This Medical Device training will describe the information needed to write such protocols, and the basic contents of those protocols. This webinar will provide valuable assistance to all regulated companies that need to validate their manufacturing processes.
All equipment needed to manufacture medical devices must be validated prior to distribution and sale of the devices. Also, the process by which these devices are manufactured must also be validated. This medical device training will describe the information needed to write such protocols, and the basic contents of those protocols. This presentation will not cover the validation of software used during the manufacturing process.
All equipment needed to manufacture medical devices must be validated prior to distribution and sale of the devices. Also, the process by which these devices are manufactured must also be validated. This medical device training will describe the information needed to write such protocols, and the basic contents of those protocols. This presentation will not cover the validation of software used during the manufacturing process.
Areas Covered in the seminar:
- What needs to be validated.
- Why validation is necessary.
- What information is needed prior to writing a validation protocol.
- What types of protocols are needed: IQ, OQ, PQ, Gage R&R, TMV.
- Basic components of a validation protocol.
- Additional components.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate their manufacturing processes. The employees who will benefit include:- End-users responsible for applications that need to be validated
- A managers and personnel
- Validation specialists
- Consultants
- Quality system auditors
Course Provider
Lawrence Spritzer,
