Medical Device Documentation and Data Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

This course will instruct attendees on establishing an approach to process control within each unit of operation to generate overall process control needed for validation. The webinar instructor, an FDA expert, will enumerate the importance of variation in enhancing a validated means of operation and the parameters that can cause variability. The Randomized Block statistical model will also be analyzed for effective validation.

This FDA compliance webinar will discuss in detail the guidance on recognition and use of consensus standards. It will focus on the topics such as voluntary conformance, declaration review and content of declaration of conformity.

This webinar will provide clarification on which medical device facility or establishment must register and list, how to register and list, and how to coordinate the payment process to accomplish the actual registration or device listing.

This webinar will cover in detail the current Good Manufacturing Practices (cGMPs) regulations for pharmaceutical products. Attendees will learn how to comply with these FDA regulations and avoid pitfalls.

This EU filing and Registration webinar will discuss in brief all the new EU clinical directives, its Impact and how companies can effectively align their filing and registrations processes to effectively implement the requirements of the regulations.

This webinar will explain the principles of lean and value stream mapping. Attendees will learn how to apply lean concepts to continuous improvement work across the quality system.

This webinar will provide the typical elements required to be included in the Batch Production Record and the Device History Record in order to accomplish a quality and cost effective review and quality assessment based on current regulatory expectations.

This webinar on tobacco regulations will discuss FDA regulatory requirements for tobacco products. It will prepare you for FDA’s Deeming Regulations for cigars, pipe tobacco, electronic cigarettes, dissolvable tobacco and other novel tobacco products.

This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.

This webinar will discuss requirements for supplier and vendor qualifications. Attendees will learn how to develop a risk management plan for monitoring of suppliers, vendors and service providers. It will also discuss how to prevent recalls and advisory notices due to provided non-conforming materials or bad services.

This webinar will discuss in detail the FDA guidance on medical device recalls including its role, expectations and enforcement policy. It will cover key topics on medical device recall including recall classification, firm’s responsibilities for a recall, recall communication, recall strategy, FDA expectations and much more.

This 510(k) and risk management webinar will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstrate that product is safe.

This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.

This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.

This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.

This webinar will explain how to implement an Enterprise Resource Planning (ERP) system by integrating a company’s existing quality system. It will cover selection, analysis, initiation, design, validation and test phases, including change control.

This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.

This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.

The Webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

This mobile medical apps training will outline the regulatory requirements for medical device software development processes, and the requirements for submissions.