Leveraging SOX Anti-Fraud Programs to Reduce Company-Wide Risks
Peter Goldmann
60 Min
Product Id: 700938
The training supports SOX Compliance (particularly Section 30 as it pertains to anonymous hotlines), and conforms to key criteria of the revised US Federal Sentencing Guidelines. Know how to promptly and effectively REPORT incidents of fraud or suspicious conduct.
SOX: Internal Controls for Inventory
Mike Morley
60 Min
Product Id: 700359
Effective internal controls keep track of inventory and ensure that its proper value is reflected on the financial statements This presentation will provide you with the tools you need to establish and maintain strong internal controls for Inventory that meet Sarbanes-Oxley standards
IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER
E.J Smith
60 Min
Product Id: 700956
This presentation covers all of the steps one should take when beginning the IDE process for a PMA.
Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements
E.J Smith
60 Min
Product Id: 700955
This class reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.
How to Prepare and Submit a Bullet Proof 510(k) Submission
David Dills
60 Min
Product Id: 700981
This webinar will provide valuable assistance and guidance to all medical device companies that are preparing and submitting 510(k)s to FDA for review and approval.
Security Standards ISO 27001 and 27002: What they are and how to use them
Diana Kelley,Ed Moyle
Product Id: 700868
In this webinar, ISO certified lead auditor for 27001, Ed Moyle, and Diana Kelley, Partner at Security Curve, will explain how organizations can use the ISO standards as a baseline for their security and risk management program. This webinar will provide valuable assistance to all companies are building and maintaining information security management systems.
The Employment Law System and how to stay above the legal line
Scott Baird
60 Min
Product Id: 700810
In this webinar we will cover the legal principles developed by the common law concerning employee privacy, the major anti-discrimination laws.
Pharmacovigilance aspects of licensing agreements
Dr.Sidney Kahn
60 Min
Product Id: 700928
Regulatory expectations for reporting in multi-company development and marketing programs.
Virtualization Compliance Assessment (ESX Server and PCI/DSS 1.1)
Michael Hoesing
60 Min
Product Id: 700878
In this presentation each on the categories and requirements of the PCI/DSS standard 1.1 will be compared to settings within the Virtualization configuration of a VMware ESX Server 3.x machine. Security professionals who wish to have a closer look at the security settings possible on a virtualization host for consideration when crafting detailed policies.
Computer System Auditing 21CFR Part 11 Compliance
Richard Poser(PhD)
60 Min
Product Id: 700884
The webinar will address each audit item and train the participants how to determine the compliance status. We will use common examples of non-compliance observations from actual audits and suggest remediation plans that are compliant, efficient and economical.
Utilizing ICH Guidelines for GCP Regulatory Compliance
Carl Anderson
60 Min
Product Id: 700855
This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.
Complying with 21CFR Part 11-Understanding the Role of Predicate Rules
Tony Dunbar
60 Min
Product Id: 700177
AN overview of the Part 11 regulation, with special emphasis on the key role played by the applicable predicate rules as the starting point for any Part 11 compliance assessment. In spite of the FDA’s clarification regarding the scope of electronic records subject to Part 11 as expressed in the Sep 2003 Guidance for Industry, much discussion and debate still surround the topic.
Preparing Compliant eCTD Submissions
Antoinette Azevedo
60 Min
Product Id: 700719
This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions. The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products.
HR Compliance Requirements for small Companies
Matthew W Burr
60 Min
Product Id: 700649
This webinar will cover Federal Labor Laws by number of employees and adherence to State Laws.
Introduction to Defense Trade Controls, ITAR - best-practice strategies to make your program compliant and effective
Natascha Finnerty
60 Min
Product Id: 700696
This presentation will present the major items that your company’s Technology Control Plan and Compliance program must contain. Emphasized are best-practice strategies to make your program compliant and effective.
The latest approach for complying with 21 CFR Part 11
Sam Mistretta
60 Min
Product Id: 700664
This 21 CFR Part 11 training/webinar will provide valuable assistance to all regulated companies that need to comply with 21 CFR Part 11.
Overview of the Harmonized Tariff Schedule of the United States - Classifying Your Products for Customs Purposes
Paula Connelly
60 Min
Product Id: 700659
This Harmonized Tariff Schedule of the United States training/webinar will provide an overview of the structure of the HTSUS and how to use the HTSUS to determine the correct classification, duty rate, and possible quotas, restrictions or preferential duty rates that may be applicable to your product.
Sarbanes-Oxley, IT and Segregation of Duties
George Spafford
60 Min
Product Id: 700112
This segregation of duties (SOD) training/webinar in Sarbanes-Oxley and IT will provide an overview of the current interpretation of Sarbanes-Oxley and will talk about what risks that Sarbanes-Oxley is especially concerned with when it comes to segregation of duties.
Interviewing and Hiring in Compliance with Federal and State Laws
Marna Hayden
60 Min
Product Id: 700647
The HR Compliance training/webinar in Interviewing and Hiring will cover various interviewing techniques and the processes used to make effective selection decisions.
FDA's cGMPs for the 21st Century Initiative
Betty Jones
60 Min
Product Id: 700620
This FDA’s cGMPs training/webinar will provide and insider’s view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches.







