Best Practices for Implementing an Effective Cleaning Validation using Principles of Upcoming ASTM E3106

This webinar discusses implementation of Cleaning Validation programs based on global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. What makes this webinar special and unique is a very rare glimpse into upcoming ASTM E3106 for Cleaning Validation. This is a Risk-Based Science-Based Lifecycle approach guidance document that was fully vetted with industry as well as with FDA. It is a first guidance document in the last 25 years (since the FDA Guidance of 1993) and it is based-on elements of ICH Q8-11 and Process Validation Guidance. In addition, this webinar describes use of QRM (quality risk management) in Cleaning Validation and growing trend of applying this approach to lifecycle of product manufacturing process. Establishing of health based Cleaning Validation limits also discussed in this session. Additionally, recommendations on compliant and sustainable program will also be covered, as well as regulator's expectation for these programs.

Objectives of the Presentation

• Cleaning Process
• Cleaning Verification
• Cleaning Validation
• Risk Management
• Knowledge Management
• Qualification of CIP Equipment
• Health Based Cleaning Validation Limits
• ADE/PDE
• Critical Process Parameters
• Critical Quality Attributes
• Control Strategy

Why Should you Attend
If you are a professional who is involved in a development of pharmaceutical and biopharmaceutical products and processes’ cleaning procedures throughout the continuous lifecycle of drug products, this webinar is definitely for you. During this session we will discuss the Best Practices for Implementing an Effective Cleaning Validation that includes development of cleaning process programs and cleaning verification and validation programs. We will discuss regulatory validation guidance and show how quality risk management should be utilized in implementation of risk based lifecycle approach to cleaning validation. We will also touch upon a use of statistics in cleaning validation process and talk about continued verification/monitoring. We will concentrate on a risk based approach as it is a corner stone of cleaning process validation principals and practice using principles of upcoming ASTM E3106.

Areas Covered

• Cleaning Validation Guidance
• Establishing Health Based Limits
• Quality Risk Management
• Lifecycle Approach
• Cleaning Verification
• Continued Validation Monitoring
• Cleaning Analytical and Microbial Methods

Who will Benefit

• Validation
• Quality Assurance
• R & D
• Production
• Quality Control
• Microbiology
• Engineering
• Senior quality managers
• Quality professionals
• Production supervisors
• Validation engineers
• Process owners
• Quality engineers
• Quality auditors
• Analytical method development personnel
• Quality control and quality assurance personnel
• Pharmaceutical and biopharmaceutical industries

Topic Background
Cleaning Validation is a regulatory requirement as well as expectation. In addition, robust and compliant cleaning validation program makes perfect business sense for successful manufacturing facilities. Additionally, attendees and delegates will be provided glimpses of ASTM E3106 concepts.