On Demand Webinars
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Train-the-Trainer Toolbox: How to Prepare & Deliver Engaging & Interactive Training Programs
Does your organization utilize in-house trainers? Do these trainers lack the program development and delivery skills they need to be successful? In this program, Judi turns your employees into professional trainers. They’ll learn how to gear training to their... -
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Training in Human Error: Reducing Training Related Errors
We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program. Why You Should Attend Training programs have evolved through time. Human reliability or human error... -
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Training Requirements under FDA’s Quality System Regulation
Training requirements can make or break a firm’s compliance program. A weak training program becomes a weak link in a firm’s ability to make a product that conforms to FDA requirements. An effective training program should enhance and ensure... -
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Transfer of Analytical Methods and Procedures according to USP 1224
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected... -
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Transfer of Analytical Methods and Procedures according to USP 1224
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected... -
Recording
Transforming Your Quality System from Reactive to Proactive
Predictive Compliance will help you identify, investigate, and communicate compliance issues within your organization. This webinar will help you identify and articulate risks in a predictive manner resulting in a more efficient and effective Quality Management System. Almost daily... -
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Transforming Your Quality System from Reactive to Proactive – Predictive Compliance
Predictive Compliance will help you identify, investigate, and communicate compliance issues within your organization. This webinar will help you identify and articulate risks in a predictive manner resulting in a more efficient and effective Quality Management System. Almost daily... -
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Transition to ISO 9001:2015 with Confidence
The publication of ISO 9001:2015 and its impact on many related industry-specific standards will present a unique opportunity for organizations to evaluate and improve their existing QMS. With the publication of ISO 9001:2015, organizations now face the next steps... -
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Transition to ISO 9001:2015 with Confidence
The publication of ISO 9001:2015 and its impact on many related industry-specific standards will present a unique opportunity for organizations to evaluate and improve their existing QMS. With the publication of ISO 9001:2015, organizations now face the next steps... -
Sale! Recording
Transition to ISO 9001:2015 with Confidence
The publication of ISO 9001:2015 and its impact on many related industry-specific standards will present a unique opportunity for organizations to evaluate and improve their existing QMS. With the publication of ISO 9001:2015, organizations now face the next steps... -
Recording
Transitioning Assays from Different Technologies – Validation and Qualification
This 1-hr webinar will help you understand the steps that must be taken when transitioning assays between different technologies. It will make sure you have a full understanding of the legacy technology and the current technology and develop a... -
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Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body... -
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Trial Master File Requirements and Essential Regulatory Documents
Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.... -
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Trimming Back the Burden of FDA’s Software Regulation
Changes in the FDA’s regulation of software makes life a lot easier for medical device manufacturers. FDA faced an overwhelming challenge when it started to develop a regulatory program beyond the basic Quality System regulation and the Software Guidance... -
Sale! Recording
U.S. FDA New Draft Guidance on UDI Label Form and Requirement
The U.S. FDA is well into their long-anticipated Unique Device Identification System. Its purpose is to “establish a system to adequately identify devices through distribution and use”. It requires the development of a unique device identifier (UDI) in plain... -
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U.S. FDA’s 510(k), IDE, and PMA Documentation, Submission and Approval Process
What are the various routes to US FDA device clearance / approval? The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through...