Course Description

Understanding the Process Validation Life Cycle

Online On Demand

Course Offering 1706902O2759A
Course ID 2759

In-Person Course

Who Should Attend?
This online training will benefit professionals in the following industries: Pharmaceutical, Biotechnology, Medical Device, Chemical Processing, Food, Cosmetics, and Biologics

Potential job functions that would apply include: Engineers, Chemists, Scientists, Formulators, Documentation Specialists, Auditors, Managers, Technicians

In departments such as: Manufacturing, Operations, QA/QC, Engineering

Course Description
This 90-minute, accredited 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.

Course Director
Danielle DeLucy, MS; Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, MS, is currently the owner of ASA Training & Quality Consulting, LLC, an Independent Consultant Agency to the Biologics and Pharmaceutical Industries specializing in the areas of Quality Assurance and Quality Systems. Prior to this role, Ms. DeLucy has been in the industry for 18 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. Ms. DeLucy 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, Ms. DeLucy assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.