How to Establish an Effective IT Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities
Michael C Redmond
Product Id: 704991
This training program will discuss how to develop a great GRC program that ensures proper governance, risk management and compliance management of all IT systems and processes that support the business operations.
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.
Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products
Kim Huynh-Ba
Product Id: 704421
This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.
10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting
David Nettleton
Product Id: 701583
Understand the 10-step risk based approach to validation, explore methods to decrease resource requirements, and learn how to make documentation more manageable and understandable.
Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data
Barry A Friedman
Product Id: 705452
This webinar will discuss the main issues with FDA’s revised draft guidance on submission of quality metrics data. It will also cover the most common observations that the FDA issues within the warning letter and how these can impact your organization.
Developing a Highly Effective Enterprise Risk Management Program
Michael C Redmond
Product Id: 704827
This webinar highlights the importance of an effective ERM program in project management and risk assessment. Attendees will learn how to implement a viable ERM program including documenting and testing it.
21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s
David Nettleton
Product Id: 704533
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).







