The criticality of validation to the Quality System Regulations and ISO 13485 can never be understated. Failure to validate attracts 483 observations from the FDA. Failure to validate has other consequences as well: it results in customer complaints, adverse events, and even product recalls. It thus bears no repetition that ingraining and implementing the essentials of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Validation are absolutely essential for regulated companies.
Which are the essentials of IQ, OQ, and PQ Validation that these regulated companies need to comprehend and implement into their Quality Systems? These highly valuable points will form the topic of a very crucial learning session that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing. Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the speaker at this session.
To register for this highly interactive and beneficial webinar on the essentials of IQ, OQ, and PQ Validation, which is being organized on April 30 and is of 90 minutes’ duration, please visit https://t2m.io/rR8THr4S.
The core of the learning that Susanne will impart at this session on the essentials of IQ, OQ, and PQ Validation is on how to avoid the problems associated with improper IQ, OQ, and PQ Validation and to use validation concepts to ensure process stability and control.
At this course on the essentials of IQ, OQ, and PQ Validation, Susanne will explain the requirements that go into validation. She will give a thorough understanding of what processes need to be validated and what steps organizations in the regulated areas should take to validate processes. The essentials of validation planning, protocol writing, and change management will be explained.
This session will cover the steps for IQ, OQ, and PQ. The core of the learning on this area of this webinar are tips and best practices, the benefits and impacts of validation, and how participants’ customers and business can benefit from these. Also covered at this session on IQ, OQ, and PQ Validation are the tools and techniques that can help in successfully validating a regulated company’s processes.
This session will cover the following areas:
- Purpose, scope, and benefits of process validation
- FDA Expectations, Regulations
- Lessons learned and enforcement case studies
- Common problems
- When to verify and when to validate
- Process and steps for validation
- Linkages to your Quality System
- Master Validation Planning
- Best Practices.
Professionals such as Manufacturing Engineers, Process Engineers, Quality Engineers, Engineering Managers, Quality Managers, Auditors, and Compliance Specialists will find this webinar on the essentials of IQ, OQ, and PQ Validation highly useful.
About the speaker: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.