Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Join us for a webinar on September 08 for a discussion of the webinar 

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.

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

Webinar Takeaway

Module 1: What is Process Validation?

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

Module 2: 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

Module 3: Case Studies

  • FDA 483 citation review
  • Warning Letter review

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

Can't Make this LIVE Webinar?

Simply select the Recorded option when registering and we will send you the link to view the recorded version.

Who will Benefit

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

Industries who can attend

This 90 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Faculty Danielle DeLucy

Faculty Danielle DeLucy

Danielle DeLucy, MS, is currently an independent consultant 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 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.

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