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Extractables and Leachables for Parenteral Applications - Taiwan

Nov 14 - Nov 15, 2019
Taipei City, Taiwan

  • Education
  • Asia-Pacific
Closed

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.

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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
Bio
Piet Christiaens
Nelson Labs NV

Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, TX (US), where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-polymers (Kraton Polymers).

From 2001 onwards, Dr. Christiaens holds the position of Scientific Director at Nelson Labs (formerly Toxikon Europe) where he developed analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries. In addition, he is also leading the R&D department at Nelson Labs, with a focus on understanding the interactions and chemistry of extractables and leachables and developing state-of-the-art analytical methodologies. In the last decade, Dr. Christiaens has been a speaker on the subject of “extractables and leachables” at over 150 Conferences, and since 2014, he has been engaged in the two-day Extractables and Leachables training courses that are hosted by PDA across the Globe. In his current role at Nelson Labs Europe, Dr. Christiaens supports the Strategy and Global Business Development for Extractables and Leachables Service Offerings for Pharmaceutical and Medical Applications.

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

    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

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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.

Grand Victoria Hotel

No. 168, Jingye 4th Road, Zhongshan District
Taipei City, Taiwan

  • Accommodations

    A block of rooms have been reserved for meeting participants. The rate is NT $4,500 inclusive of taxes and breakfast. Reservations must be secured by Friday, October 11, 2019. After this date, reservation can be made on a space and rate available basis only.

    To reserve a room at the group rate please email [email protected] and include that you are booking to attend PDA Taiwan 2019.

    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

The Taipei Songshan Airport (TSA) is 14 minutes (6.2km) from the hotel.

By Car

Traveling North on the Zhongshan North-South Freeway

Move into the right lane after the Linkou Interchange and get onto the high elevated section of the freeway at the 18KM marker. Exit the freeway at the Tiding Boulevard Interchange and turn left onto Tiding Boulevard. Turn left at Lequn 2nd Road then right onto Zhifu Road to reach the hotel.

Traveling north on Freeway No. 2

After passing the off ramp for Freeway No. 5, get into the right lane and exit at the Nangang Interchange. Take the off ramp down to Huandong Boulevard and proceed to Lequn 2nd Road. Turn left, then right at Zhifu Road to reach the hotel

*The hotel has ample underground parking.

Other Options

By Bus

Dozens of bus lines pass the Grand Victoria Hotel including lines 21, 222, 247, 267, 286, 287, 620, 646, 72, 902, Red 2, Brown 16, Blue 26, Blue 7 and others. Get off at the Miramar stop and we are only a 3-minute walk away.

By MRT

On the MRT, take the Wenhu Line to Jiannan Road and exit the Number 3 Exit then walk to the hotel.

Directions

Registration Fees

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


* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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