FDA Compliance
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The DIOM – A Straightforward Method for Meeting FDA Requirements for Design Inputs and Outputs
This webinar will provide valuable insight to design assurance and quality assurance engineers looking to simplify or condense design development activities into one document for easier traceability. This webinar is also ideal for startup companies who are unfamiliar with... -
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The FDA 510(k) and Q-Submission: Best Practices
This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss how to put together a... -
The FDA Inspection Process – From SOP to 483
This FDA Inspection process training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Does the FDA call in advance or just show... -
The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 – Key Strategies to implement proper Transition
The new EU In Vitro Diagnostics Regulation is not all that new or very different from the original 20-year old In Vitro Diagnostics Directive. That’s the good news. The bad news : there will be a significant amount of... -
The Master Validation Plan – The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971... -
Through the Eyes of an Auditor
Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally,... -
Tobacco Industry Trends for Computer Systems Regulated by FDA
Get an overview of the regulations as they pertain to the manufacturing, marketing, distribution and other operational activities engaged by companies in the tobacco industry. This course will describe the best practices for developing a compliance strategy, including roles... -
Top Process Validation Mistakes – And How to Avoid Them
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes.... -
Top Process Validation Mistakes – And How to Avoid Them
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes.... -
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... -
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... -
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... -
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... -
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.... -
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...
