Webinars

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.

Design Control for Medical Devices Including Verification/Validation

Design Control for Medical Devices Including Verification/Validation

This webinar provides an overview of design control for medical devices with an emphasis on verification and validation of design inputs. It will cover basic regulations regarding verification/validation of inputs, the trace of inputs to verification/validation, and techniques that include statistics for proper verification/validation of design inputs.
Strategies To Prevent Manufacture And Distribution Of Substandard Medications

Strategies To Prevent Manufacture And Distribution Of Substandard Medications

Substandard medications, like counterfeit drugs, present a real and increasing danger both to patients and companies. In this webinar, learn how to take a proactive approach to stay ahead of these problems.
Obtain Compliance with HCC Coding and Auditing

Obtain Compliance with HCC Coding and Auditing

HCC education to coding staff and providers can help them understand the necessary documentation specificity and improve audit results. It’s important to know the Documentation and Coding tips that will help you know when to query the provider and improve accuracy. Which provider specialties are acceptable under the CMS-HCC model to document and submit ICD-10-CM codes? Information will be shared on CMS RADV and OIG audits and compliance scrutiny so that your office/department can be proactive.
Managing GMP Complaints and Adverse Event Reports

Managing GMP Complaints and Adverse Event Reports

This webinar addresses managing GMP Complaints and Adverse Event Reports related to drug products, biologicals, and medical devices. The relevant regulations will be discussed.
Paying for Referrals: A Danger to your Freedom

Paying for Referrals: A Danger to your Freedom

The Medicare/Medicaid Fraud and Abuse Anti-Kickback Statute (the “Statute”) is alive, still with us and as viable as ever. The Statute provides that the offer or payment, as well as the solicitation or receipt, of “any remuneration” in exchange for referrals of any good, facility, service, or item for which payment may be made in whole or in part under Medicare/Medicaid is prohibited.
Cosmetic Manufacturing - How to Avoid FDA Audits

Cosmetic Manufacturing - How to Avoid FDA Audits

Although there are no official regs for cosmetic GMP’s, failure to maintain control of your operation can lead to severe regulatory consequences. You can avoid unwanted FDA oversight by maintaining cosmetic processes under control. One avoidable recall could result in a domino effect having tremendous negative impact on your organization.
Introduction to Medicare Coverage Analysis - Impact on Revenue Cycle

Introduction to Medicare Coverage Analysis - Impact on Revenue Cycle

This course will describe the Medicare Coverage Analysis (MCA) process and the revenue cycle’s uses for this document. The course will describe the creation of the MCA and the multiple uses for this document.
Use Narrow Limit Gauging to Reduce Inspection Costs

Use Narrow Limit Gauging to Reduce Inspection Costs

In this Quality Management webinar attendees will learn the traditional attribute sampling plans required for very large samples & narrow limit gauging for smaller samples that relies on tightened acceptance limits to assess the quality of a sample which can reduce the required sample size and cost of inspection.

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