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Webinars

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.
Human Errors in GMP Manufacturing and Laboratory Processes Identification, Correction and Prevention, Latest FDA Regulatory Requirements & Most Common GMP Issues Caused by Human Error

Human Errors in GMP Manufacturing and Laboratory Processes Identification, Correction and Prevention, Latest FDA Regulatory Requirements & Most Common GMP Issues Caused by Human Error

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.
How low can you go? Different ways to determine the limit of detection

How low can you go? Different ways to determine the limit of detection

This webinar will present and apply FBI, FDA and EPA approved methods for the determination of limits of detection (LOD) and limits of quantitation (LOQ) in chemical forensic and environmental analysis. These methods apply to most analytical techniques including gas and liquid chromatography, mass spectrometry, and elemental and molecular spectroscopy and can be used when analyzing blood, urine, food, or trace evidence for the presence of toxic chemicals or drugs.
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.
MIPS Audit Vulnerabilities and Preparations

MIPS Audit Vulnerabilities and Preparations

MIPS Data Validation Audits started in June of 2019. The MIPS has a number of vulnerabilities related to its reporting requirements and associated complexities. This presentation will address potential vulnerabilities and provide specific recommendations that will help protect your practice from a negative audit.
Reduce Compliance and Recordkeeping Burdens

Reduce Compliance and Recordkeeping Burdens

This webinar will cover strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. It will get you started in setting up a quality system that reduces compliance burden. We’ll. discuss techniques for improving efficiency, reducing burden, and still maintain an effective QMS.
Managing Non-conforming Material and Failure Investigations

Managing Non-conforming Material and Failure Investigations

Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You’ll learn how to identify, segregate, control, and disposition non-conforming material. You’ll learn about when and how to conduct failure investigations and requirements for correction and corrective action.
Regulatory and Testing Requirements of Bacterial Endotoxin Testing (BET) using LAL

Regulatory and Testing Requirements of Bacterial Endotoxin Testing (BET) using LAL

cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.
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