Live Webinars

This interactive webinar by industry expert – David Nettleton will explain how to avoid FDA 483s by proper configuration and validation of GxP compliant spreadsheet applications. This webinar will help you follow the step-by-step instructions in real time as we configure Excel for audit trails, security features, and data entry verification. You will get a […]

Equipment qualification and process validation is a cumbersome activity if realistic but compliant approach is not applied. This session should help responsible personnel and teams to apply efforts in right direction to ensure regulator satisfaction at the same time help company operationalize full potential of both process and equipment/system. Lack of adequate qualification or validation […]

This seminar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report […]

Out of Specification (OOS) Test Results presents a major challenge to several in house and contract testing laboratories as FDA and other regulatory agencies’ expectations in this area are very rigid and specific. Successfully interpreting regulatory expectations in this area and practically dealing with OOS results for pharmaceutical, cosmetic, Vitamins, minerals and supplements and medical […]

The regulation and control of new drugs for sale in the US is based on the NDA and the IND development and clinical process. Manufacturing of drugs must be under the Drug cGMPs, 21 CFR 210/211. For decades, the regulation and control of new drugs in the United States has been based on the New […]

Design of Experiments (DOE) is an important technique for root cause analysis (RCA) and process improvement. As an example, when potential trouble sources are identified from a cause and effect diagram, DOE can be used to determine which of the factors are likely to be important. DOE can also develop quantitative models of the nature […]

Attend this training to learn how to implement a Human Error Reduction Program at your site. It includes practical tools and explains how to measure effectiveness to continuously improve human reliability at your site. Why You Should Attend: If you work in the GMP regulated industry you not only need to address human error deviations […]

In the pharmaceutical world, the term “quality” has several definitions. Generally speaking, quality means the product is fit for its’ intended use, is free from defects, and meets or exceeds customer expectations. The general public assumes manufactured pharmaceutical products are safe, efficacious, and have the correct identity. The Quality Control and Quality Assurance units within […]

One of the most useful analytical methods for cleaning validation studies is Total Organic Carbon (TOC). This includes the design, qualification and routine monitoring of the manufacturing process. While there does exist some confusion within the industry and regulatory bodies about the use of this analytical technique, it is widely used because of its assured […]

This course is intended to provide specific guidelines for coaching attendees in the concepts of 21 CFR Part 11, namely the FDA requirements for using electronic records and electronic signatures (ER/ES), and the best practices for implementing these technologies in a regulated environment. The use of electronic records and signatures enables a company to conduct […]

When developing the quality audit, there are a number of requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. This webinar is designed to provide the participants a working knowledge of quality audits. The why, when, who, how, and what of conducting a […]

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps […]