Medical Devices
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Big Data in FDA-Regulated Industry – Best Practices for Systematic Use
In recent years, big data and information is available in public domain. Adequate use of such big data in FDA-regulated industry has become critically important to exercise best practices. In this presentation, the speaker will provide a great opportunity... -
Biopharmaceutical Analytics – Regulations and Validation
Biopharmaceuticals and traditional pharmaceuticals drugs have completely different approach to how they are produced. Biopharmaceuticals use living organisms such as bacteria, yeast and mammalian cells to manufacture drugs, whereas traditional pharmaceuticals are manufactured through a series of chemical synthesis.... -
Blockchain Innovations that Connect and Protect the Supply Chain
This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain. The focus will be on how this can enhance cMGP compliance while it strengthens a company’s... -
Bringing Risk Based processes into your SDLC
Risk Assessment is now an underlying principle in global regulatory compliance, appearing in both governmental, i.e., FDA, EMA and non-governmental standards such as ISO. Gain an understanding of how, when and where to apply risk assessments to IT compliance... -
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Building a Compliant Documentation and Training System
This 60 minutes webinar will give a better understanding of the relationship between compliance, documentation, and training. It will provide participants with the ability to effectively meet regulatory requirements, properly integrate training into their quality system, and develop effective... -
Building a Compliant Documentation and Training System – 3 Hours Virtual Seminar
Writing effective Standard Operating Procedures and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute. Knowing the most effective and... -
Building a Compliant Documentation and Training System – 3 Hours Virtual Seminar
Writing effective Standard Operating Procedures and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute. Knowing the most effective and... -
Calculations for Process and Product Capability
Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees... -
CAPA Simplified – A one-form, easy-to-complete, method for simplifying your CAPA Process
This CAPA evaluation, implementation and integration webinar will discuss FDA regulatory requirements, how to evaluate your CAPA system, how to integrate with QMS and the best practices approach to initiation, evaluation and implementation of CAPA system along with discussion... -
CAPA Training related to FDA Causal Warning Letters
The number one citation for the FDA 11 years running has been the issue of CAPA control and resolution. It was barely surpassed recently by Product and Process Control (P&PC) because of the inherent technology boom and the reduction... -
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
When there is a need to make some change to an environment and/or resolve a problem, we must think about a project that could implement the necessary change and address the problem. But we can’t just run our project... -
CE Marking – EU Compliance Under MDD
This CE marking training will discuss the recent changes to MDD (Medical Device Directive), how to identify non compliance areas, contents of the technical file and essential requirements document and how to select notified bodies for MD compliance. Why... -
CE Marking in the EU – Latest Regulations
The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA). CE marking is required for many products. CE marks: Show that the manufacturer has checked that their products meet... -
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Cleaning Validations Using Extraction Techniques
Medical device manufacturers have always been under scrutiny to ensure that their product does no harm to the patient. Regulatory agencies have become increasingly aware of the potential dangers of residual manufacturing materials on medical devices. Therefore, cleanliness has... -
Clinical Project Management
GCPs are required to be followed during conduct of clinical trials; it is the responsibility of the sponsor to ensure that all aspects of the study comply with legal and regulatory requirements to ensure integrity and reliability of the... -
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Clinical Trials for The Intended Use of Software as a Medical Device
The FDA regulates standalone software as a medical device (SaMD) that is used for medical treatment or diagnostic applications. The clinical impact and corresponding risk associated with the use SaMS must incorporate a number of cross matching factors. Applying...
