The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs
John E Lincoln
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).
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.
NEW Nacha Rule – Third-Party Sender (TPS) Roles and Responsibilities
Donna K Olheiser
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.
Mastering OSHA's 2024 Recordkeeping Changes and Beyond
Joe Keenan
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.
Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
Roger Cowan
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.
10 Keys for Maximizing the Benefits of your SPC Program
Steven Wachs
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.
The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?
Dr. Susan Strauss
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.
Current Trends in CDER/CBER FDA Inspections
Michael Ferrante
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.
Deconstructing EU MDR with Principles of Lean Documents and Lean Configuration
Jose Mora
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.
Family Care and Medical Leave in California - Part I
Jacquiline M Wagner
90 Min
Product Id: 704507
The Family and Medical Leave Act (29 U.S.C. § 2601 et seq)- known as the “FMLA”- was signed into law by President Bill Clinton in 1993 in response to a growing national concern about balancing work and family responsibilities.
Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3
John E Lincoln
90 Min
Product Id: 706923
Proper adherence and documentation of the FDA's Design Control requirements are key to any medical product project's success.
Supplemental Pay Essentials - Severance Pay, Deferred Compensation, Recordkeeping and Fringe Benefits
Patrick A Haggerty
90 Min
Product Id: 704112
This training program will help attendees distinguish between supplemental wage payments and regular wage payments and help them identify wage payments that are neither supplemental nor regular. It will also detail methods used to compute withholding on supplemental pay including examples.
Power BI - Data Cleaning and Transformation: From Raw and Poor to Report-Ready
Mike Thomas
60 Min
Product Id: 706962
This training is aimed at existing users of Microsoft Power BI who have mastered the basics and want to take their knowledge and learning to the next stage.
Digital Payments 2024 – the future of payments
Stanley Epstein
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.
P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3
John E Lincoln
90 Min
Product Id: 706963
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.
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.
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.
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.
Operational Risk Management Principles
Stanley Epstein
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.
Process for Performing a Vendor/Contract Audit: What Should be Considered and How to Plan, Perform and Report Results of a Vendor Audit
Marna Steuart
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.