This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software […]

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 […]

This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative documents, the DMR and DHR. It will consider the European Union’s MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents’ differing purposes / goals, as […]

During this webinar our presenter will guide you through the best practices in drafting a technical and business governance program and also defining Research and Development for successfully implementing steps for site transfer. We will cover the best practices in transferring the scientific technology needed to manufacture the product, methods by which you could ensure […]

The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. […]

This webinar will provide an understanding of the structure of both US and EU regulatory bodies. The regulatory content common to all regulations will be addressed to create a foundation for understanding the basics of medical device compliance regulations. We will then discuss the meaning of regulatory compliance from both an internal – company, and […]

This seminar will help attendees with the fundamentals and best practices for investigating deviations. It will focus on using facts and objective evidence to arrive at root cause and CAPA. To accomplish successful deviation investigations this course will focus on how to avoid the drawbacks that may occur during FDA inspections. We will also discuss […]

Accuracy, the ability of a methodology to give results within acceptable limits when compared to known values, is a fundamental and key requirement. Calibration is the most common approach to obtain accuracy. Accuracy requires a comparison to a validated material. The level of confidence depends on traceability, a chain connecting the samples of interest all […]

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN […]

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA. Failure to adequately implement Production and Process Controls (P&PC) can lead to […]