WEBINARS

 

Stability and Shelf Life of Medical Devices

webinar-speaker   Stephanie Cooke

webinar-time   90 Min

Product Id: 705485

This webinar will cover all relevant regulatory requirements (CFR, FDA, ISO, ASTM and European) for establishing the stability and determining the shelf-life of medical devices. Attendees will gain a better understanding of the design control process for designing medical devices.

Recording Available

 

HIPAA for Medical and Dental Offices

webinar-speaker   Kelly D Ogle

webinar-time   60 Min

Product Id: 705421

The webinar will discuss the critical elements of HIPAA Privacy and Security Rule including the updated changes to the Final Rule. It will also provide best practices for the personnel in medical and dental offices to ensure compliance with HIPAA regulations.

Recording Available

 

Compliance Department Restructuring with the New Regulatory Demands

webinar-speaker   Carlo Chalhoub

webinar-time   60 Min

Product Id: 705454

This webinar addresses recent changes in the compliance environment. It will also discuss the process for evaluating compliance department structure and the goals of compliance restructuring.

Recording Available

 

Is your Export Control Program Up to Standard? A How-to on Conducting a thorough Self-Assessment

webinar-speaker   Suzanne Bullitt

webinar-time   60 Min

Product Id: 703205

This training on Export Administration Regulations (EAR) compliance will provide the attendees best practices for developing an export control program for conducting a thorough self assessment.

Recording Available

* Per Attendee $149

 

Transaction Monitoring and Cybersecurity - DFS, SOC, Cybersecurity Framework and Many More

webinar-speaker   William Akel

webinar-time   60 Min

Product Id: 705365

Attend this webinar to understand the best ways to maintain annual compliance with DFS cybersecurity requirements through a strategic transformation of IT security monitoring to proactive cyber risk management; and to learn how a human-centric security orchestration model with people, process and technology will save and make you money.

Recording Available

 

How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance

webinar-speaker   Edwin Waldbusser

webinar-time   60 Min

Product Id: 705057

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.

Recording Available

* Per Attendee $249

 

Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 700184

This webinar on selling medical devices in the European Union (EU) will immensely benefit companies wishing to penetrate the EU market for medical devices or sharpen their skills. It will provide practical guidance on achieving the CE mark. Medical devices sold into the European Union (EU) must comply with the applicable medical device directives and EU laws similar to FDA’s regulations.

Recording Available

* Per Attendee $249

 

HIPAA Updates and the Omnibus Rule

webinar-speaker   Jay Hodes

webinar-time   90 Min

Product Id: 705181

Understand the HIPAA Omnibus Rule requirements and make sure your HIPAA compliance program is adequate and can withstand a government audit or investigation.

Recording Available

* Per Attendee $179

 

Develop a Device Master Record that can assist with Device History Record Review

webinar-speaker   Mary Nunnally

webinar-time   60 Min

Product Id: 705328

This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.

Recording Available

 

Engaging Hospitalists in the Case Management Process

webinar-speaker   Bev Cunningham

webinar-time   60 Min

Product Id: 705411

This webinar will focus on methods to ensure best-practice strategies for aligning the case management department with hospitalists’ practices. Attendees will understand the role of the hospitalist, the hospitalist group and the collaboration responsibility with the case management department—RN case managers, social workers and leadership.

Recording Available

 

Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance

webinar-speaker   Sarah Fowler Dixon

webinar-time   60 Min

Product Id: 705451

This webinar will provide an understanding of the data integrity and data lifecycle within the GxP environment. Attendees will learn best practices to comply with the current regulations and industry standards for electronic data integrity throughout the data lifecycle.

Recording Available

 

Texting and E-mail with Patients - Meeting Patient Desires Within the HIPAA Rules

webinar-speaker   Jim Sheldon-Dean

webinar-time   90 Min

Product Id: 702854

This HIPAA compliance training will explain how HIPAA requirements for privacy and security can be reconciled with patient requests for information to be provided by e-mail and text messages.

Recording Available

* Per Attendee $179

 

OSHA for Medical and Dental Offices

webinar-speaker   Kelly D Ogle

webinar-time   60 Min

Product Id: 705416

This webinar will discuss the most frequently found safety hazards in medical and dental offices, the OSHA requirements and standards that apply, and how to ensure compliance.

Recording Available

 

Laboratory Accreditation and Quality Management Systems Part 2: Technical Concerns

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 705299

This laboratory accreditation training program will focus on technical components of Quality Management System (QMS) including accommodation and environmental conditions, test and calibration methods, equipment, measurement traceability, sampling and much more.

Recording Available

 

Equal Employment Opportunity (EEO) Beyond the Basics: Key Concepts and Principles

webinar-speaker   Mary Gormandy White

webinar-time   60 Min

Product Id: 705483

This webinar will focus on what supervisory and HR professionals at all levels need to know about EEO regulations and requirements, including protected characteristics, workplace harassment, retaliation and more.

Recording Available

 

HIPAA and BYOD - Portable Devices and Enforcement

webinar-speaker   Jim Sheldon-Dean

webinar-time   90 Min

Product Id: 703822

This training session will discuss the requirements, the risks, and the issues of the increasing use of mobile devices for patient communications and provide a road map for how to use them safely and effectively, to increase the quality of health care and patient satisfaction.

Recording Available

* Per Attendee $249

 

The Past Isn't in the Past: Effecting Sound Employment Background Checks

webinar-speaker   Jacquiline M Wagner

webinar-time   60 Min

Product Id: 705489

This webinar will discuss the various laws covering background checks, common types, requirements for conducting background checks and more. It will also provide best practices to ensure compliance with the regulatory requirements.

Recording Available

 

Drug Product Performance, In Vivo: Bioavailability and Bioequivalence

webinar-speaker   Leon Shargel

webinar-time   90 Min

Product Id: 705461

This webinar will discuss the basic concepts of bioavailability and bioequivalence and their relationship to drug product performance, in vivo. It will also provide practical examples to show how bioavailability and bioequivalence studies can be applied to drug product development.

Recording Available

* Per Attendee $249

 

Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs)

webinar-speaker   Stephanie Cooke

webinar-time   90 Min

Product Id: 705486

This webinar will cover ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API). Attendees will gain a deeper understanding of the importance of GMPs for APIs, apply these principles in their current roles in order to better manage quality, make improvements, solve problems and make decisions.

Recording Available

* Per Attendee $179

 

ECCN & CCL - Classification, Exceptions, Documentation, License Requirements & More

webinar-speaker   Suzanne Bullitt

webinar-time   60 Min

Product Id: 704054

This webcast will provide an overview of U.S. Export Classification Control Numbers (ECCN) and making license determinations via the Commerce Control List (CCL).It will explain the “How to” classification breakdown and the considerations for commodity jurisdictions (CJs).

Recording Available

* Per Attendee $179

 

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