FDA Compliance
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Sunshine Act Reporting – Clarification for Clinical Research
This webinar will summarize the Sunshine Act or Open Payments Program requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and investigators. The Sunshine Act or Open Payments Program requires manufacturers of... -
Sunshine Act Reporting – Clarification for Clinical Research
This webinar will summarize the Sunshine Act or Open Payments Program requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and investigators. The Sunshine Act or Open Payments Program requires manufacturers of... -
Supplier Qualification – Important Part of Quality Systems and Supply Chain Management
This webinar is important to the industry as all the regulations require quality assurance of the materials, components, and services that impact or are used for the final product configuration. In addition, supplier qualification is a critical portion of... -
Supplier Qualification – Important Part of Quality Systems and Supply Chain Management
This webinar is important to the industry as all the regulations require quality assurance of the materials, components, and services that impact or are used for the final product configuration. In addition, supplier qualification is a critical portion of... -
Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration
Does your Supplier Quality remediation process resemble the very mess that it is trying to resolve? Receiving Inspection (RI) and First Article Inspection (FAI) may appear to be the beginning of the manufacturing process. In fact, they are the... -
Supply Chain Issues (21 CFR Part 820.50 and 820.80) and Warning Letters
The FDA Investigators are increasingly looking at the processes used by firms to qualify their suppliers, auditing levels applied to suppliers and service providers, the incoming inspection of the components, and the level of scrutiny of these controls, based... -
System Development Life Cycle (SDLC) Methodology and FDA-Regulated Systems
This webinar will discuss the System Development Life Cycle (SDLC) Methodology and the importance of following this approach when validating computer systems subject to FDA regulations. Upon completion of this session, attendees will have an understanding of how to... -
System Suitability Testing (SST) for USP and FDA Compliance
System suitability testing (SST) is required by USP, FDA and EP to check and ensure on-going performance of an analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by... -
Technical Writing for the Regulated Industries
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such... -
Test Method Validation to Verify your Device Performance
Test method validation is an often confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable,... -
The 510(k) Submission – Requirements, Contents, and Options
This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. This Medical device training... -
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The A to Z’s of Microbial Control, Monitoring and Validation of Water Systems
There are eight types of water used in manufacturing drug products. And, it is of paramount importance to design, validate and control water systems used in the manufacture of drugs, biologics and medical devices. This session is intended to... -
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...
