Ethylene Oxide and Gamma Radiation Sterilization Validations

Description:

Review a company's Sterilization V&V. First, the Master Validation Plan, evaluating its elements against ISO 14971 / ICH Q9 for hazard analysis and product risk management. The sterilization plan: 1) the sterilization process / equipment, including software, V &V; the 2) the specific product / load configuration V&V. Consider IQ, OQ, PPQ and MPQ, where needed. Achieving the required SAL. Developing the system for your products. What's needed for the annual review and any additional V&V? Where does Part 11, cybersecurity and software VT&V fit?

Why Should You Attend:

Some of the most important V&V's for medical products is sterilization validation. They are also among the most expensive. It's important to get them right for many reasons, especially patient safety. What are the regulatory and documentation requirements? How does risk-based safety V&V planning / execution function and how documented per ISO 14971 and ICH Q9? This webinar look at the entire V&V process and will present several Test Case formats and Test Report / Protocol examples in harmony with ISO 11135 (EO) and ISO 11137 (Gamma).

Areas Covered in the Webinar:

Participants will learn how an effective Verification and Validation plans/systems for test methods, equipment, process, cleaning, and sterilization are a critical requirement to the movement toward a risk-based approach to compliance and product safety.

Issues to be covered include:

• Equipment, process, cleaning, bioburden, sterilization V&V

• ISO 11135 and 11137 validation requirements

• Basic CGMP requirements

• Initial issues
• Develop the various V&V test cases and Report formats

• The successful sterilization validation

• The Annual Review / Validation

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their sterilization Validation Planning and Execution / Documentation. These principles apply to personnel / companies in the Device, Pharmaceutical, Diagnostic, and Biologics fields and Combo products. The employees who will benefit include:

• Senior management
• R&D
• Quality Assurance / Regulatory Affairs
• Production
• Engineering, including Software
• All personnel involved in EO or Gamma Sterilization verification and/or validation planning, execution and documentation.

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 43 years experience in U.S. FDA-regulated industries, 18 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, 6 chapters in the two RAPS validation text books, conducted workshops and webinars worldwide on US FDA regulatory issues. John is a graduate of UCLA.

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