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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.