Webinars

Understanding, Calculating, and Using Statistical Power in Sample Size Determinations for Significance Tests

Understanding, Calculating, and Using Statistical Power in Sample Size Determinations for Significance Tests

Calculation of power is so complicated that it typically must be done with a software program. Even so, the software program's output can be misunderstood unless the user has a firm understanding of the basic concept of statistical power. This seminar helps the attendee to understand and use the output of power calculations, to determine adequate sample sizes and to determine whether or not a product or process meets requirements.
Human Error Reduction Techniques for Floor Supervisors

Human Error Reduction Techniques for Floor Supervisors

Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
ISO 13485:2016 - What are the hot topics and changes?

ISO 13485:2016 - What are the hot topics and changes?

In this quality management system webinar attendees will learn the recent changes to ISO 13485:2016 standard in step by step process and how to implement these changes in their current quality management system to pass the quality management audit. Also attendees will gain knowledge on how to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems.
The Utilization Management Committee: Strategies for coordinating Medical Practice with Hospital Goals

The Utilization Management Committee: Strategies for coordinating Medical Practice with Hospital Goals

This webinar will provide a detailed overview of proven strategies that maybe employed to ensure that hospital goals are aligned with medical practice. This is key to delivering high-quality coordinated care to produce Quality Patient Outcomes and Cost-Effectiveness. There will be special focus on the Utilization Review Committee (URC) as a CoP.
Global Food Additive Regulation Review: Headwinds and Opportunities

Global Food Additive Regulation Review: Headwinds and Opportunities

This webinar will start with a general background about global regulations and then go into detail about specific food additives and how the regulations vary in specific international, regional regulatory and country regulatory documents.
Food Safety Modernization Act (FSMA) - DEEP DIVE

Food Safety Modernization Act (FSMA) - DEEP DIVE

This webinar will give you a deeper dive understanding of some of the FDA’s FSMA (Food Safety Modernization Act) rules and a deeper dive understanding into the FSVP (Foreign Supplier Verification Program) rule including common mistakes made.
Preparing for and Responding Effectively In a Positive Manner to an FDA Postmarket Surveillance Visit

Preparing for and Responding Effectively In a Positive Manner to an FDA Postmarket Surveillance Visit

Premarket Approvals Premarket approval (PMA) are required by The Food and Drug Administration is the regulatory protocol presently used to evaluate the safety and effectiveness of Class III medical devices, e.g., an implantable cardioverter defibrillator (ICD). This webinar will help you understand the nature, severity, or frequency of suspected problems reported in adverse event reports or in the published literature. The information when applied is most effective in reducing potential adverse events.
Medical Device Registration Requirements in Saudi Arabia and MEA

Medical Device Registration Requirements in Saudi Arabia and MEA

This webinar will discuss the basics of product registration in Saudi Arabia and MEA such as Registration Timelines, documentation requirements and governmental processes.
Good Documentation Practice (GDocP) for FDA Regulated Industry

Good Documentation Practice (GDocP) for FDA Regulated Industry

This good documentation practice webinar will discuss connection between CxP/GMP and document control, which documents need to be controlled and which are not, what documentation required for QMS, how QA can plays an important role in documentation systems. It will also discuss how change control procedure should be used in GxP/GMP environment.
Data Blocking and Patient Access of Medical Records under HIPAA - New Focus of Enforcement and Guidance

Data Blocking and Patient Access of Medical Records under HIPAA - New Focus of Enforcement and Guidance

This training program will provide a comprehensive look at the changes in the new access rights under HIPAA and CLIA regulations and prepare attendees for the process of incorporating the changes into how they do business in their facilities. It will also explain how the HIPAA audit and enforcement activities are now being increased and what needs to be done to survive a HIPAA audit.
Navigating California's Prop 65 for the Food Industry

Navigating California's Prop 65 for the Food Industry

This Prop 65 webinar will examine the current climate regarding Prop 65, some of the media buzz and pending actions. Also mitigation strategies will be examined as applied under new FSMA (Food Safety Modernization Act), utilizing preventative programs to minimize potential hazardous risks.
HIPAA Audits and Enforcement for 2020 and Beyond - Current Issues and Focus for HIPAA Compliance in the Coming Year

HIPAA Audits and Enforcement for 2020 and Beyond - Current Issues and Focus for HIPAA Compliance in the Coming Year

This webinar will discuss HIPAA audit and enforcement regulations and processes for 2020 and how they apply to covered entities and business associates. Attendees will learn how to prepare for HIPAA audit to avoid fines and penalties for HIPAA violations.
Supplier Management with the new Medical Device Regulation EU MDR 745/2017

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

The implementation deadline of EU MDR 745/2017 is 2020. This webinar will help you learn how to quickly implement it in a simple way and pass the Quality Management Audit by your certification company or notified body. It covers the topic of supply chain and the interfaces to the EN ISO 13485:2016.
Supplier and Service Provider Controls: FDA Expectations

Supplier and Service Provider Controls: FDA Expectations

This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
Statistical Elements of Real-Time qPCR

Statistical Elements of Real-Time qPCR

Join Elaine Eisenbeisz as she shows you how to use data to estimate a standard curve, how to perform computations for absolute and relative quantification. She will also present a few decision-making criteria and statistical tests that can be used with qPCR data.
Introduction to Root Cause Investigation for CAPA

Introduction to Root Cause Investigation for CAPA

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.
How to Prepare for an FDA Inspections?

How to Prepare for an FDA Inspections?

In this FDA inspection webinar attendees will learn the regulatory requirements for all FDA-regulated products. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those following complaints or recalls. It will also highlight why the prudent firms needs to prepare them self for such inspections.
FDA's Ambitious Regulation of Social Media

FDA's Ambitious Regulation of Social Media

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.
Product Stability Testing Program - Designing and Sustaining New and Existing Programs

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
Overcoming Obstacles of The Canadian Drug Regulatory Landscape

Overcoming Obstacles of The Canadian Drug Regulatory Landscape

The Canadian Drug Approval Process is misunderstood by many and considered harsh by some. We will explore reasons why the Canadian market should not be overlooked and the benefits of including Canada in strategic drug development initiatives. We will share insights and practical examples that facilitate a positive, proactive and transparent interaction with Health Canada, and provide strategies for avoiding obstacles and managing them efficiently should they occur.

You Recently Viewed