Webinars

Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences

Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences

The 80 problem solving process developed by the Department of Defense and driven by Ford Motor Company is a worldwide method used to improve quality address customer complaints and issues quickly and efficiently. The process helps develop rapid response to customer issues and complaints and strengthens business relationship with those customers and regulatory bodies. The process helps improve quality and supports and promotes prevention rather than simply the detection of problems.
The 510(k) Mod Program, Breakthrough Technologies, and STeP

The 510(k) Mod Program, Breakthrough Technologies, and STeP

What are the U.S. FDA's recently expanded, less traditional / modified pathways for novel technologies or safer products to receive clearand or approval.
US FDA Requirements for Medical Products Labeling / UDI

US FDA Requirements for Medical Products Labeling / UDI

The U.S. FDA has several requirement for the labeling of medical products. The key requirements are in 21 CFR 801.
Making FMEA a More Efficient and Powerful Patient Safety Improvement Tool

Making FMEA a More Efficient and Powerful Patient Safety Improvement Tool

This FMEA (Failure mode and effects analysis) training will cover the Joint Commission requirements for conducting a proactive risk assessment using the FMEA methodology.
Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Risk Management

Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Risk Management

This Failure Modes and Effects Analysis (FMEA) Webinar will give an overview and elements of an FMEA. The analysis of data outputs will also be discussed.
The GLPs and Analytical Test Methods Validation

The GLPs and Analytical Test Methods Validation

Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al
Medical Devices Periodic Safety Update Report (PSUR)

Medical Devices Periodic Safety Update Report (PSUR)

PSURs are pharmacovigilance and device adverse events documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization in the EU. The purpose is to harmonize and strengthen benefit-risk review of medical products across the European Economic Area.
Lead Auditor EN ISO 13485:2021 and EU IVDR 2017/746 - Regulation

Lead Auditor EN ISO 13485:2021 and EU IVDR 2017/746 - Regulation

Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. These needs smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.
Commissioning and Qualification Training Course

Commissioning and Qualification Training Course

This online program offers an introduction to the international principles and regulations behind commissioning and installation qualification (IQ).
How to Globally Register a Medical Device?

How to Globally Register a Medical Device?

Attend this webinar if you are faced with the task of having to register a product worldwide and need to think about the most sensible and efficient way to do so. The correct order of the countries and the provision of the documents and what the differences are between the various technical dossiers of the countries are often decisive here.
The Summary of Safety and Clinical Performance (SSCP)

The Summary of Safety and Clinical Performance (SSCP)

Attend this webinar to understand, what are the requirements of article 32 EU MDR 2017/745 for implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance (SSCP). Your implementation needs smart ideas to reach the right level to pass the quality management audit and technical file audit by your notified body or authority inspection.
The Human Error Tool Box: A Practical Approach to Human Error

The Human Error Tool Box: A Practical Approach to Human Error

This course offers practical approaches and tools to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.
Avoidable Delay Management: How to Take Control of Your Length of Stay

Avoidable Delay Management: How to Take Control of Your Length of Stay

This webinar will help you identify factors that cause delays as patients progress through their stay and how to correct these barriers to care. Learn the most streamlined ways in which to integrate avoidable delay management into your day and with all the members of the interdisciplinary care team. Finally, it will review some examples of report cars that can be used to understand the data you have collected.
Pharmaceutical Quality Management - Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible

Pharmaceutical Quality Management - Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible

This instructor-led live webinar will discuss the established approach of Pharmaceutical Quality Management as it relates to the relationship between risk management and the pharmaceutical regulations that govern the business.
21 CFR Part 111 - Specification Requirements

21 CFR Part 111 - Specification Requirements

The 21 CFR Part 111 dietary supplement regulations require six categories of specifications before established before manufacturing product or releasing a batch into distribution. This course will review the six categories and their regulatory requirements while translating those requirements into a workable document.
Universal Hygienic Design for FSMA Compliance-Equipment

Universal Hygienic Design for FSMA Compliance-Equipment

Hygienic Design in food processing is a given, however FDA’s #483 violations continue to reflect organizations clearly lack the necessary requirements to maintain safe environments for food production. This course will outline the basics food facilities should have in place and how to ensure program meets FDA’s expectations.
Product Testimonials and Endorsements in Advertising for Dietary Supplements

Product Testimonials and Endorsements in Advertising for Dietary Supplements

Use of customer testimonials, reviews, or endorsements in the advertising of dietary supplement products can be considered “commercial speech”, depending on how and where it is used. It is the responsibility of your organization to ensure use of this content in the promotion and advertising of products is not only used with permission, but is also accurate and compliant with FDA and FTC regulations. This webinar discusses important regulatory considerations when incorporating user-generated content in the advertising of dietary supplements.
Case Management Outcomes: How to Know if you are Working in a Best Practice Framework

Case Management Outcomes: How to Know if you are Working in a Best Practice Framework

Managing case management outcomes and the creation of tools with which to study those outcomes is an important component of the work that case management professionals must engage. This data helps us better understand where we are doing well and where we might need to improve. Case management report cards are also a useful tool for reporting data to the Utilization Committee, a requirement under the CMS Conditions of Participation for Utilization Review.
Applied Time Series Analysis in Healthcare

Applied Time Series Analysis in Healthcare

This 3-hour seminar will provide attendees with the theory and application of time series analysis. The main focus will be on autoregressive integrated moving average (ARIMA) techniques. Variations of the ARIMA and other models which operate under non-linear data, non-stationary data, seasonality, and trends will also be examined.

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