Duration: 75 Minutes


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This training is intended to help you better understand and get familiar with best practices for Process Validation applicable for the highly regulated biological / pharmaceutical industry. This course is further intended to discuss the life cycle of the Process Validation system. You will learn when a process should be validated, the basic components of a Process Validation (IQ, OQ, and PQ) and how to write protocols and reports.

Learning Objectives:

  • Define the stages of the Process Validation Life Cycle
  • Discuss what data should be included in the protocols/reports
  • Analyze recent regulatory citations on pertaining to Process Validation

Areas Covered in the Session :

What is Process Validation?

  • Regulatory Requirements
  • Key Definitions
  • The Stages of Process Validation

Process Validation Implementation

  • Installation Qualification
    • Drafting the Protocol, Data Gathering, Writing the Report
  • Operational Qualification
    • Drafting the Protocol, Data Gathering, Writing the Report
  • Performance Qualification
    • Drafting the Protocol, Data Gathering, Writing the Report

Case Studies

  • FDA 483 Citation Review
  • Warning Letter Review

Who Should Attend:

  • Research and Development Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Documentation Departments
  • Validation Teams

Course Director: DANIELLE DELUCY ‎

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet Regulatory compliance.

Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.

Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection.

Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.