ASTM 2500: Lessons Learned Through a Decade of Implementation

Why Should You Attend:

One of the most critical factors in manufacturing pharmaceuticals and medical devices is ensuring that equipment used for production is properly validated. Validation is required to demonstrate that equipment is fit for its intended use.

In recent years, there have been several standards and guidance documents created to discuss best practices for commissioning, qualification, and validation. One of these documents is the ASTM E2500 standard guide. Unfortunately, some of these documents are too vague and lack the details needed to provide adequate guidance and direction to the industry.

With limited guidance and experience, industry has been left to interpret how to adequately comply with the regulations. This course provides a comprehensive overview of the regulatory authority requirements and expectations for a compliant validation program and demonstrates how ASTM 2500 complies with those requirements.

Because of the tremendous effort expended in conducting validation studies, efficiency and documentation will be stressed throughout the discussion.

This course will provide a thorough review of regulatory guidelines on validation. Each element required to have a complete and thorough validation will be discussed in detail to ensure course attendees have a clear understanding of each requirement.

Areas Covered in the Webinar:

• Regulatory Requirements for a Compliant Validation Program
• FDA
• EU
• ICH Q7
• ICH Q8: Pharmaceutical Development
• ICH Q9: Quality Risk Management
• Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
• What is ASTM 2500
• Definition
• Concept
• Requirements
• Differences from traditional validation approach
• Real World Examples of ASTM 2500 Implementation
• Lessons Learned

Who Will Benefit:

• Operations
• Quality Assurance
• Quality Engineering
• Validation
• Engineering

Kelly Thomas
Vice President, Americas Quality Operations

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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