Live Webinars

Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize the product defects and also the risks […]

This seminar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical in order to develop the appropriate strategy, policies and procedures to ensure compliance. This webinar will also benefit […]

IEC has released a new medical device usability standard, IEC 62366-1:2015, “Usability Engineering in IEC 62366-1:2015 —  Part 1: Application of the new Usability Engineering Standard to Medical Devices” and “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Its 9 Stages provide a repeatable process for performing UE and […]

This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint handling and product recalls. The course will also include timeline requirements associated with adverse event reporting. This webinar will describe […]

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 […]

Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM. Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions. In addition they will be able to identify key QRM terminology and recognize the four (4) […]

Data are central to the development, manufacture and marketing of pharmaceuticals of all types. The renewed interest in data integrity raises questions regarding what is data integrity and how to assess it. Lack of data integrity comes in two forms: purposeful manipulation of the data to deceive and the inadvertent problems that occur in the […]

How would you approach a non-conformance in the laboratory? Do you start treating the symptoms right away? Or, do you take a moment to analyze and consider if there’s actually a deeper problem that needs your attention? Root Cause Analysis (RCA) is one of the most commonly used techniques that helps people answer the question […]

Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of […]

Data, data everywhere. In today’s world, we have access to tremendous amounts of data. Yet, it is difficult to translate this data into useful information. Translating data into meaningful information is a capability that can be a competitive strength in improving quality and compliance. Data Management and Quality metrics can help you with forecasting, resource […]

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 […]