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2018 PDA Extractables and Leachables Training Course

Nov 08 - Nov 09, 2018
Taipei, Taiwan

This Training Course will cover all aspects of extractables and leachables and will include case studies.

  • Education
  • Asia-Pacific

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Overview

The 2018 PDA Extractables and Leachables Training Course will cover all aspects of extractables and leachables, including:
  • Understanding the Polymers Used in the Manufacture of Pharmaceutical Containers and Closures
  • Understanding Glass as an Important Material Used in the Manufacture of Primary Packaging of Small Volume Parenterals
  • The Mechanism of Leaching
  • Helicopter View on the recent and Upcoming Changes to the US Pharmacopoeia (USP) 
  • How to Perform a Safety Evaluation: Risk Assessment on Extractables and Leachables
  • How to Set-up Extractable and Leachable Studies
  • Analytical Techniques to Perform Extractables and Leachables Research
  • E/L Testing for a Small Volume Parenterals (Liquid and LYO applications)
  • E/L testing for Disposable and Single-Use Systems in Bioproduction

Agenda

  • Thursday, 8-November

    8:00 – 17:00
    Registration Open

    9:00 – 12:00

    Introduction on Extractables and Leachables

    • What is the importance of a good E/L-qualification
    • Historical cases of leachables, impacting the quality or the safety of a drug product
    • Global regulatory requirements (FDA, EMA, etc.) for primary packaging

    Understanding the Polymers Used in the Manufacture of Pharmaceutical Containers and Closures

    • Types of polymers: examples in medical/pharmaceutical use
    • Understanding the composition of polymers
    • Making the distinction between compounds that are intentionally added to a material/polymer and not intentionally added substances

    Understanding Glass as an Important Material Used in the Manufacture of Primary Packaging of Small Volume Parenterals

    • Types of glass and their composition
    • Additives added to glass, role and function
    • Glass: the manufacturing process
    • The issues with glass in parenteral applications
    • Glass delamination and other quality issues with glass

    12:00 – 13:00
    Networking Luncheon

    13:00 – 17:00

    The Mechanism of Leaching

    • What are the physicochemical parameters to be considered when trying to understand polymer migration
    • How do leachables move through a polymer, the diffusion model
    • Special cases in migration

    Helicopter View on the recent and Upcoming Changes to the US Pharmacopoeia (USP)

    • USP <661> Plastic Packaging Systems and their Materials of Construction
    • USP <661.1> Materials of Construction
    • USP <661.2> Plastic Packaging Systems for Pharmaceutical Use
    • USP <665> Polymeric Materials in Manufacturing of (Bio)Pharmaceutical Drug Products
    • USP <1661> Evaluation of Plastic Packaging
    • USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
    • USP <1664> Assessment of Leachables Associated with Pharmaceutical Packaging/Delivery Systems

    How to Perform a Safety Evaluation: Risk Assessment on Extractables and Leachables

    • Toxicology 101
    • EMA guideline on genotoxic impurities
    • ICH M7 (DNA reactive Impurities) and it’s suggested staged approach.
    • The Threshold concept of PQRI (OINDP and PDP/ODP)
    • Examples

    Friday, 9-November

    8:00 – 17:00
    Registration Open

    9:00 – 12:00

    How to Set-up Extractable and Leachable Studies

    • Designing extraction studies that are compliant with USP <1663>
    • Selecting the right conditions for extraction
    • How to select the right compounds to monitor in a leachable study?
    • Designing a leachable study compliant with USP <1664>

    Analytical Techniques to Perform Extractables and Leachables Research

    • The importance of sample preparation: the corner stone in E/L research.
    • What are the target compounds for material research?
    • How does a classification of these compounds assist in finding the right analytical technique?
    • From basic “screening” methodologies to state-of-the-art equipment:

    E/L Testing for a Small Volume Parenterals (Liquid and LYO applications)

    • Glass syringes: the issues with tungsten, glue residues and silicone oil and glass metals leaching
    • The issue with rubbers: the plunger, the needle shield, or the tip cap: different approaches needed?
    • The impact of secondary packaging: option or necessity?
    • Setting up extractable and leachable studies for a pre-filled syringe
    • Primary packaging for the lyophilized drug product – modus of interaction with the DP

    12:00 – 13:00
    Networking Luncheon

    13:00 – 17:00

    E/L testing for Disposable and Single-Use Systems in Bioproduction

    • How to classify the risk of different single use systems in the bioproduction process?
    • Understanding BPSA and BPOG recommendations, and how they can be implemented in the study design
    • Performing e/l studies on filters: potential approaches

    Case Study Section

    • Case study examples for primary packaging: pre-filed syringes, lyophilized drug product containers, blow-fill-seal applications, large volume parenterals, etc.
    • Case study examples of the impact on secondary packaging: labels, printing inks, carton boxes, etc.
    • Case study examples of single-use systems: bags, filters, tubing

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • 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:
    Type of Activity: Not Applicable

    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 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 PDH credits.

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Travel

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Regent Taipei


Taipei, Taiwan

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

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Directions

Registration Fees

Regular Price

Standard

Member

$675

Nonmember

$855


Government/Health Authority/Academic

Member

$495

Nonmember*

$495


Student Member

Member

$380

Nonmember*

$425


Young Professional Member

Member

$450

All prices in US dollars.

*For this member type or discounted rate, online registration is not available and must be faxed in.

You must be a member to take advantage of this rate.

REFUND FOR COURSES: If your written request is received by October 19, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900.

Contact

Molly O'Neill Moir, CMP
Vice President, Programs & Meetings
Tel: (301) 656-5900 ext. 132
Email: [email protected]

* 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 30 days before the event, no fee will be charged. After this period, 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 30 days before the event, a full refund will be given minus a $200 fee. After this period, 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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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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