WEBINARS

 

Compliance Training Webinars for Regulated Industries

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The 510(k) Mod Program, Breakthrough Technologies, and STeP

webinar-speaker   John E Lincoln

webinar-time   90 min

Product Id: 706976

What are the U.S. FDA's recently expanded, less traditional / modified pathways for novel technologies or safer products to receive clearand or approval.

7 / Aug / 2024 - Wednesday

* Per Attendee $199

 

The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?

webinar-speaker   Dr. Susan Strauss

webinar-time   90 Min

Product Id: 704959

The webinar training will address ADAAA, FMLA, and Worker’s Comp laws that HR is responsible for upholding. When the laws are not followed, it increases the liability for the organization and interferes with a fair and equitable work environment for employees.

Recording Available

* Per Attendee $249

 

The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706961

The US FDA, after years of discussing the harmonization of 21 CFR 820, Device CGMPs (QSR), to the ISO 13485, Device QMS, has finally published their QMSR to replace the previous QSR. On February 02, 2024, they published the final rule in the US Federal Register that revises 21 CFR 820 to include ISO 13485:2016 by reference, called the Quality Management System Regulation (QMSR).

Recording Available

* Per Attendee $249

 

Operational Risk Management Principles

webinar-speaker   Stanley Epstein

webinar-time   90 Min

Product Id: 706024

This webinar provides participants with practical guidance in implementing an effective operational risk management system. It will also bring you up to speed on current best practice in the field of managing operational risk in financial institutions. Not only will we examine the details of each of these principles, as well as taking an all-inclusive look and what needs to happen to implement them; we will complete our journey by examining the principles under the harsh light of an actual Case Study in the banking industry.

Recording Available

* Per Attendee $249

 

Process for Performing a Vendor/Contract Audit: What Should be Considered and How to Plan, Perform and Report Results of a Vendor Audit

webinar-speaker   Marna Steuart

webinar-time   75 Min

Product Id: 706219

Attend this webinar to learn about the different contract terms, different ways to determine the scope of the audit given contract terms and conditions, how to plan, perform and report results of a vendor audit.

Recording Available

* Per Attendee $249

 

Latest Changes to RoHS and REACH for 2024

webinar-speaker   Kelly Eisenhardt

webinar-time   60 Min

Product Id: 706070

This 1-hour webinar will go into the specifics of the REACH and RoHS regulations and review the latest amendments and changes to both regulations for 2024. We will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms.

Recording Available

* Per Attendee $249

 

Drug Labeling and Packaging: Meeting Regulatory Requirements

webinar-speaker   Charles H Paul

webinar-time   60 Min

Product Id: 706953

The webinar, titled "Drug Labeling and Packaging: Meeting Regulatory Requirements," is a comprehensive exploration of the critical nexus between pharmaceutical labeling, packaging, and regulatory mandates. Over the course of 60 minutes, this session will provide participants with a thorough understanding of the pivotal role that accurate and compliant drug labeling and packaging play in ensuring patient safety and meeting global regulatory standards.

Recording Available

* Per Attendee $249

 

FDA's New Software Validation Requirements

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706952

CGMP companies must develop / implement formal software V&V for medical product under IEC 62304 and a key US FDA Guidance Document.

Recording Available

* Per Attendee $249

 

Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability & Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706951

The California Consumer Privacy Act (CCPA) was enacted into law on June 28, 2018 and became effective on January 1, 2020. CCPA provided a variety of consumer privacy rights and the obligations of business related to their storage and sale of personal information.

Voters in California voted to approve Proposition 24, a ballot measure, on November 3, 2020, which created the California Privacy Rights Act (CPRA). The purpose of CPRA was to modify and expand the requirements of the CCPA, thus amending the original act. CPRA is commonly referred to as “CCPA 2.0.”

CPRA ends the ban on providing the CCPA’s consumer privacy rights to a company’s employees. Under CPRA, all employers must respond to requests from employees to access or correct their personal data. Enforcement of CPRA will become effective in July 2023, enabling companies six months to ramp up their efforts to comply with it.

CPRA also extends new protections to consumers residing in California. Those organizations doing business with these consumers are subject, based on defined threshold of operation, to the compliance requirements.

Recording Available

* Per Attendee $249

 

How to Achieve Validation Requirements for a Clean Room Manufacturing Environment

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706947

Both the U.S. FDA and EU's MDR expect documented risk-based clean room manufacturing environment per ISO 14644-series, ISO 14698-series (and the old FED-STD 209E).

Recording Available

* Per Attendee $249

 

Optimizing Target Weights for Foods and Beverages

webinar-speaker   Steven Wachs

webinar-time   75 Min

Product Id: 704366

This training program will elaborate factors affecting the target weight decision and help determine the tolerable risks of under-filling and the costs of over-filling. Attendees will gain an understanding of process stability and process capability concepts and methods for process optimization.

Recording Available

* Per Attendee $249

 

US FDA Medical Device QSR (21 CFR 820) / Quality Management System - current and proposed major changes

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706950

The US FDA/CDRH is proposing to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) by converging its requirements with requirements used by many other regulatory authorities. ISO 13485, into a new device Quality Management System Regulation (QMSR).

Recording Available

* Per Attendee $249

 

Cybersecurity - The Latest US FDA Requirements

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706949

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry. 

Recording Available

* Per Attendee $249

 

Validation Statistics for Non-Statisticians

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706944

In this program, we will discuss the common statistics tools and techniques used in validation. Through real world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. Discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion of the concept of process capability and using process capability to set acceptance criteria for validation.

Recording Available

* Per Attendee $249

 

Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration

webinar-speaker   Jose Mora

webinar-time   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.

Recording Available

* Per Attendee $249

 

Medical Device Cybersecurity Risk Management Training

webinar-speaker   Frank Stein

webinar-time   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.

Recording Available

* Per Attendee $399

 

Statistical Methods for Quality Improvement

webinar-speaker   Steven Wachs

webinar-time   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.

Recording Available

* Per Attendee $249

 

1099 & W-9 Update - Complying with IRS Information Reporting Guidelines

webinar-speaker   Miles Hutchinson

webinar-time   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…

Recording Available

* Per Attendee $249

 

Storm Water Pollution Prevention Plans (SWPPP)

webinar-speaker   Joe Keenan

webinar-time   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.

Recording Available

* Per Attendee $249

 

Risk Management for Medical Devices per ISO 14971 2019

webinar-speaker   Jose Mora

webinar-time   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.

Recording Available

* Per Attendee $249

 

 

 

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