Attendees will also receive an Excel spreadsheet with the d*2 factors that are required for the average and range method, and another with data for the worked examples. These appear in some references that are named in the handout, but they are not as widely available as the traditional control chart factors. The handout notes […]

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process and validating the effectiveness of the studies will be explained. The various types and methods […]

This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy. This review will help bridge the gap […]

Validation is an essential element of the Quality System Regulations and ISO 13485. This course dwells into the processes that need to be validated and what steps are needed to validate the processes. You’ll also learn the essentials of validation planning, protocol writing, and change management. We’ll take a deep dive into all the steps […]

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 […]

Instrumental gas chromatography as an analysis is widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an […]

Objectionable microorganisms associated with a medical device or pharmaceutical product can cause a serious illness to a patient. By testing and identifying these mircoorganisms early in the manufacturing processes, controls can be put into place to prevent harm to the patients. Objectionable microorganisms are considered, if discovered, harmful to the patients. By identifying and controlling […]

This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. They will learn how to establish an effective process validation system and integrate it with other systems such as Risk Management, Corrective and Preventive Action and Supplier Management. Participants will learn how […]

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 […]

Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting […]