Validation for Medical Device Manufacturers - Master IQ, OQ, PQ

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 706706

Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover the validation essentials for medical device manufacturers. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. Validation is a powerful tool in understanding, optimizing, and controlling manufacturing processes. We’ll cover the essential steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

15 / Jun / 2021 - Tuesday

 

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.

13 / Jul / 2021 - Tuesday

* Per Attendee $199

 

Medical Device Cybersecurity Risk Management Training

webinar-speaker   Frank Stein

webinar-time   3 Hrs

Product Id: 706560

This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.

20 / Jul / 2021 - Tuesday

* Per Attendee $329

 

Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes

webinar-speaker   Betty Lane

webinar-time   75 Min

Product Id: 702502

This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.

28 / Jul / 2021 - Wednesday

* Per Attendee $199

 

Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 700817

This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.

28 / Jul / 2021 - Wednesday

* Per Attendee $229

 

Supplier Management with the new Medical Device Regulation EU MDR 745/2017

webinar-speaker   Frank Stein

webinar-time   90 Min

Product Id: 706068

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.

9 / Aug / 2021 - Monday

* Per Attendee $249

 

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

webinar-speaker   Ginette M Collazo

webinar-time   60 Min

Product Id: 704210

This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.

10 / Aug / 2021 - Tuesday

* Per Attendee $229

 

FDA's Ambitious Regulation of Social Media

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

17 / Aug / 2021 - Tuesday

* Per Attendee $229

 

How to write SOP's that Avoid Human Error

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704418

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

5 / Oct / 2021 - Tuesday

* Per Attendee $199

 

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

 

EU MDR 2017/745 Medical Devices General Safety and Performance Requirements

webinar-speaker   Juan M Campos

webinar-time   60 Min

Product Id: 706703

In this webinar, you will how to manage General Safety and Performance Requirements (GSPRs) according to EU MDR 2017/745 Annex I for full compliance with new EU Medical Device Regulation mandatory starting 26-May-2021

Recording Available

* Per Attendee $299

 

US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 705794

Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations. The FDA’s four key areas of compliance under QSIT.

Recording Available

* Per Attendee $299

 

Medical Device: Ethical Product Development

webinar-speaker   Liya Abraha

webinar-time   60 Min

Product Id: 706704

Innovation requires risk while a medical device should primarily be safe. This webinar will discuss how to navigate those two worlds and the ethical issues faced through out the product development cycle. Innovators and disruptors in this field come across ethical dilemmas and challenges at almost every level of their product cycle.

Recording Available

 

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

webinar-speaker   Frank Stein

webinar-time   4 Hrs

Product Id: 706565

This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.

Recording Available

* Per Attendee $499

 

Root Cause Analysis - The Heart of Corrective Action

webinar-speaker   Betty Lane

webinar-time   75 Min

Product Id: 703391

This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.

Recording Available

* Per Attendee $299

 

Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

webinar-speaker   Frank Stein

webinar-time   90 Min

Product Id: 706121

This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep your certificates and to sell your products after May 2020 to the European Union.

Recording Available

* Per Attendee $299

 

Quality by Design - Use Design Control to Improve Quality

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 706698

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the basics of design controls for medical devices.

Recording Available

* Per Attendee $299

 

Good Documentation Guideline (Chapter <1029> USP)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705130

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Recording Available

* Per Attendee $299

 

EU MDR 2017/745 Custom Made Medical Devices

webinar-speaker   Juan M Campos

webinar-time   60 Min

Product Id: 706696

In this webinar, you will learn how to manage custom-made medical devices according to EU MDR 2017/745 and fully comply with the new EU Medical Device Regulation which is mandatory starting 26-May-2021.

Recording Available

* Per Attendee $299

 

Medical Device: User Vs Designer - How to Better Recognize and Understand Unmet Needs

webinar-speaker   Liya Abraha

webinar-time   60 Min

Product Id: 706690

This webinar will cover how medical device designers and manufactures can better understand the unmet needs of their product users to maximize product usage and positive user experience.

Recording Available

* Per Attendee $299

 

 

 

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