Cleaning Validation Made Easy : Basic Concepts of Cleaning Validation

Why Should You Attend:

Regulatory body citations (FDA warning letters, 483 Observations etc) on the subject on cleaning validation has been a never-ending story of audit findings due to the lack of understanding of basic concepts of cleaning validation or nonchalant attitude towards this aspect of validation. Without a robust cleaning validation program, manufacturing operations and/or schedules can be negatively impacted if major cross contamination issues are prevalence in the routine manufacturing processes. The continuous disruption of manufacturing operations could subsequently lead to loss in revenue due to fines associated late product delivery to market and/or clients as well as inability to make and sell products due to halted manufacturing operations associated with such major citations. Therefore, gaining knowledge and understanding in the basic concepts of cleaning validation and knowing how to apply them, could be a major turning point for a firm that has been plagued with ongoing citations association with cleaning validation.

Cleaning validation has been misconstrued over the years basically due to lack of understanding of the cleaning validation concepts. Cleaning validation is predominantly associated with processing equipment involved in drug manufacture and not the room or environment in which the product is made, consequently delineating cleaning validation from environmental monitoring. Additionally, the cleaning validation program can be designed in a cost-effective way with better understanding of the concepts like DEHT, CEHT, TACT( cleaning steps) as well as a clear understanding of product and cleaning agent chemistry.

Attending this webinar will highlight on the “what”, “why”, “when”, “who” and “how” elements of cleaning validation to facilitate the better cleaning validation program design for success. Attendees will gain a better understanding of cleaning validation concepts and know how these concepts fit into the design of robust and effective cleaning validation program to satisfy both company’s quality compliance objectives and regulatory body standards.

Areas Covered in the Webinar:

• Cycle Development
• Cleaning SOP
• Dirty Equipment Hold Time (DEHT)
• Clean Equipment Hold Time(CEHT)
• Campaign Length
• Periodic Monitoring Program
• Sampling Techniques (Swab & Rinse Samples)
• Continued Process Verification
• Critical Process Parameters
• TACT ( Time, Action, Concentration, Temperature)
• Analytical Test Method

Who Will Benefit:

• R&D Scientists and/or Technicians
• Process Development Scientists / Technicians
• Technology Transfer Technologist
• Validation Personnel
• Manufacturing Operation Group Leader/ Supervisors
• Quality Assurance Team Leads

From the following industries:

• Biologics, Pharmaceuticals, Vaccines, Medical Devices etc.

Free Materials:

• FDA 2011 Process Validation Guideline
• Technical Report # 29: Points to Consider for Cleaning Validation
• Technical Report# 49: Points to Consider for Biotechnology Cleaning Validation

Victor Olatundun
Management Consultant, Validant

Victor Olatundun is a pharmaceutical professional with 25 years expertise in the field of validation, technology transfer, management consulting and quality system remediation strategy in the biologics and pharmaceutical industry. He possesses strong leadership and management skills coupled with strong technical expertise, process knowledge and understanding in the field of validation and manufacturing operations. Additionally, he possesses both hands-on expertise and a strategic view of all aspects of the validation relating to process, cleaning, shipping and commissioning & qualification projects.

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