Introduction to Validation

Training

In Reading

£ 695 + VAT

Description

  • Type

    Training

  • Level

    Beginner

  • Location

    Reading

  • Duration

    1 Day

  • Start date

    Different dates available

The course provides an overview of the concept of validation as described in Annex 15 to Eudralex Volume 4. It covers responsibilities and terminology (validation, verification, qualification), and looks at the requirements of equipment qualification (IQ, OQ and PQ), process and cleaning validation, analytical method validation. The course also examines the documentation and project management aspects of validation studies. The need for effective change management and life-cycle management will be discussed.

Facilities

Location

Start date

Reading (Berkshire)
See map
Earley Gate, Whiteknights Road, RG6 6BU

Start date

Different dates availableEnrolment now open
Different dates availableEnrolment now open
Different dates availableEnrolment now open

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Reviews

Subjects

  • Validation
  • Qualification
  • Verification
  • Pharmaceutical manufacturing
  • Equipment qualification
  • Cleaning validation
  • Analytical method validation
  • Documentation
  • Regulatory Compliance
  • Good Manufacturing Practice (GMP)

Teachers and trainers (1)

Steve Porter

Steve Porter

None

Course programme

Course Overview

The course provides an overview of the concept of validation as described in Annex 15 to Eudralex Volume 4. It covers responsibilities and terminology (validation, verification, qualification), and looks at the requirements of equipment qualification (IQ, OQ and PQ), process and cleaning validation, analytical method validation. The course also examines the documentation and project management aspects of validation studies. The need for effective change management and life-cycle management will be discussed.

Suitability

The course will be of value to all pharmaceutical professionals, including management, laboratory and manufacturing staff, and engineering personnel, who need to understand the current GMP expectations of validation in today’s regulatory environment.

Learning Outcomes

At the end of the course you will:

  • Understand the regulatory expectations
  • Know how to evaluate validation and qualification requirements
  • Be able to plan and document validation studies
  • Understand the link to change management and ongoing lifecycle management

Additional information

https://www.rssl.com/home/pharmaceutical-training/pharmaceutical-training-courses/introduction-to-validation

Introduction to Validation

£ 695 + VAT