Setting up a Risk-Based Audit Program: What to Consider and Why?
4:00 PM – 5:30 PM, Central European Time (CET)
10:00 AM – 11:30 AM, Eastern Time (ET)
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Overview
Setting up an audit program for internal and external audits is a basic process for almost any business. It simply includes identifying the areas that need to be audited, how often each area needs to be assessed, and, importantly, the standards they each need to be audited.
However, problems can often arise when setting up an audit program that is truly fit for purpose – which means setting up an audit program based on risk. For this approach to be successful, the whole audit process needs to be viewed from a different angle that ultimately reduces or eliminates the risk for all stakeholders – whether it is a financial risk, business credibility or reputational risk, or, most importantly, a health risk!
The problems are often due to the lack of good insights and true understandings that a company has about the extra tangible benefits a risk-based approach can make to the business. Having this insight and deeper understanding of risk can not only save you the time (i.e., money) that is often lost due to having inadequate audit results or insufficient audit data resulting from a lack of audit depth (both of which may result in a re-audit being required) – but it can save lives too! As a bonus, it shows your peers and clients that best practice is part of your business’s quality culture.
Therefore, the solution to a weak audit program is to strengthen it by employing a robust and detailed risk-based approach. This means having access to expertise in the field of risk analysis and risk management principles. It also means having access to experts with a deeper understanding of what big and small businesses are looking for when making these best practices a substantial part of your business’ DNA. Good insight and knowledge and an understanding of ‘why’ you should employ a risk-based approach will make all the difference. It is a win-win scenario for all involved and helps push boundaries and ensure a culture of continual improvement is organically interwoven throughout your business.
This webinar will help you gain in-depth knowledge of what to consider when setting up an audit program (internal and external) within a GDP or GMP environment, specifically about factoring in risk analysis methodologies. In addition to understanding ‘what’ is important, you will understand precisely ‘why’ this is important, why we must consider the wider risk element, and why reducing its overall impact is critical to its success.
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Who Should Attend:
- QA Managers
- Department heads
- Quality Auditors
- GDP Trainers
- Risk Assessors
- RPs (Responsible Persons)
- Skill Level: Intermediate , Expert
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Topics:
- The current climate in auditing
- Growth of the international supply chain and its expectations
- Primary areas of concern and how to address them
- The benefits of employing a risk-based approach
- What do you need to do and why
- The importance of strong quality culture and how risk reduction is key
- Q&A -
Special event information:
All participants will get a free certificate of attendance courtesy of our event's sponsor Qualifyze.
Speaker
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Chris MartinQuality Specialist & GDP AdvisorChris has spent more than 30 years working within the logistics supply chain, covering the manufacturing, storage and distribution arenas. For the last 15 years Chris has focused entirely on quality management within the pharmaceutical supply chain, working alongside many of the world’s leading pharmaceutical companies helping to advise on and develop their global supply chain management procedures across multiple modes of transport, including air, sea and road.
Chris has successfully led quality departments as either ‘Senior Quality Manager’ or ‘Head of Quality’ throughout his time working in the pharmaceutical supply chain and as an experienced Responsible Person, managing multiple sites, he has always played a leading role in the designing, production and training out of GDP regulations and other quality best practice disciplines to colleagues, clients and third party suppliers alike. Chris has a strong foundation and deep understanding of Quality Management Principles honed over many years working in the healthcare arena and has a genuine passion in sharing his acquired knowledge with others throughout the industry. Chris has always possessed a strong focus on the importance of quality culture within business and has always taken particular enjoyment in helping others involved throughout the end to end supply chain, guiding them in how best to manage change and improve on their own quality compliance skills.
As an experienced auditor of the pharmaceutical supply chain, Chris is skilled in seeing where potential regulatory gaps exist and in driving continual improvements for clients and third-party subcontractors alike, helping them to reduce risk and align themselves with all things GDP related.
Partner
Qualifyze
Website
http://www.qualifyze.comThe Qualifyze mission is to build the trust layer for global supply chains by creating a digitally connected ecosystem. They operate the first online platform for GxP audits that connects pharma companies, suppliers, and auditors.
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