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 […]

There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include: water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, and the general manufacturing environment. As such, there is no one size fits all investigation. Microbiological testing covers a wide range of […]

This webinar will show you how to check for normality in your data and apply transformations to non-normal data. Many of the commonly used statistical tests and calculations of chart limits (or other measurements) require that the data be “normally distributed”. Learn the theory and concepts of determining when a normal distribution is needed, how […]

This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples. Laboratories are often confused about the uncertainty of measurement (MU). Further ambiguity on the subject arises as to: What is needed […]

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 3-hour webinar will cover the basics of design controls for medical devices. Design Controls are […]

Pharma companies use Learning Management Systems (LMS) as vital tool for demonstrating to regulatory authorities that they are maintaining and ensuring their staff training efforts are up-to-date. Most LMS systems frequently claim unlimited functionality and scalability but have limitations that companies should be aware of in order for them to overcome and be able to […]

The webinar reviews the general concepts and basic elements of pharmacokinetics. The webinar will describe the processes that a drug undergoes after administration such as the absorption (when not administered intravenously), the distribution, including plasma protein binding, the metabolism (the biotransformation of the drug into its metabolites) and the excretion (via the bile in faces […]

Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal and external GMP audits in order to find and correct areas where sites are not in full compliance with the GMP regulations before an FDA audit occurs. By providing proper tools and techniques to […]

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 […]

The effective and progressive use of a Screening DOE, a Mapping DOE and a Robust Process DOE will lead to a better understanding of the process and the location of the best optimum. NOTE: This webinar does not focuses on statistical methods, analysis of variance, and other techniques, but rather focuses on DOE strategies and […]