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Validity : 29th May'23 to 08th Jun'23
Overview of design control for medical devices with and emphasis on verification and validation of design inputs. Webinar will cover basic regulations regarding verification/validation of inputs, trace of inputs to verification/validation and techniques includ ...
Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, they have the ability to change behavior, drive quality culture and improve both individual and company performanc ...
If you work in the GMP regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization ...
Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain the status of high-performing organization manufacturing sites are implementing strategies and practices like ope ...
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though Training is considered the “vaccine for mistakes,” Training is as good as its ef ...
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing d ...
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, ...
The most crucial factor to achieve Business Growth in Pharma manufacturing nowadays, is Compliance with GMP norms, so as to increase the technical and financial strength of Manufacturing units. Currently, the aspect focused on by most Auditors, both internal, ...
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 sys ...
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System.Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed.More importantly,well writt ...