WEBINARS

 

ISO 27001: The risk assessment, control selection and risk treatment plan

webinar-speaker   Alan Calder

webinar-time   60 Min

Product Id: 700300

In this Quality compliance training topics will be related to the risk assessment, control selection and risk treatment plan for developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005. This is a part of a series of webinars that support those considering or developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005.

Recording Available

 

Internal Audit and Risk Mitigation - Effective and practical use of the COSO and COBiT methodologies

webinar-speaker   Vic Datta

webinar-time   60 Min

Product Id: 700296

This Internal audit training is to align the audit risk assessment, audit ecosystem, audit plan, and audit engagements with the larger organization’s strategy, vision, and values.

Recording Available

 

Implications of the US PATRIOT Act for international financial services agencies

webinar-speaker   Kenneth Barden

webinar-time   60 Min

Product Id: 700248

In this Financial services training will examine the provisions of the PATRIOT Act that affect international financial institutions, along with recent regulations implementing those provisions.

Recording Available

 

ISO 27001: Relationship to other standards - ISO 17799, ISO 20000, CobiT, and the integrated management system

webinar-speaker   Alan Calder

webinar-time   60 Min

Product Id: 700244

In this Quality compliance training comprehensive guidance on ISO/IEC 27001:2005 that will aid and assist practitioners and managers the world over.

Recording Available

 

CE Marking Medical Devices: New Approach Directives (NAD) To Consider for Full Compliance

webinar-speaker   Trevor Lewis

webinar-time   60 Min

Product Id: 700136

In this Medical device training will provide an explanation of what a New Approach Directive is and what they all have in common from a compliance perspective. The placing of a CE mark on a medical device implies compliance with all European "New Approach" directives that apply and typically three or four directives will have to be considered.

Recording Available

* Per Attendee $249

 

FDA's cGMPs for the 21st Century Initiative

webinar-speaker   Betty Jones

webinar-time   60 Min

Product Id: 700156

This presentation will provide and insiders view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches In 2002, FDA announced a significant new initiative, Current Good Manufacturing Practices (cGMPs) for the 21st Century intended to modernize FDA’s regulation of pharmaceutical quality and established a new regulatory framework for manufacturing.

Recording Available

* Per Attendee $249

 

IT Governance and Controls for FDA & SOX compliance: The single solution

webinar-speaker   James Robertson

webinar-time   60 Min

Product Id: 700188

How a common COBIT-based IT control solution can satisfy multiple regulatory and business requirements. This seminar will show you that a common IT control solution should be available to satisfy multiple regulatory and business requirements.

Recording Available

* Per Attendee $249

 

Service Providers and SAS 70 Reports Understanding Requirements, Compliance and Benefits

webinar-speaker   Alyssa Martin

webinar-time   60 Min

Product Id: 700189

This SAS 70 training will provide a Process of SAS 70 Audit, frequency & formatting of documenting controls in COSO and COBIT and SAS 70 Report types and impact of Sarbanes-Oxley to create the demand for SAS 70 audits.

Recording Available

* Per Attendee $249

 

Radiation Dose Setting - Method 1

webinar-speaker   Joyce Hansen

webinar-time   60 Min

Product Id: 700119

The steps for conducting Method 1 and identifying typical issues that might arise when conducting the test method. This presentation is the first of three presentations on the methodologies for the determiniation of the minimum sterilization dose.

Recording Available

* Per Attendee $249

 

A Review of Sarbanes-Oxley's Impact on IT in Year Three

webinar-speaker   George Spafford

webinar-time   60 Min

Product Id: 700111

This SOX compliance training will benefit public companies who are either embarking on their Sarbanes-Oxley compliance journey or are struggling with sustaining their current control environment.

Recording Available

* Per Attendee $249

 

Leveraging best-practice frameworks to simplify regulatory compliance

webinar-speaker   Alan Calder

webinar-time   60 Min

Product Id: 700102

This regulatory compliance training will help in frame working and Leveraging best-practices in the way of the business in a cost effective manner. Organizations face complex and rapidly evolving regulatory requirements, which have to be met within an equally fast-changing information threat environment.

Recording Available

* Per Attendee $249

 

Reduce the cost of Sarbanes Oxley Compliance using Control Automation

webinar-speaker   Arthur Stewart

webinar-time   60 Min

Product Id: 700068

This Sarbanes Oxley Compliance (SOX) training is targeted at compliance and risk managers who are looking to leverage leading technology to increase quality and reduce the costs of compliance and process management.

Recording Available

* Per Attendee $199

 

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

webinar-speaker   David Nettleton

webinar-time  

Product Id: 701687

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

Recording Available

 

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

webinar-speaker   David Nettleton

webinar-time  

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.

Recording Available

 

Impact of Recent Immigration Developments on Employers

webinar-speaker   Sameer Khedekar

webinar-time  

Product Id: 705344

Recent changes impact not only the employment of foreign nationals, but the broader workforce comprised of green card holders and international travelers. Executive leadership is looking to compliance officers, legal departments and human resources to understand how these changes affect their company. Tune in to learn how to ensure your business is not adversely affected by changes in immigration legislation and policy.

Recording Available

 

Current Regulatory Requirements for Sterile Products

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 703672

This webinar will highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

Recording Available

 

The Regulatory Expectations for Environmental Monitoring Programs

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 703648

Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.

Recording Available

 

Challenges of an Effective Change Control Program

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 704638

This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.

Recording Available

 

Auditing Business Continuity Plans According to ISO 22301

webinar-speaker   Michael C Redmond

webinar-time  

Product Id: 704410

This training will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO. Participants will understand what’s involved in a full BCP program and have insights based upon field experience that can be applied to Internal Audit work and BCP. The session will provide you with tools that you can bring back to your company to improve upon BCP programs & ability to audit them to provide targeted recommendations.

Recording Available

 

Basic Requirements for IQ, OQ and PQ Protocols

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 704591

This training program will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. It will highlight the importance of establishing specifications for all test challenges, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.

Recording Available

 

 

 

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