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PDA 143.1 Designing and Presenting GXP Training Programs to Meet FDA Requirements

Jan 11 - Jan 12, 2021
9:00 AM
-
12:00 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

This interactive online 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.

Agenda

  • Day 1
  • Day 2
  • GXP Training Programs - What do we need to do? (90 min)

    • Requirements
    • Needs Analysis
    • Risk-Based Prioritization of Topics

    Break (15 min)


    GXP Training Programs - Where do we start? (75 min)

    • Creative Training Approaches
    • Ensuring Management Support
  • GXP Training Programs - How do we get there? (90 min)

    • Program Development Techniques
    • Factors for Success

    Break (15 min)


    GXP Training Programs - Did it work? (75 min)

    • Testing and Evaluation of Effectiveness
    • Audit-Proofing Training Documentation

Trainers

Elaine Lehekca Pratt
Elaine Lehekca Pratt
Lehecka Pratt Associates, Inc.

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

Who Should Attend

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

Departments
  • Quality Assurance Operations
  • Training

Roles
  • Specialist
  • Supervisor
  • Manager
  • Training Developer

Registration Fees

Register Now
Registration Type Price
Member $599
Non-member $599
Gov't/Health Auth./Academic $599

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