
Statistical Methods for Quality Improvement
Steven Wachs
90 Min
Product Id: 705856
This webinar presents an overview of essential quantitative methods for assessing and ensuring product quality. The methods include: Statistical Process Control, Process Capability Assessment, Regression Modeling, Design of Experiments, Hypothesis Testing, and Measurement Systems Assessment.

Medical Device Cybersecurity Risk Management Training
Frank Stein
3 Hrs
Product Id: 706560
This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
David Nettleton
75 Min
Product Id: 701582
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

EPCRA TRI Form "R" Reporting
Joe Keenan
90 Min
Product Id: 705126
This training program will help attendees understand the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxic Release Inventory (TRI) Form R reporting requirements. It will also elucidate what the EPCRA TRI Form R is, when they are required to be filled out, and how to properly fill them out. Further, attendees will also learn how to calculate chemical mixtures as it applies to the TRI Form R reports.

Complying with the Fair Debt Collection Practices Act
Miles Hutchinson
90 Min
Product Id: 706804
What are the rules regarding how you may contact a debtor? They are so complex and confusing! There are many issues involved, such as what questions you may and may not ask someone other than the debtor and restrictions on what you can leave in voicemail or send in an email, and the best ways to handle suspected deadbeats. What is the best practice for postings to open accounts when the debtor may file bankruptcy? Did you know that medical collections must be treated with more care than consumer collections? Learn the answers to all of these issues and your own questions when you attend this detailed presentation of the FDCPA.

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring
Steven Wachs
90 Min
Product Id: 704315
This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

The Essentials of Managing Operational Risk
Stanley Epstein
90 Min
Product Id: 702359
This course provides a systematic approach covering the fundamental steps needed to manage operational risks in banks and financial institutions. Based on the three-core approach to operational risk management, it expands into critical issues such as risk analysis, risk appetite, probability, impact, and risk mitigation processes. Because external events are an Operational Risk factor we take a brief look at the COVID-19 pandemic.

GDPR: How to protect your organization
Justin Muscolino
60 Min
Product Id: 706919
Data protection and privacy is an important issue this day and age for the public. People want to make sure they are protected. With the rules & regulations for organizations becoming stricter as we move forward, this will help confidence with the public. GDPR will provide people with more control over their privacy and personal data. It’s essential to understand the various aspects and conditions, as well as the implications of wrongdoing for organizations. This webinar will focus on the core basics and then we will have a thorough discussion on protecting your institution.

Legal & Ethical Challenges for Employers: An Increase In Burnout, Stress, & Mental Illness
Dr. Susan Strauss
90 Min
Product Id: 706946
Employers are seeing more mental health issues in their workforce than ever before. Long COVID has enhanced mental health concerns even more. Each year 1 in 5 adults is stricken with a mental illness (National Institute of Mental health), making mental illness an everyday reality for many of your employees. Yet only 1 in 3 people seek help with their illness. The ADA, HIPPA, FMLA and most states’ human/civil rights department dictate how employers deal with employees with mental health problems and could charge employers with civil rights liability. Privacy laws create challenges for employers to determine how serious a situation is and whether an employee poses a danger (though those with a mental illness pose no more risk of violence than those without a mental illness). Two thirds of employees would take a pay cut for a job that supports mental health – do you? As a manager, what can you do to better recognize and take care of your employees’ mental health? Seventy percent of employees could do more to support their employees’ mental health according to the Society of Human Rights Management (SHRM, February 15, 2023).

Human Error and Documentation Practices in Good Laboratory Practices (GLP): Understanding the Criticality of Accurate and Complete Documentation in GLP
Charles H Paul
90 Min
Product Id: 706941
In today's rapidly evolving scientific landscape, the 90-minute webinar titled "Human Error and Documentation Practices in Good Laboratory Practices (GLP)" offers an essential exploration of the critical role that accurate and complete documentation plays in maintaining the integrity of research processes. Delving into the heart of Good Laboratory Practices (GLP), this enlightening session uncovers the intricate relationship between meticulous documentation and the reliability of scientific findings. Over the course of the webinar, attendees will gain a comprehensive understanding of the multifaceted challenges posed by human errors within laboratory environments. With real-world examples, the webinar illustrates the potential consequences of inadequate documentation, underscoring the significance of precise record-keeping in safeguarding data integrity, research reproducibility, and regulatory compliance. Attendees will also glean valuable insights into common documentation errors and pitfalls, as well as invaluable strategies for bolstering documentation practices. From proactive measures and standardized procedures to fostering a culture of clarity and collaboration, participants will leave equipped with the tools to elevate their documentation practices and contribute to the overall credibility of their scientific endeavors.

UK RoHS and REACH: Post Brexit Obligations and Changes in 2024
Kelly Eisenhardt
60 Min
Product Id: 706679
This 1-hour webinar will provide high-level overview of the UK RoHS and REACH obligations effective January 1, 2024 due to Brexit. Key developments and dates will be discussed with an emphasis on the new regulations and systems implemented by the UK.

Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Carolyn Troiano
90 Min
Product Id: 706938
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle. Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.
The 6 Most Common Problems in FDA Software Validation and Verification
David Nettleton
120 Min
Product Id: 705582
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration
Jose Mora
90 Min
Product Id: 706942
Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration. Does your DHF remediation process resemble the very mess that it is trying to resolve?
The Design History File (DHF) is the objective evidence that a medical device was designed per design control guidance and applicable regulations and standards. While it is retrospective in nature, it is the end result of a process that begins with planning and ends with Design Transfer and has the Device Master Record (DMR) as a deliverable.

How to Prepare an Effective Audit Manual for an Internal Audit Department
Marna Steuart
75 Min
Product Id: 703684
This webinar will instruct attendees on how to develop an internal audit manual and offer start to finish instructions and templates on how to perform different types of audits given the project description. Audit fieldwork, audit reporting and follow-up, work-paper filing, and project closure are some of the other areas the webinar will cover.

Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences
Charles H Paul
90 Min
Product Id: 706939
The 80 problem solving process developed by the Department of Defense and driven by Ford Motor Company is a worldwide method used to improve quality address customer complaints and issues quickly and efficiently. The process helps develop rapid response to customer issues and complaints and strengthens business relationship with those customers and regulatory bodies. The process helps improve quality and supports and promotes prevention rather than simply the detection of problems.

1099 & W-9 Update - Complying with IRS Information Reporting Guidelines
Miles Hutchinson
90 Min
Product Id: 703220
For years the IRS has struggled with the independent contractor and tax collection. In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding the information reporting on taxpayers by payors – the 1099. This time-consuming reporting obligation can be streamlined in a number of ways. Join us to learn more…

Storm Water Pollution Prevention Plans (SWPPP)
Joe Keenan
90 Min
Product Id: 705510
This webinar will discuss the basics of what is required in a Storm Water Pollution Prevention Plan (SWPPP), how to develop and implement and formalized SWPPP and address site-specific questions and scenarios.

Risk Management for Medical Devices per ISO 14971 2019
Jose Mora
60 Min
Product Id: 706924
ISO 14971:2019 has introduced significant changes including benefit, reasonably foreseeable misuse and state of the art, as well as the management of risks associated with medical devices. It is important to be aware of these changes as technology continues to emerge.

How to Comply with FDA Regulations for Tobacco-Related Products: Computer System Validation, 21 CFR Part 11, & Data Integrity
Carolyn Troiano
90 Min
Product Id: 706937
This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.