Medical Device Process Validation Training for Professionals
Course Director
Course Fee
$2650.00 Regular Registration
$2450.00 Early Bird Pricing (Register 30 Days in Advance)
Future Live Stream Sessions (click to register)
Process Validation Medical Device, Course Description
This medical device process validation course equips participants with in-depth guidance on developing and implementing an effective process validation system for risk-based compliance and product safety in medical device manufacturing. The course also addresses the unique considerations and regulatory expectations for combination products.
Participants will explore why process validation principles and applications are essential for product quality and regulatory compliance. Through interactive discussion and real-world examples, attendees will learn how a compliant validation program supports product quality.
Issues in this medical device validation principles and application workshop include:
- Developing validation processes best practices
- Identifying and remediating gaps
- Improving process system knowledge and understanding
- Developing a plan to rectify existing validation plans, protocols and reports
- Implementing and deploying a master validation plan
Attendees are encouraged to bring examples of Process Validation issues or concerns they would like to have reviewed and discussed during the course.
Why Process Validation for Medical Device Training Course Matters?
The guideline on "General Principals of Process Validation" was issued in May 1987, and since then, medical device companies have struggled with the principles of process validation. Internationally, regulators believe that through careful design and validation of the process and appropriate process controls, a manufacturer can establish a "high degree of assurance" that all manufactured units from successive lots will be acceptable.
Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing. More recently, with the introduction of risk management to medical devices, it is important to correctly apply the principles of risk management when implementing and maintaining process validation activities.
Newer products and processes pose additional challenges to organizations. New processes are more complex thereby making process validation more difficult. Using the tools developed in this process validation for medical device manufacturing course, participants will be able to methodically plan and conduct protocol assurance.
Who Should Attend
This 20-hour medical device manufacturing validation training is targeted toward medical device professionals directly involved in meeting International and FDA's Quality System requirements, specifically relating to process validation.
Typical attendees include:
- Professionals in Regulatory Affairs
- Quality Assurance and Control
- Auditing and Compliance Engineering
- Process Development
- Quality Engineering
- Manufacturing Engineering
- Design and Development Engineering
- Documentation Control Specialists.
To maximize peer learning opportunity, this medical device process validation course is recommended for those who may have a core level of understanding of medical devices, the Quality System Regulation (QSR) and/or ISO 13485, with some direct work experience.
This process validation training course provides attendees with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation (CFR 820), and the Quality System standard ISO 13485 while providing direction on how to implement an effective process validation program.
Process Validation Medical Device Certification Tracks
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.