WEBINARS

 

Medical Device Risk Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

CGMP controlled Raw Materials

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705148

This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.

16 / Nov / 2021 - Tuesday

* Per Attendee $249

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Recording Available

* Per Attendee $299

 

Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 700986

This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.

Recording Available

* Per Attendee $299

 

Introduction to Root Cause Investigation for CAPA

webinar-speaker   Vanessa Lopez

webinar-time   60 Min

Product Id: 704409

This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.

Recording Available

* Per Attendee $299

 

Hazard Analysis and Risk Management under ISO 14971:2007/2012

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701693

In this webinar attendees will learn how to develop, use and document Hazard Analysis and the Product Risk Management File and Report per ISO 14971:2007/12 and ICH Q9. Also a field-tested (US FDA and EU Notified Body) multi-industry “model” will be presented in detail.

Recording Available

* Per Attendee $299

 

Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

webinar-speaker   Tanvir Mahmud

webinar-time   90 Min

Product Id: 702422

This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.

Recording Available

* Per Attendee $299

 

The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 705111

This webinar will focus on the IEC standard and its key requirements: “IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices”. It will touch on “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Another webinar will focus on Part 2, and re-evaluate key portions of Part-1.

Recording Available

* Per Attendee $299

 

Risk Analysis in Medical Device Design

webinar-speaker   Charles H Paul

webinar-time   60 Min

Product Id: 704803

This webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective risk and hazard analysis for medical devices as per FDA, FTA, FMEA, and FMECA guidelines.

Recording Available

 

The Most Serious FDA 483s - How to Avoid Them

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 702766

This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

Recording Available

* Per Attendee $299

 

Failure Modes and Effects Analysis - An effective Risk Management Tool

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 701138

This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

Recording Available

* Per Attendee $299

 

Human Factors Engineering in New Product Development

webinar-speaker   Tom Kramer

webinar-time   120 Min

Product Id: 705153

This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant.

Recording Available

* Per Attendee $249

 

Process Verification and Validation Planning and Execution

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701662

This 60-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

Recording Available

* Per Attendee $249

 

How to Prepare for the New EU Medical Device Regulations

webinar-speaker   Richard Young

webinar-time   90 Min

Product Id: 705513

The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.

Recording Available

* Per Attendee $279

 

Post-market Surveillance - Clinical Evaluation and Risk Management

webinar-speaker   Daniel O Leary

webinar-time   90 Min

Product Id: 705402

This Post-market Surveillance (PMS) webinar will discuss in detail the clinical evaluation and risk management requirements as described in MedDev 2.7/1 Rev. 4, EN ISO 14971:2012 and EN ISO 14971:2012 standards and how they are related. It will also explain some of the recent changes in EU medical device regulations.

Recording Available

* Per Attendee $249

 

Medical Device Software Verification and Validation

webinar-speaker   Nancy Knettell

webinar-time   60 Min

Product Id: 705393

This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.

Recording Available

* Per Attendee $249

 

Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity

webinar-speaker   Edwin Waldbusser

webinar-time   60 Min

Product Id: 705432

This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.

Recording Available

 

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

 

Whistle While You Work: Protecting Your Organization from Whistleblower Threats

webinar-speaker   Christine Zack

webinar-time   60 Min

Product Id: 705413

This webinar will provide an overview of SEC Whistleblower Rules such as False Claims Act, Dodd-Frank, Sarbanes-Oxley and Commodity Exchange Act. It will also discuss best practices on how to mitigate damages from an actual or purported whistleblower.

Recording Available

 

Project Risk Management

webinar-speaker   Mario Mosse

webinar-time   90 Min

Product Id: 705015

Project risk management includes the processes of conducting risk management planning, identification, analysis, action planning, and controlling risk on a project. This training program will analyze the objectives of project risk management - to increase the likelihood and impact of positive outcomes while decreasing the likelihood and impact of negative events affecting the success of the project.

Recording Available

* Per Attendee $229

 

Life Cycle Risk Management for 21 CFR 820 and ISO 13485

webinar-speaker   Russell Pizzuto

webinar-time   90 Min

Product Id: 704964

This webinar will present a Lifecycle Risk Management System that meets FDA and ISO requirements. That risk management system (based on ISO 14971) creates a closed loop system that identifies risks, and uses field use feedback to adjust risks and to improve designs and processes. The objective evidence produced by a Lifecycle Risk Management Systems can be used to demonstrate risk management compliance to 21 CFR Part 820 and ISO 13485.

Recording Available

 

 

 

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