This pack consists of 5 webinars:-

Why People Make Mistakes. Understanding Human Error

Human error is about human behavior. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented once we understand the factors and causes of these events. From procedures, training, and workplace environments many variables that affect human behavior CAN be controlled to reduce the likelihood of these occurrences. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and/or fixed.

FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

A successful audit is dependent on understanding what we could expect from regulators. This can be observed by looking at the focus of recent inspections within the industry. Such case studies will help companies to analyze their own practice and address similar issues in advance. This ensures we will be better prepared for an FDA audit resulting in fewer errors. This 90-minute online session will focus on the changes in FDA Audit Practices and the current method used to determine audit frequencies by using a system of risk assessments. The word – “AUDIT” creates anxiety for the pharma, biotechnology, and medical devices industry. This intensifies if you are unaware of how your company’s practices and procedures compare to the rest of the industry.

Pharmaceutical Compressed Air – Quality GMP Standards and Requirements

Compressed air is often overlooked as a potential source of clean room and product contamination.  This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed air system with its individual components is provided.  Engineering schematics are included.  All component functions are detailed with recommendations as to which component type is considered optimal. Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system are essential for maintaining a quality system without contamination of the product.

FDA’s Scrutiny Of Social Media Off-Label Promotion

FDA’s regulation of social media operates as a moving target. What is OK or not OK remains vague, perhaps purposely so. All social media platforms provide an easy common way to cross the FDA’s legal boundaries for “misbranding” your product, whether knowingly or unknowingly. FDA regulates how firms advertise and promote their products in social media, which creates a tricky regulatory risk of enforcement action when firms step over FDA’s somewhat mysterious advertising and promotion boundaries.

Human Error Reduction in GMP Manufacturing

This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.