Cleaning Validation Simplified is a practical, 60-minute educational webinar designed for professionals who must ensure that equipment used in manufacturing, testing, and handling of regulated products is free from residues that may impact patient safety, product quality, or regulatory compliance.
Cleaning validation serves as a fundamental control in pharmaceutical, biotechnology, medical device, and related life science manufacturing processes, especially when facilities produce multiple products or potent compounds. This webinar focuses on eliminating complexity and providing a clear roadmap for implementing, maintaining, and troubleshooting an effective cleaning validation program.
At its core, cleaning validation is the documented demonstration that a cleaning process consistently and effectively removes residues to predefined, scientifically justified levels. These residues can include active pharmaceutical ingredients (APIs), detergents, excipients, microbes, endotoxins, allergens, and other contaminants that, if left on equipment surfaces, could cross-contaminate subsequent batches. Regulatory bodies such as the FDA, EMA, WHO, PIC/S, and ISO emphasize that cleaning processes must be validated when contamination poses a potential patient or product risk.
This training breaks down these requirements in a straightforward, non-technical manner, ensuring attendees understand why cleaning validation matters and how to execute it properly.
The webinar explains how to identify appropriate cleaning processes and how to establish acceptance criteria. Critical topics covered include selecting worst-case products, determining Maximum Allowable Carryover (MACO), and understanding risk-based health exposure limits such as Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE). Participants learn how to translate toxicological and pharmacological data into practical cleaning limits, including visual cleanliness requirements and the relationship between analytical test limits and cleaning criteria.
Sampling and analytical strategy is another central element of the presentation. Attendees explore how and when to use swab or rinse sampling, how to justify sampling locations, and which analytical techniques (e.g., HPLC, TOC, UV-Vis) are best suited for various residue types. The webinar explains method selection in plain language, emphasizing sensitivity, specificity, feasibility, and cost considerations. It also highlights common mistakes such as inappropriate swab recovery studies or reliance on visual inspection alone.
To support real-world application, the webinar walks participants through protocol development, execution of validation studies, training requirements, and documentation expectations. It demonstrates how to structure a cleaning validation protocol, how to qualify operators, and how to manage investigations, CAPAs, and change control. Lifecycle management is covered as well, including when cleaning processes must be revalidated due to equipment changes, process modifications, product changes, or cleaning agent updates.
Finally, the course highlights frequent pitfalls like overly conservative limits, lack of scientific justification, inappropriate sampling points, poor documentation, and failure to integrate validation into quality systems. Attendees leave with actionable guidance, simplified tools, and a clear understanding of how to implement a compliant, risk-based cleaning validation program without unnecessary complexity.
Why should you Attend:
Professionals should attend Cleaning Validation Simplified because it delivers clear, actionable guidance on one of the most misunderstood and frequently scrutinized areas of regulatory compliance. Cleaning validation directly affects patient safety, product quality, and the ability of a company to manufacture reliably without costly interruptions, cross-contamination risks, or failed inspections. Yet many organizations struggle with overly complex protocols, unrealistic residue limits, confusing sampling strategies, and documentation that fails to meet expectations. This webinar breaks down every element into practical steps that anyone can apply, regardless of experience level.
Participants will gain a strong understanding of how to establish rational limits, choose appropriate analytical methods, and design cleaning protocols that stand up to regulatory scrutiny from FDA, EMA, or other global authorities. The training also focuses on real-world decision making: how to determine when revalidation is necessary, how to respond to failures, and how to apply risk-based thinking when choosing worst-case equipment, products, or sampling locations. Attendees will leave with simplified tools, checklists, and frameworks they can immediately bring back to their workplace. Whether new to cleaning validation or seeking to streamline an existing program, this webinar offers the clarity and confidence needed to implement and maintain a compliant, efficient, and defendable cleaning validation strategy.
Areas Covered in the Session:
