DUBLIN–(BUSINESS WIRE)–The “Change Control Best Practices – Avoiding Unintended Consequences of Changes” conference has been added to ResearchAndMarkets.com’s offering.

This seminar will guide all personnel involved in proposing, assessing, and implementing changes to understand and successfully apply the fundamental change control steps and best practices.

With FDA citing inadequate change control constantly in its 483s and Warning Letters, the prerequisite to ensure that changes are accurately described, justified, assessed for risk, implemented, and documented has come to the fore. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval.

The key focus will remain on:

  • Change proposals
  • Justification / risk assessment
  • Change execution / implementation

The seminar will focus on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc. Document change control will be discussed as a supporting element.

Additionally, this practical, how-to course will illustrate and impart:

  • The importance of subject matter expertise, proper planning, critical thinking skills, and co-ordination of all change activities.
  • Skills needed for applying change controls within an organization.
  • Group exercises to allow participants to practice skill sets with feedback from the instructor.
  • Practical training by having participant teams complete a full write-up for a mock change control.

Learning Objectives:

On completing this course on FDA compliance, participants will be able to:

  • Understand regulatory requirements and FDA expectations for change control
  • Understand the purpose of change control
  • Identify what types of changes are /are not subject to change control
  • Properly describe a change
  • Properly justify a change
  • Develop a comprehensive change execution plan
  • Conduct a proper change risk assessment
  • Accurately execute a change
  • Accurately implement a change
  • Develop a full change control package
  • Utilize critical thinking skills throughout the change control process
  • Avoid pitfalls during the change control process

Who Should Attend:

  • Change proposal authors
  • Reviewers / approvers of change controls
  • Change control system owners
  • Production staff / management
  • Engineering staff / management
  • Validation staff /management
  • QA and QC staff / management
  • Regulatory affairs staff / management


Day 1

08.30 AM – 09.00 AM: Registration

09.00 AM: Session Start

Regulatory Requirements

FDA Change Control Expectations / Warning Letter Examples

Purpose of Change Controls

  • What is Change Control?
  • Why Change Control?
  • A Different Way of Thinking

Change Control Process Model

  • 5 Part Process Model
  • Key Terms and Definitions

Types of Changes Subject to Change Control

  • Products, Materials, Suppliers, Processes, Facilities, Equipment, etc.
  • Like-for-Like Changes

Change Proposal

  • Current State / Proposed State
  • Group Exercise – Change Proposal

Change Justification

  • Science and Compliance Rationale
  • Group Exercise – Change Justification

Change Execution Plan

  • Key Elements
  • Group Exercise – Change Execution Plan

Change Proposal Assessment

  • Risk Assessment
  • Validation, Technical, Regulatory, Quality Assessment
  • Group Exercise – Change Risk Assessment

Day 2

Executing the Change

  • Key Elements

Implementing the Change

  • Key Elements

Change Control Documentation

  • Key Elements

Putting It All Together: A System Viewpoint

Change Control Workshop

  • Participant Teams to Write-Up Mock Change Control, Based on Case Studies Provided by Trainer

For more information about this conference visit https://www.researchandmarkets.com/r/f7yd63



Laura Wood, Senior Press Manager

[email protected]

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