This presentation will cover the FDA regulations (21 CFR Subpart G Section 820.70) regarding production and process controls and how each requirement listed within the regulation can be addressed. We’ll go over examples of documentation you can use to fulfill the requirements of this section, as well as tips and tricks to what FDA auditors will look for when they come to visit your site. We will also go over some additional tips and tricks on how to convey the importance of maintaining production and process control within your organization and ensure resources are provided to meet process needs. At the end of the presentation, Speaker will answer any questions or concerns you may have regarding FDA requirements.
Why You Should Attend:
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.
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.
- Regulatory requirements for production and process controls
- Responsibilities of manufacturers
- Best practices for implementation
- FDA expectations
- Documentation requirements
- Quality Assurance Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Production Departments
- Documentation Departments