WEBINARS

 

Compliance Training Webinars for Regulated Industries

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.

27 / Feb / 2024 - Tuesday

* Per Attendee $199

 

Digital Payments 2023 – the future of payments

webinar-speaker   Stanley Epstein

webinar-time   120 Min

Product Id: 704753

This webinar examines the current state of the payments industry - from the complexity of the current payments landscape, the growing range of bank and non-bank participants, the ever-increasing range of payments methods, interfaces and systems, open banking, regulation and the future payments scene. We also look at how the COVID-19 pandemic has and will continue to affect payments.

27 / Feb / 2024 - Tuesday

* Per Attendee $229

 

Protecting Ecosystems

webinar-speaker   Keith Warwick

webinar-time   60 Min

Product Id: 706955

28 / Feb / 2024 - Wednesday

* Per Attendee $199

 

Integrating Production Equipment, Processes, Systems and Procedures

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706956

Both the U.S. FDA and EU's MDR expect documented risk-based equipment, process,systems and procedures development, integration and maintenance.

5 / Mar / 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.

6 / Mar / 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.

7 / Mar / 2024 - Thursday

* Per Attendee $199

 

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

webinar-speaker   David Nettleton

webinar-time   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.

12 / Mar / 2024 - Tuesday

* Per Attendee $229

 

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.

12 / Mar / 2024 - Tuesday

* Per Attendee $199

 

Medical Products Manufacturing Operations, Regulations and Controls

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706958

This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.

15 / Mar / 2024 - Friday

* Per Attendee $199

 

Report Writing for Auditing Professionals

webinar-speaker   Phil Vassallo

webinar-time   90 Min

Product Id: 703814

Skilled auditors require a method that aligns what they experienced during the reviewing process with what they compose during the writing process. This report writing workshop will provide foundation resources that participants can continually turn to during intense, complex audit engagements.

15 / Mar / 2024 - Friday

* Per Attendee $199

 

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

 

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.

20 / Mar / 2024 - Wednesday

* Per Attendee $229

 

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

 

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

 

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

 

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