FDA Compliance
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Writing Effective Analytical Procedures
Effective documentation of analytical procedures is essential to ensure that testing required by regulatory agencies is performed correctly and consistently. This webinar will cover some of the common mistakes made while writing analytical procedures, and will give examples of... -
Writing Effective SOPs for Medical Device Quality Management Systems
The FDA expects Medical Device manufacturers to “establish and maintain procedures”. You will learn what this means and how to comply with expectations. This webinar will help you ensure that your SOPs (Standard Operating Procedures) are complete, concise, and... -
Writing Effective Standard Operating Procedure (SOPs) and Work Instructions (WIs)
Standard Operating Procedures – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions... -
Writing Followable Procedures – Avoid Procedure Related Deviations
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start... -
Data Governance for Computer Systems Regulated by FDA
Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realize value from it, minimize the cost,... -
Good Documentation Practices
“Good documentation practices” is a “current” industry practice that is reviewed and cited by federal regulators when audited. Pharmaceutical/Biological document are legal documents that are controlled by all regulatory agencies. The person or persons responsible for filling out these... -
Assessing FDAs Proposed Changes to the 510(k) Process
“Description : This webinar will discuss in detail, the latest FDA’s proposed changes to the premarket notification process, 510(k) Since September 2009, the Center for Devices and Radiological Health has been reviewing the operation of the 510(k) program and... -
Proactive Internal Auditing-The Key to Establishing, Maintaining, and Improving Quality Systems
“Description : This webinar provides a broad overview of the internal auditing functions starting with the concept of quality systems and their objectives, primarily using graphical methods. The webinar focuses on the role of the internal audit function throughout... -
Assessing FDAs Proposed Changes to the 510(k) Process
“Description : This webinar will discuss in detail, the latest FDA’s proposed changes to the premarket notification process, 510(k) Since September 2009, the Center for Devices and Radiological Health has been reviewing the operation of the 510(k) program and... -
Complaint Handling & Medical Device Reporting (MDR)
Description: As a domestic or foreign medical device manufacturer including an importer and user facility, you are subject to regulatory requirements for complaint handling and medical device reporting (MDR) in the US. FDA frequently cites in 483s upon establishment... -
Cyber Security Planning for Medical Devices
Description: How you manage cyber security issues for medical device software raises serious concerns at FDA. Software is subject to a number of FDA requirements, such as the Quality System Regulation design control requirements. In adequate cyber security measures... -
Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements
Description: This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now, the... -
ISO 13485:2016 – Proposed Changes to the International Medical Device Standard
Description: ISO 13485:2016 – Are you prepared to understand and implement the changes being finalized by the ISO technical committee for the long awaited update to the medical device standard ISO 13485:2003?. Awareness of the upcoming key requirements and... -
FDA 510(k) Requirements, Submission, and Clearance: Best Practices
Description: This presentation will walk you through how to prepare and submit a traditional premarket notification for successful clearance from US FDA. The premarket notification is the most common pathway to market for medical devices including in... -
Good Preparation Practices for FDA and Notified Body Audits
Description: Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes leading to 483s and even warning letters. This webinar can help you be more professional and polished during an inspection. You... -
FDA’s New eMDR Requirements
Description: Manufacturers and importers must report adverse events associated with a risk to health or death. Until now, the reports were submitted in hardcopy using MedWatch form 3500A. Managing the volume adverse event reports for industry and the FDA...
