ISO 27001: The risk assessment, control selection and risk treatment plan
Alan Calder
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.
Internal Audit and Risk Mitigation - Effective and practical use of the COSO and COBiT methodologies
Vic Datta
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.
Implications of the US PATRIOT Act for international financial services agencies
Kenneth Barden
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.
ISO 27001: Relationship to other standards - ISO 17799, ISO 20000, CobiT, and the integrated management system
Alan Calder
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.
CE Marking Medical Devices: New Approach Directives (NAD) To Consider for Full Compliance
Trevor Lewis
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.
FDA's cGMPs for the 21st Century Initiative
Betty Jones
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.
IT Governance and Controls for FDA & SOX compliance: The single solution
James Robertson
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.
Service Providers and SAS 70 Reports Understanding Requirements, Compliance and Benefits
Alyssa Martin
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.
Radiation Dose Setting - Method 1
Joyce Hansen
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.
A Review of Sarbanes-Oxley's Impact on IT in Year Three
George Spafford
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.
Leveraging best-practice frameworks to simplify regulatory compliance
Alan Calder
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.
Reduce the cost of Sarbanes Oxley Compliance using Control Automation
Arthur Stewart
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.
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
David Nettleton
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).
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
David Nettleton
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.
Impact of Recent Immigration Developments on Employers
Sameer Khedekar
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.
Current Regulatory Requirements for Sterile Products
Kenneth Christie
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.
The Regulatory Expectations for Environmental Monitoring Programs
Kenneth Christie
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.
Challenges of an Effective Change Control Program
Kenneth Christie
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.
Auditing Business Continuity Plans According to ISO 22301
Michael C Redmond
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.
Basic Requirements for IQ, OQ and PQ Protocols
Kenneth Christie
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.







