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Understanding the Brazilian Regulatory Environment for Medical Devices
Claudia Thereza de Lucca Mano
60 Min
Product Id: 705721
This webinar will discuss current medical device registration requirements in Brazil and recent regulatory changes. Topics to be discussed are Company Licensing, risk assessment, how to get regulatory clearance,GMP certification, INMETRO certification, govt fees etc.
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Develop a Compliant Validation Protocol and Analytical Procedures according to the FDA Guidance and USP Good Documentation Practices
Kim Huynh-Ba
90 Min
Product Id: 705740
This Method validation protocol training will discuss the regulatory requirements of analytical test methods, the USP good documentation practices <1029> and how to establish acceptance criteria for validation.
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Understanding the new revision of USP chapter 1058: Analytical Instrument Qualification
Dr. Ludwig Huber
75 Min
Product Id: 705723
This webinar will discuss the new content of revised USP chapter 1058, will compare with the old version and discuss how to implement it. The approaches for risk based qualification, instrument lifecycle, quality agreements, how to integrate software validation and equipment qualification, how to integrate with GAMP Guide on Laboratory Computerized Systems.
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Excel for Bankers: Functions and Formulas for Financial Data Analyzation
Tom Fragale
90 Min
Product Id: 705742
Excel has many built-in functions that help you deal with that data. Attend this webinar to learn how to turn the data into meaningful information and then provide the answers that you need for yourself, your boss, your company or your organization. Learn how to use performance reports, scenarios, use of Excel in multi-user environments, relative and absolute formulas and many more.
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US Expatriate Compensation Planning and Reporting Methodology
Matthew W Burr
60 Min
Product Id: 705362
This webinar will offer attendees an understanding of compensation and planning for U.S. expatriates. It will assist you in preparing compensation plans, the reporting process, and in reporting expectations. The training session will also discuss variations across countries and common concerns/mistakes.
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Developing Effective Workers Compensation Case Management Strategies
Joe Keenan
90 Min
Product Id: 705315
Workplace injuries and illnesses can cause huge financial tolls and disrupt the workforce in an organization. This webinar will dive into the importance of developing an effective Return to Work program and presenting the program to senior management.
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System Suitability Testing (SST) for USP and FDA Compliance
Dr. Ludwig Huber
75 Min
Product Id: 702512
Amid several other critical discussions, this training program will detail FDA and international requirements for system suitability testing; SST in comparison with equipment qualification and quality control sample analysis; critical parameters for SST in EP and USP; recommendations for implementing the updated <621>; and developing an SOP for system testing.
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BSA/AML Recent Developments and Compliance
Jim George
90 Min
Product Id: 703457
This AML compliance webinar will discuss recent developments in Bank Secrecy Act including various forms such as Currency Transaction Report (CTR), money log and Suspicious Activity Report (SAR).Attendees will learn best practices to ensure compliance with BSA regulations and avoid violations and fines.
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How ISO/IEC 27001 Can help Achieve GDPR Compliance and Reduce Data Breach Risks
Robert Davis
60 Min
Product Id: 705746
This GDPR webinar will discuss the benefits, the procedure of implementing ISO/IEC 27001 standard compliant with an ISMS deployment for GDPR compliance and discuss how to determine primary data breach risks and incident handling as per GDPR mandates.
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Supplier Quality Management (SQM) for Pharma
Ronald Torlini
60 Min
Product Id: 705743
This SQM webinar will discuss how to establish a Supplier Quality Management program from selection to approval, the ON-going maintenance and disqualification of suppliers will be explored through definition of supplier classifications. How to build risk management into the process will be discussed. The webinar will explore the use of Quality Agreements to manage suppliers.
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510(k) Documentation Best Practices for Software or Software Enabled Medical Devices
Nancy Knettell
60 Min
Product Id: 705734
This course on 510K documentation for software or software enabled device will detail what Medical Device companies need to know what Software Specific documentation needs to be prepared for successful 510K submittals to avoid delays or denial of the 510K approval. it will discuss key to comply with IEC62304, FDA guidance with in software development and verification/validation process.
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CAPA Simplified - A one-form, easy-to-complete, method for simplifying your CAPA Process
Denise Wrestler
60 Min
Product Id: 705717
This CAPA evaluation, implementation and integration webinar will discuss FDA regulatory requirements, how to evaluate your CAPA system, how to integrate with QMS and the best practices approach to initiation, evaluation and implementation of CAPA system along with discussion about CAPA documentation requirements.
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How to Perform a HIPAA Risk Assessment
James B Wener
60 Min
Product Id: 704058
This risk assessment training will discuss why it is essential to perform a risk assessment and what kind of breaches can occur. It will also list what HIPAA regulations require and what it should tell you.
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Water System Investigation "How-To's" and Example Case Studies
T.C Soli
90 Min
Product Id: 701585
In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process.
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MIPS Planning for 2019 - The Impact of the Bipartisan Budget Act of 2018
Michael Stearns
90 Min
Product Id: 705736
In this webinar the presenter will review the known and anticipated 2019 MIPS requirements for 2019 at a detailed level. It will also address how the Bipartisan Budget Act of 2018 will impact planning and performance in the MIPS in 2019. Discussion will be on the best practices for performance in each of the 4 MIPS performance categories at a granular level, including quality measure selection, implementation and performance tracking, strategies designed to obtain 100% scores on the Promoting Interoperability (formerly Advancing Clinical Information) and Improvement Activity categories, and optimizing performance in the Cost category of MIPS.
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OSHA's New Injury Recordkeeping E-Submission Rule
Joe Keenan
90 Min
Product Id: 705708
This OSHA 300 log recordkeeping webinar will discuss the new injury recordkeeping E-submission rule requirements & a basic review of recordkeeping in terms of site specific case scenarios will be presented.
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Good Manufacturing Practices and Audit Best Practices
Rama Rao
90 Min
Product Id: 705745
This webinar will discuss the fundamentals requirements for system which gets audited during FDA inspection and how to conduct internal audit, report writing and audit follow ups.
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Cybersecurity Exploitation Recovery for Medical Device Software
Casper Uldriks
75 Min
Product Id: 705729
This webinar provides initial guidance on how to build a cybersecurity recovery program that includes FDA CAPA elements. The training will address how to prepare a firm's staff for cybersecurity problems. Remember, people carry the biggest "open door" for a hacker. You can use FDA's optional follow-up options. Finally, you can take away a basic checklist that a cybersecurity audit team should include in their program. It is a start from which you can further develop and refine a cybersecurity program as you gain experience.
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Overview of Medical Device Regulation in Europe
Rebecca Kemble
90 Min
Product Id: 705566
The course is designed to review critical elements of the new regulations and is suitable for clinical, regulatory and quality leaders. The course is suitable to anyone who is new to Medical Devices, in addition to those who would like to further their working knowledge of current requirements.
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Exploring Excel: Accessing Data from SQL, Databases and Text Files
David H Ringstrom
90 Min
Product Id: 705632
Extracting data from text files or from database management systems, such as Microsoft Access or Microsoft SQL Server, can be intimidating to Excel users. In this informative session, Excel expert David Ringstrom, CPA, walks you through the process of getting the data you need from databases or from text files into Excel.