IQ, OQ, PQ - Verification, and Validation for Medical Devices

IQ, OQ, PQ - Verification, and Validation for Medical Devices

Actions and Detail Panel

$449

Date and time

Location

Online event

Refund policy

IQ, OQ, PQ - Verification, and Validation for Medical Devices

About this event

Date: Aug 26, 2022.

Time: 10:00 AM ET to 4:00 PM ET

Duration: 6 Hrs.

Level: Intermediate to Advanced

Code: OFF20

Group Packages: Please contact ben@complyrules.com

Description

Verification and validation are important elements of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn which processes needed to be validated and what steps are required to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. A validated process is optimized to ensure predictable and improved quality and compliance results.

Why Should You Attend:

Failure to validate is a significant cause of 483 observations. Even worse, it can result in customer complaints, adverse events, and even recalls. In this webinar, you’ll learn how to avoid these problems and use validation concepts to optimize processes ensuring stability and control. You’ll understand the benefits and impacts of validation and how it can benefit your customers and your business. We’ll cover tools and techniques that can help you successfully validate your processes.

Areas Covered in the Webinar:

  • Regulations and regulator expectations
  • Purpose, scope, and benefits of process validation
  • Lessons learned and enforcement case studies
  • Common problems and easy solutions
  • Important documentation
  • When to verify and when to validate
  • Steps for successful validation
  • Linkages within your Quality System
  • Best Practices
  • Preparation for FDA inspections

Who Will Benefit:

  • Manufacturing Engineers
  • Process Engineers
  • Quality Engineers
  • Supplier Engineers
  • Design Engineers
  • Engineering Managers
  • Quality Managers
  • Auditors
  • Compliance Specialists

Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.

  • In-Person Seminar going Virtual with increased learner satisfaction.
  • Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:
  • Our enhanced delivery process and technology provides you with an immersive experience and will allow you to access:
  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at different times and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding

Additional service: (Personalized session)

We also do various similar customized events for our clients and it is specially tailored as per the client's requirement. We arrange calls between clients and our course instructors to better understand the training requirement and accordingly a training program is designed. The course duration ranges between 90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3 days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation, Clinical compliance, and almost everything that falls under Risk, Quality and Compliance arena in the Life Science industry.

If you think that your team needs some kind of boost, update or refresher in Risk management and Regulatory compliance then let me know and we can design a highly cost efficient program for you.

Share with friends