WEBINARS

 

Leveraging SOX Anti-Fraud Programs to Reduce Company-Wide Risks

webinar-speaker   Peter Goldmann

webinar-time   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.

Recording Available

* Per Attendee $199

 

SOX: Internal Controls for Inventory

webinar-speaker   Mike Morley

webinar-time   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

Recording Available

* Per Attendee $199

 

IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER

webinar-speaker   E.J Smith

webinar-time   60 Min

Product Id: 700956

This presentation covers all of the steps one should take when beginning the IDE process for a PMA.

Recording Available

* Per Attendee $249

 

Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements

webinar-speaker   E.J Smith

webinar-time   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.

Recording Available

* Per Attendee $249

 

How to Prepare and Submit a Bullet Proof 510(k) Submission

webinar-speaker   David Dills

webinar-time   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.

Recording Available

* Per Attendee $249

 

Security Standards ISO 27001 and 27002: What they are and how to use them

webinar-speaker   Diana Kelley,Ed Moyle

webinar-time  

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.

Recording Available

* Per Attendee $249

 

The Employment Law System and how to stay above the legal line

webinar-speaker   Scott Baird

webinar-time   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.

Recording Available

* Per Attendee $149

 

Pharmacovigilance aspects of licensing agreements

webinar-speaker   Dr.Sidney Kahn

webinar-time   60 Min

Product Id: 700928

Regulatory expectations for reporting in multi-company development and marketing programs.

Recording Available

* Per Attendee $249

 

Virtualization Compliance Assessment (ESX Server and PCI/DSS 1.1)

webinar-speaker   Michael Hoesing

webinar-time   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.

Recording Available

* Per Attendee $249

 

Computer System Auditing 21CFR Part 11 Compliance

webinar-speaker   Richard Poser(PhD)

webinar-time   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.

Recording Available

* Per Attendee $249

 

Utilizing ICH Guidelines for GCP Regulatory Compliance

webinar-speaker   Carl Anderson

webinar-time   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.

Recording Available

* Per Attendee $299

 

Complying with 21CFR Part 11-Understanding the Role of Predicate Rules

webinar-speaker   Tony Dunbar

webinar-time   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.

Recording Available

* Per Attendee $149

 

Preparing Compliant eCTD Submissions

webinar-speaker   Antoinette Azevedo

webinar-time   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.

Recording Available

* Per Attendee $249

 

HR Compliance Requirements for small Companies

webinar-speaker   Matthew W Burr

webinar-time   60 Min

Product Id: 700649

This webinar will cover Federal Labor Laws by number of employees and adherence to State Laws.

Recording Available

* Per Attendee $149

 

Introduction to Defense Trade Controls, ITAR - best-practice strategies to make your program compliant and effective

webinar-speaker   Natascha Finnerty

webinar-time   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.

Recording Available

* Per Attendee $149

 

The latest approach for complying with 21 CFR Part 11

webinar-speaker   Sam Mistretta

webinar-time   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.

Recording Available

* Per Attendee $249

 

Overview of the Harmonized Tariff Schedule of the United States - Classifying Your Products for Customs Purposes

webinar-speaker   Paula Connelly

webinar-time   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.

Recording Available

* Per Attendee $149

 

Sarbanes-Oxley, IT and Segregation of Duties

webinar-speaker   George Spafford

webinar-time   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.

Recording Available

* Per Attendee $99

 

Interviewing and Hiring in Compliance with Federal and State Laws

webinar-speaker   Marna Hayden

webinar-time   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.

Recording Available

* Per Attendee $149

 

FDA's cGMPs for the 21st Century Initiative

webinar-speaker   Betty Jones

webinar-time   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.

Recording Available

* Per Attendee $249

 

 

 

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