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Assay Validation by Design - New Course

Dec 07, 2018
Bethesda, MD

Completion of this course will enable participants to plan, design and analyze data collection protocols to develop, and improve chemical assays while also collecting the data needed to validate to the USP and ICH requirements.

  • Education
Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

Overview

Pharmaceutical assay validation is both a good business practice and a requirement of the current Good Manufacturing Practice Regulations. This introductory course presents assay validation as specified in the ICH guidelines, USP, FDA documents and the literature.

Completion of this course will enable participants to plan, design and analyze data collection protocols to develop and improve chemical assays while also collecting the data needed to validate to the USP and ICH requirements. Additionally, participants will be able to design, execute, and report a statistically consistent validation of an analytical method including considerations such as accuracy, precision, specificity, limit of detection/limit of quantitation/linearity and range, and robustness and ruggedness.

Who Should Attend

This introductory seminar is for those working in chemical assay validation. It is intended for analytical laboratory chemists, supervisors and managers. Validation engineers, quality control/assurance personnel and others with an interest or responsibility for validation will likewise benefit.

Prerequisites

It is recommended that the participant read ICH Q2 (R1).

Agenda

  • Upon completion of this course, you will be able to:

    • Design an assay validation that uses Plackett-Burman DoE’s to demonstrate ruggedness with fewer experiments than the typical assay validation runs
    • Identify the sources of variation in a method
    • Quantify the best case and a worst level of variation

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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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

Standard

Member

On or before October 23, 2018
$1,192

After October 23, 2018
$1,325

Nonmember

On or before October 23, 2018
$1,431

After October 23, 2018
$1,590


Government/Health Authority/Academic

Member

$795

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by November 7, 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 info@pda.org or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

PDA Training and Research Institute
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

* 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 registration@pda.org 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 registration@pda.org. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
TRI@pda.org

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

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Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

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