
Haneda Airport → (Limousine bus: Approx. 75 min) → Hotel

Adult (Junior high student or older) 820 JPY
Child (Elementary school student or younger) 410 JPY

By Car

BY TOKYO CITY BUS

Journey time: Approx. 5 min

  • For the journey from Meguro Station to the hotel by the Tokyo City Bus, take a bus bound for Ooi-keibajo (Ooi Racetrack) <Line Shina 93> and get off at the Shirokanedai Station bus stop.
  • For the journey from Shinagawa Station to the hotel by the Tokyo City Bus, take a bus bound for Meguro Station <Line Shina 93> and get off at the Shirokanedai Station bus stop.

Other Options

BY TRAIN

Train
Shinagawa Station → (JR Yamanote Line 160 JPY/8 min) → Meguro Station → (Subway 170 JPY/2 min) → Shirokanedai Station → (Approx. 4 min walk) → Hotel

Taxi
From Shinagawa Station Approx. 7 min/Approx. 1,100 JPY
From Meguro Station Approx. 5 min/Approx. 730 JPY

FROM STATION

Hotel Shuttle Bus
The hotel also serves a free shuttle bus on these routes in some time periods of a day. Please see the below
“Hotel Shuttle Bus” description.

Journey time: Meguro Station Approx. 5 min
Journey time: Shinagawa Station Approx. 7 min

  • Meguro Station ←→ Sheraton Miyako Hotel Tokyo
  • Sheraton Miyako Hotel Tokyo → Shinagawa Station

Directions

Registration Fees

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

* 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 Oct 01, 2019, no fee will be charged. After Oct 01, 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 Oct 01, 2019, a full refund will be given minus a $200 fee. After Oct 01, 2019, 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

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Exhibition Inquiries
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
[email protected]

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