This Design control webinar will explain the methods to implement or evaluate a compliant design control system.
Why You Should Attend:
Design Control is a major requirement of the GMPs and one of the four top areas for a QSIT-based U. S. FDA cGMP compliance audit. Yet many companies receive far too many 483 observations for lack of compliance. Why? What is missing? What are the areas to focus or beef up? Senior management often complains of projects that are delayed, or over budget. Can both concerns be managed under the umbrella of "Design Control"? What are the required deliverables? What are the desired deliverables?
Attend this webinar to know common areas for compliance problems based on past FDA audits and Warning Letters. How these can be addressed. Use of Design Control to add predictability to the R&D process. Learn a simple method to define the "Start Date". A typical list of Milestones and Tasks for a project. Address senior management's common complaint of projects that are delayed or over budget by using Design Control to 1) show regulatory compliance, and 2) improve on fast cycle development, while 3) controlling IP (Intellectual Property). Expected deliverables under 1) the GMPs, and 2) ISO 9001/13485. Where to use ISO 14971. Can both concerns be managed under the umbrella of "Design Control"?
This webinar will provide valuable assistance to all regulated companies that desire methods to implement or evaluate a compliant Design Control system. How to recognize the most common industry problems and likely system failure sources / locations in design control and correct. Develop and use a repeatable project template.
Areas Covered in the seminar:
- FDA Requirements.
- Typical Areas of Non-compliance.
- The "Start Date".
- Fast Cycle Development and Design Control.
- A Suggested List of Milestones and Tasks".
- ISO 14971's Role in Design Control.
- FDA Deliverables.
- ISO / MDD Deliverables.
Who will benefit:
This webinar will provide valuable assistance to all regulated companies that desire methods to implement or evaluate a compliant Design Control system. How to recognize the most common industry problems and likely system failure sources / locations in design control and correct. Develop and use a repeatable project template. This information applies to personnel / companies primarily in the Medical Device and Diagnostic fields, but the principles apply to all industries, regulated or not. The employees who will benefit include:
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- Engineering
All personnel involved in product development, engineering, Marketing, QA, and regulatory affairs, pertaining to regulated medical products, primarily devices.
Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
