As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting regulatory compliance requi ...
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. ...
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer syst ...
The COVID-19 pandemic has presented challenging wage and hour questions for employers. The federal Fair Labor Standards Act (FLSA)—and corresponding state wage and hour laws are not on hold during the pandemic. In addition to FLSA obligations, decisions regard ...
The Coronavirus may have brought much of the world as we know it to a temporary halt. Employment laws, and employers’ obligations, however, are not on hold. Employers still have an obligation to provide their employees a safe, workplace, free of harassment a ...
In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can a ...
This course will explain the changes relating to Form 1099-MISC for 2020, in particular the changes to how contract labor pay is reported. The IRS has created a new form, called Form 1099-NEC, where contract labor pay will be reported. We will cover these chan ...
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most im ...
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR ...