Live Webinar

GMP Change Controls: Assessing Validation Impact and Regulatory Risk Before Implementation

Course Information

Course Type: Live Webinar
Course ID: LSP2997
Date: November 16, 2026
US Eastern Time: 11:00 AM EST
GMT: 4:00 PM GMT
Duration: 60 Minutes
Presenter: Danielle DeLucy

Registration Options

Date: November 16, 2026
US Eastern Time: 11:00 AM EST
GMT: 4:00 PM GMT
Duration: 60 Minutes

Individual Access: USD 290.00
Team Access (2–5 Attendees): USD 390.00
Team Access (6–10 Attendees): USD 490.00

About the Course

A practical approach to evaluating proposed GMP changes before implementation, including change classification, product and process risk, validation and testing requirements, regulatory impact, implementation controls, and the evidence needed to justify the change.

Key Areas Covered

Classifying GMP changes by type, significance, scope, and potential process impact
Assessing effects on product quality, process performance, facilities, equipment, specifications, and the validated state
Determining appropriate testing, qualification, validation, or revalidation before implementation
Applying quality risk assessment to change evaluation and implementation planning
Evaluating regulatory impact, documentation requirements, approvals, and implementation controls
Post-implementation monitoring and effectiveness checks for intended and unintended effects

Who Should Attend

Quality Assurance
Quality Systems
Validation
Manufacturing and Production
Engineering
Facilities
Quality Control
Regulatory Affairs
Technical Operations
Process Owners and Change Control Owners
Quality and Manufacturing Management

Presenter

Danielle DeLucy

Danielle DeLucy, is the owner of ASA Training and Consulting, LLC, providing pharmaceutical and biologics companies with quality systems and regulatory compliance support. Her industry experience includes Quality Control microbiology, sterility assurance, product quality, and QA oversight of filling and packaging operations. She has supported regulatory inspections, inspection preparation, and organizations responding to warning letters and consent decrees while strengthening quality systems and compliance practices.