Process Validation (101) in ISO 9001/Quality/Risk Management
What you'll learn
- Understand and apply the state of the art technique on process validation.
- Understand when it is necessary, convenient or just an option, to validate a process.
- Create a User Requirement Document.
- Create a Master Validation Plan.
- Create a Validation Protocol.
- Perform the Equipment Qualification.
- Perform the Istallation Qualification.
- Performe the Operational and Performance Qualification.
- Know when and how to use the retrospective validation.
- Know when re-validate a process.
- Better understand the requirements of ISO 9001 or Six Sigma with respect to process validation or process control.
- Be employed in positions of responsibilities in companies with processes that need validation.
- Be employed in positions of responsibilities in companies with mass production.
- Be employed in positions of responsibilities in companies working in regulated fields like aerospace, automotive, pharmaceutical, food, and medical industries.
- Know what a Gaussian distribution is.
- No particular knoledge, but passion to learn. The course is for beginners.
Process Validation is the most widely used technique in order to guarantee that a process yields the desired outcome over time.
It can be applied to virtually any types of processes, both manufacturing and service processes, and it is often required by international standards (like ISO 9001), and by applicable legislation, like in the medical devices or pharmaceutical field, automotive, food, aerospace, and so on.
Whatever the field, its application can be summarized in few basic steps and tools, whose comprehension enable you to perform almost every Process Validation required in the industry.
In this course, I will guide you through these principles and techniques with plain words and clear examples, so that at the end of the learning experience, you will be able to understand and apply these principles to your field of interest.
This knowledge is valuable both to managers and engineers involved in production processes, quality management, six sigma, and in general in any activity which required that a process yields specific outcomes over time in a reliable way.
Therefore... let us get started!
Who this course is for:
- Managers in production industries
- Quality Assurance or Quality Control professionals
- Quality Engineers
- Production Engineers
- Process Engineers
- Managers and Engineers working in aerospace, automotive, pharmaceutical, food, and medical industries
- Regulatory Affairs managers and engineers
- Professional engaged in ISO 9001 or Six Sigma
- Students and people who want to develop their career in one or more of the fields above
Marco Catanossi lives and works in Italy.
He has a MSc in electronics engineering, is a Certified professional in Engineering, and he is an expert in product legislation, international standards and certifications, helping many companies from different countries to successfully put their product on the market and reach safety and quality goals.
The Author has also experience as assessors on product legislation and international standards on behalf of the Court of Justice and he is member of the European Union engineering panel for innovation projects evaluation.
Since 2008, Marco has built a consulting business helping manufacturers from different fields (from medical devices to machinery and toys) to meet regulatory and technical requirements worldwide, and to certify their organization according to management standards, like ISO 9001 and ISO 13485.
He is a dedicated professional with a high specialization in products legislation (including electrical/electronics) and certifications (both for quality like ISO 9001 and for products like IEC 60601, IEC 60335, etc.), a deep insight in product liability and a strong practical approach to product engineering and design.