WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706930

We will discuss the importance of complying with FDA requirements for validation of systems using technologies that have been emerging for the past couple of decades. While FDA is planning to overhaul their own infrastructure to gain efficiencies, they are also encouraging industry to take advantage of newer technology and systems. These include cloud-based systems, Software-as-a-Service (SaaS), artificial intelligence, and others.

We’ll talk about taking a risk-based approach to validation, and how to implement newer capabilities such as electronic records and electronic signatures. We’ll also cover the importance of meeting data integrity compliance.

18 / Mar / 2024 - Monday

* Per Attendee $199

 

Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

webinar-speaker   Frank Stein

webinar-time   90 Min

Product Id: 706165

Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. This need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

18 / Mar / 2024 - Monday

* Per Attendee $199

 

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.

21 / Mar / 2024 - Thursday

* Per Attendee $199

 

Lean Manufacturing For U.S. FDA-Regulated Industries

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706960

New and Realistic Lean Manufacturing can be a key to company success, by incorporating basic lean principles, while addressing FDA / CGMP requirements.

27 / Mar / 2024 - Wednesday

* Per Attendee $199

 

The Unthinkable: Violence in Healthcare from Bullying to an Active Shooter

webinar-speaker   Dr. Susan Strauss

webinar-time   120 Min

Product Id: 704727

The healthcare environment creates a major challenge in the prevention and intervention of violence. The rate of injuries and illness from violence in the healthcare industry is more than three times greater than violence in all private industry. This training program will explore what makes violence in healthcare unique and its negative ramifications on quality patient care.

28 / Mar / 2024 - Thursday

* Per Attendee $229

 

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

webinar-speaker   Kelly Eisenhardt

webinar-time   60 Min

Product Id: 703871

This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.

29 / Mar / 2024 - Friday

* Per Attendee $199

 

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).

3 / Apr / 2024 - Wednesday

* Per Attendee $199

 

The 6 Most Common Problems in FDA Software Validation and Verification

webinar-speaker   David Nettleton

webinar-time   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.

3 / Apr / 2024 - Wednesday

* Per Attendee $249

 

NEW Nacha Rule – Third-Party Sender (TPS) Roles and Responsibilities

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 706803

This session will help the attendee to identify a Third-Party Sender (TPS) and a “nested” TPS. In addition, we will cover the details needed in the agreements between all parties and what parties based on their role. Discussion on the registration requirement for both the TPS and the nested TPS and what that means to the ODFI.

3 / Apr / 2024 - Wednesday

* Per Attendee $199

 

Mastering OSHA's 2024 Recordkeeping Changes and Beyond

webinar-speaker   Joe Keenan

webinar-time   60 Min

Product Id: 706964

The audience will take away a basic understanding of what the OSHA Recordkeeping Requirements are and learn to navigate the complexities in filling out the 2024 OSHA Recordkeeping Forms.

9 / Apr / 2024 - Tuesday

* Per Attendee $199

 

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703590

This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.

9 / Apr / 2024 - Tuesday

* Per Attendee $199

 

10 Keys for Maximizing the Benefits of your SPC Program

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 706957

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to “listen” to their processes so that potentially harmful changes will be quickly detected and rectified.

However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility. Highly effective SPC programs combine technical competencies, such as using an appropriate chart and sample size for the application, with effective management techniques such as enabling operator buy-in and involvement. This webinar identifies and describes ten keys that unleash the power of SPC.

11 / Apr / 2024 - Thursday

* 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.

16 / Apr / 2024 - Tuesday

* Per Attendee $199

 

Current Trends in CDER/CBER FDA Inspections

webinar-speaker   Michael Ferrante

webinar-time   90 min

Product Id: 706965

This webinar will focus on the current trends in FDA Inspections and guidelines and how this information can be utilized to provide a foundation for compliance with the latest quality and regulatory requirements. Attendees will learn how to proactively prepare for an inspection.

17 / Apr / 2024 - Wednesday

* Per Attendee $199

 

Deconstructing EU MDR with Principles of Lean Documents and Lean Configuration

webinar-speaker   Jose Mora

webinar-time   120 Min

Product Id: 706959

The EU MDR is a comprehensive and complex regulation that combines all aspects of placing certain types of medical devices on the EU market into one regulation. It addresses the obligations of economic operators in this role, and provides for extensive databases, clinical requirements, classifications, conformity, and many defined relationships between agencies, member states, and other directives and regulations.

This webinar deconstructs the many parts of this regulation into the elements of lean documents and lean configuration, providing an opportunity to apply these principles as a way to create and maintain flexibility as this and new harmonized standards and regulations emerge.

17 / Apr / 2024 - Wednesday

* Per Attendee $229

 

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

webinar-speaker   Steven Wachs

webinar-time   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.

Recording Available

 

Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences

webinar-speaker   Charles H Paul

webinar-time   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.

Recording Available

 

GDPR: How to protect your organization

webinar-speaker   Justin Muscolino

webinar-time   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.

Recording Available

 

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

 

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