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Designing and Presenting GXP Training Programs to Meet FDA Requirements

Dec 09, 2020
Bethesda, MD

  • Education
  • The Americas
Cancelled

Overview

This interactive and hands-on training course will take trainees step-by-step through the process of designing and presenting an effective GXP training program. Using many individual and small group exercises, the attendees will practice each skill set after it is explained and will leave with a new program well on the way to completion. Topics to be covered include reviewing past GMP training topics, conducting a needs analysis, selecting a topic tied to facility quality objectives and FDA quality requirements, brainstorming creative approaches, developing the presentation, maximizing presentation success, evaluating training effectiveness, and audit-proofing training documentation.

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Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Elaine Lehekca Pratt
Elaine Lehekca Pratt
Lehecka Pratt Associates, Inc.
Bio
Elaine Lehekca Pratt
Lehecka Pratt Associates, Inc.
Elaine Lehecka Pratt is president of Lehecka Pratt Associates, Inc., a consultancy specializing in pharmaceutical regulatory compliance training. She is also an Industry Professor in Stevens Institute of Technology’s Graduate School of Engineering and Science program in Pharmaceutical Manufacturing where she is the recipient of the 2016 Provost’s Award for Online Teaching Excellence. An experienced public speaker/technical trainer, she holds a B.S. degree from Ursinus College and a M.B.A. degree from Fairleigh Dickinson University. Before starting Lehecka Pratt Associates in 1986, she worked at Schering-Plough Corporation in production line supervision and as training manager, and served as one of the first presidents of the GMP Training and Education Association, as co-chair of the ASTD Pharmaceutical/Chemical Industry Group, and on the PMA Training and Education Resource Committee. She has published articles in Pharmaceutical Technology, Pharm Tech Japan, Controlled Environments, Journal of Pharmaceutical Innovation, Performance in Practice, and Drug Development and Industrial Pharmacy. She is also a chapter author of Virtual Teams: Mastering the Art and Practice of Online Learning and Corporate Collaboration (Wiley, 2010). Always a popular presenter, she has spoken at national/international meetings of ASQ, ASTD, PDA, PMA, GMP TEA, APhS, SME, ISPI, Pharm Tech and Interphex, and served on the planning committees for the PDA and GMP TEA Biennial Training Conferences.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Implement a GXP training needs analysis
    2. Relate potential course topics to facility quality objectives and FDA quality requirements
    3. Examine creative approaches to GXP training
    4. Explain the process for training program development
    5. Select appropriate methods of evaluation of training effectiveness
    6. Identify ways to audit-proof training documentation
  • Who Should Attend

    This training course is intended for professionals who are involved GXP training for drug manufacturing.

    Departments
    Quality Assurance, Manufacturing

    Roles
    Trainer, Training Specialist, Specialist, Technician

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Travel

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

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Registration Fees

Early Registration
Registration Type Price By October 23, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979

Regular Registration
Registration Type Price After October 23, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979

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