Webinars

Medical Device: Risk Assessment and Mitigation through FMEA

Medical Device: Risk Assessment and Mitigation through FMEA

This 90-minute presentation will discuss a structured way to mitigate risks with minimum cost. You will learn how to use FMEA to effectively estimate and assess risks in your medical device.
Batch Record Review and Product Release

Batch Record Review and Product Release

In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and you will learn how to react to discrepancies found in these records.
Writing Effective IQ, OQ,PQ Protocols for Equipment Qualification

Writing Effective IQ, OQ,PQ Protocols for Equipment Qualification

This equipment qualification webinar will discuss the requirements for IQ, OQ, and PQ protocols. It will train about the various components of each protocol, Proper language for documenting qualification testing including how to Collect data, conduct tests, and obtaining all necessary documents.
Medical Device Industry Trends for Computer Systems Regulated by FDA

Medical Device Industry Trends for Computer Systems Regulated by FDA

FDA requires that all computer systems used to produce, manage and report data for “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
CMS Two Midnight Rule

CMS Two Midnight Rule

Attend this webinar to learn the CMS new regulation "the two midnight rule" and what are the medical and financial outcomes of the rule and how to apply the rule correctly to remain CMS compliant and the Controversial of the rule.
Medical Device Recalls - a Prevention Strategy

Medical Device Recalls - a Prevention Strategy

The rough breakdown of medical device failures is 60% residing with the product specification and only 30% of the errors in the components themselves. This rough breakdown indicates that most of the problems are referred to as management errors – caused by faulty systems, processes, and conditions. A failure of procedures and execution. In other words, management failure. In this webinar, learn the strategies to prevent such medical device recalls.
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
10 Tips for Successful Hospital Utilization Management:  From Foundation to New Trends

10 Tips for Successful Hospital Utilization Management: From Foundation to New Trends

Attend this webinar to understand hospital utilization management despite demanding payers doing everything they can to deny payment through denial of medical necessity. Learn about the best model of case management, denial management, and best practices in clinical reviews.
Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.
How to Investigate Environmental Monitoring Excursions

How to Investigate Environmental Monitoring Excursions

This OOS investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.
ANDA Submission and GDUFA Guidance

ANDA Submission and GDUFA Guidance

In order to properly, effectively, and efficiently bring generic drugs and medicinal products to market, it is crucial to anyone interacting with the submittal process to understand how the process is structured and functions
FDA Inspections: Anticipation, Preparation, Reaction, Conclusion…Repeat

FDA Inspections: Anticipation, Preparation, Reaction, Conclusion…Repeat

FDA regulated industries can prophet by understanding the regulatory power of FDA and incorporating this knowledge into their daily routine. Time and resources spent preparing for the inevitable inspection will pay back proportionately. By doing your homework and putting simple principles to work you can minimize the negative effects of FDA’s power and put everyone in your organization at ease. By understanding the risks inherent in your products, you can develop a quality system that will align your operation with FDA’s expectations. Why live in fear when you can rest at night knowing you are ready?
How to Ensure Your Foreign Vendors are FDA Compliant: Conducting Vendor Audits, Monitoring, and Using Checklists

How to Ensure Your Foreign Vendors are FDA Compliant: Conducting Vendor Audits, Monitoring, and Using Checklists

This webinar will give information on auditing foreign vendors for FDA compliance. It will discuss initiating audits, planning and preparing vendor audits, as well as, monitoring foreign vendor compliance. This webinar will provide FDA guidance on foreign vendor expectations, what to do and what not to upon selecting a foreign vendor. It will also provide audit formats and checklists for ensuring a foreign vendor is qualified.
Streamlining your QMS and Audit System for Remote Audits

Streamlining your QMS and Audit System for Remote Audits

This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.
Care Coordination: A Fundamental Role for Managing Cost and Length of Stay

Care Coordination: A Fundamental Role for Managing Cost and Length of Stay

In this care coordination training you will learn how to apply the key strategies for reducing your hospital’s cost and length of stay. Also you will learn how to appreciate the role of interdisciplinary care rounds by identifying your hospital’s strength and weakness related to care coordination.
FDA Is Here, Now What?

FDA Is Here, Now What?

Attend this webinar how to handle the FDA if they show up at your door or in your email. FDA conducts regular inspections on a daily basis. Learn what rights you do and do not have when they show up for an inspection. Also, learn how to be prepared and what to do when they show up.
FDA Inspections: Understanding the Core Elements – Part I

FDA Inspections: Understanding the Core Elements – Part I

Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
How to Prepare a Standard Operating Procedure (SOP)?

How to Prepare a Standard Operating Procedure (SOP)?

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
Implementing a Quality Management System

Implementing a Quality Management System

This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.

You Recently Viewed