Production and Process Controls - Ensuring Your Medical Device Conforms to its Specifications
Date: Wednesday, 27 February 2019
Time: 10:00 AM PST, 01:00 PM EST
Duration: 60 Minutes
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Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. P&PC is critical to producing safe and effective products for your customers. It is a broad area covering environmental, personnel, contamination, building, equipment, inspection, materials, and more. Because of its criticality, P&PC is one of areas most closely inspected by the FDA. This webinar will help you understand what is necessary for P&PC and how to integrate it seamlessly with the rest of your Quality Management System.
Objectives of the Presentation
Why Should you Attend
- Regulatory requirements for production and process controls
- Responsibilities of manufacturers
- Best practices for implementation
- FDA expectations
- Documentation requirements
This presentation will help you get an in-depth understanding of what regulatory agencies such as the FDA are requiring for production and process controls as they relate to documentation, change control, environment control, personnel, contamination control, buildings, equipment, manufacturing material and automated processes. The topics and pointers within the presentation will provide the tools necessary to evaluate your already-existing processes to determine if it meets requirements and if your systems are robust enough to ensure actions are effective or overly-complicated and preventing smooth operation. We'll provide an overview of commonly-used tools, help understand some misconceptions with implementation, and provide tips and tricks for ensuring your device conforms to its specifications.
Who will Benefit
- QMS Auditors
- Quality Engineers
- Manufacturing Engineers
- Manufacturing Supervisors
- Manufacturing/ Production /Operations Supervisors, Managers, and Directors
- Plant Managers
- Quality Managers
- Employees new to Medical Device Companies
All medical device manufacturers are required to have a robust system in place to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications. Many manufacturers are overwhelmed with the requirements of 21 CFR Part 820.7 and are unsure how to comply with these regulations. Other manufacturers may have documented procedures and systems in place to meet the requirements of this section but are unsure if it's appropriate (i.e. too complex or too broad) or effective.