ComplianceOnline
Validation for Medical Device Manufacturers - Master IQ, OQ, PQ
15
/ Jun
Tuesday-2021

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

  • Speaker: Susanne Manz
  • Product ID: 706706
  • Duration: 90 Min
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.
* Per Attendee
$199
How to Prepare a Standard Operating Procedure (SOP)?
15
/ Jun
Tuesday-2021

How to Prepare a Standard Operating Procedure (SOP)?

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
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.
* Per Attendee
$199
Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention
13
/ Jul
Tuesday-2021

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

  • Speaker: Jeff Kasoff
  • Product ID: 700986
  • Duration: 60 Min
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! In this webinar, learn the best practices for managing complaints.
* Per Attendee
$199
Recorded/CD
EU MDR 2017/745 Medical Devices General Safety and Performance Requirements

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

  • Speaker: Juan M Campos
  • Product ID: 706703
  • Duration: 60 Min
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
CD/Recorded
$299
Recorded/CD
US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

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

  • Speaker: John E Lincoln
  • Product ID: 705794
  • Duration: 60 Min
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.
CD/Recorded
$299
Recorded/CD
Medical Device: Ethical Product Development

Medical Device: Ethical Product Development

  • Speaker: Liya Abraha
  • Product ID: 706704
  • Duration: 60 Min
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.
Recorded/CD
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

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

  • Speaker: Frank Stein
  • Product ID: 706565
  • Duration: 4 Hrs
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.
CD/Recorded
$499
Recorded/CD
How to write SOP's that Avoid Human Error

How to write SOP's that Avoid Human Error

  • Speaker: Ginette M Collazo
  • Product ID: 704418
  • Duration: 90 Min
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.
CD/Recorded
$299
Recorded/CD
Root Cause Analysis - The Heart of Corrective Action

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
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.
CD/Recorded
$299
Recorded/CD
Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

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

  • Speaker: Frank Stein
  • Product ID: 706121
  • Duration: 90 Min
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.
CD/Recorded
$299
Recorded/CD
Quality by Design - Use Design Control to Improve Quality

Quality by Design - Use Design Control to Improve Quality

  • Speaker: Susanne Manz
  • Product ID: 706698
  • Duration: 90 Min
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.
CD/Recorded
$299
Recorded/CD
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
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.
CD/Recorded
$299
Recorded/CD
EU MDR 2017/745 Custom Made Medical Devices

EU MDR 2017/745 Custom Made Medical Devices

  • Speaker: Juan M Campos
  • Product ID: 706696
  • Duration: 60 Min
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.
CD/Recorded
$299
Recorded/CD
Medical Device: User Vs Designer - How to Better Recognize and Understand Unmet Needs

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

  • Speaker: Liya Abraha
  • Product ID: 706690
  • Duration: 60 Min
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.
CD/Recorded
$299
Recorded/CD
Supplier Management with the new Medical Device Regulation EU MDR 745/2017

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

  • Speaker: Frank Stein
  • Product ID: 706068
  • Duration: 90 Min
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.
CD/Recorded
$299
Recorded/CD
CGMP controlled Raw Materials

CGMP controlled Raw Materials

  • Speaker: Charity Ogunsanya
  • Product ID: 705148
  • Duration: 90 Min
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.
CD/Recorded
$399
Recorded/CD
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

  • Speaker: John E Lincoln
  • Product ID: 701898
  • Duration: 90 Min
This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.
CD/Recorded
$249
Recorded/CD
What Is A Sterilization Dose Audit and How Are They Performed?

What Is A Sterilization Dose Audit and How Are They Performed?

  • Speaker: Martin Byrne
  • Product ID: 706688
  • Duration: 60 Min
The one-hour training discusses the major elements that should be considered prior to, during, and after the performance of a dose audit. The training is designed to instruct attendees on how to critically think about the preparation, performance, reporting, and responding to failures for a dose audit.
CD/Recorded
$299
Recorded/CD
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

  • Speaker: Charity Ogunsanya
  • Product ID: 703875
  • Duration: 90 Min
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.
CD/Recorded
$299
Recorded/CD
EU MDR 2017/745 Medical Device Classification

EU MDR 2017/745 Medical Device Classification

  • Speaker: Juan M Campos
  • Product ID: 706685
  • Duration: 60 Min
In this webinar, you will learn how to classify medical devices according to EU MDR 2017/745 Annex VIII for full compliance with new EU Medical Device Regulation mandatory starting 26-May-2021
CD/Recorded
$299
Best Sellers
You Recently Viewed
    Loading