Ensuring your company gets a broader perspective of how and what to do to get a quick and non-debatable or questionable approval for your 510K product. All are lots different so this presentation will not just be specific for a specified Medical Device that is currently being marketed and your company want the same opportunity to produce and sell that product.
Background of the Topic
Because the types of Medical Devices is changing a lot due to technology, but other companies are wanting to produce and market the same Medical Device as has already been approved by the FDA and having been marketed which requires the all the requirements and the submission of the 510K for this company wanting to get approval and be able to market this basically same product proven as a Medical Device. Knowing a much more effective approach using what will be shown in the webinar will you’re your company become successful as quickly as possible so the FDA has confidence in knowing this is truly a 510K submission with all the support needed to make sure there is NO confusion about this product meeting the requirements for approval. The submission will not be processed unless all your involvement with the FDA and the supporting documentation to generate proof that this is in compliance with the 510K expectations.
Awareness of the needed the FDA involvement and your generation of documents and objective evidence has to provide needed detail to gain easy and quick approval of a product. This discussion is intended to describe how to organize better than just getting your interpretation from the FDA 510K document.
Why Should You Attend?
Generate the technical comprehension and technical writing capabilities to eliminate corporate interpretations and translations of technical terms relative to the specifics of your specific process needed for a 510K submission. We always want to submit the submission in a way that does not require any interpretation and my delay the quick approval by the FDA, so that when the FDA reads the documents they come to the EXACT same conclusion we did to generate the production process for this product ensuring we are not generating any patient risk.
Areas Covered in the Session:
- Medical device technology is constantly evolving, and the approval for another company to produce the same approved Medical Device product requires FDA's review and approval. The new FDA 510K recommendations are intended to provide guiding principles to help manufacturers determine when an intended product or minor change to a legally marketed medical device subject to premarket notification in compliance with the 510K requirements is significant enough to warrant FDA review and approval, including major changes or modifications to the intended use that could significantly impact safety and effectiveness (patient risk)
- Whenever a manufacturer changes its device, it must take certain actions to comply with the QS regulation, 21 CFR Part 820, unless a regulatory exemption exists. The QS regulation which includes your CAPA procedure requires that design changes and production and process changes be documented and proven to be just as good and not generating any patient risk and notifying the FDA for this change from the original approval prior to implementation
- In evaluating whether a change requires a new 510(k), manufacturers have to consider whether there are any unintended consequences, needed clinical trials or effects of the device change. For example, changes in sterilization may unintentionally affect device materials, or changes to materials may unintentionally affect the performance of the device
- FDA BRIEFING Documents - The purpose of the pre-facility meeting is to provide detail and seek FDA's input regarding your company’s proposed new manufacturing facility or the new manufacturing process, single use disposable manufacturing technology and to confirm that the proposed approach will provide adequate comparability data between the product that was proven to be functional based on the clinical results and now as is going to be used for commercial manufacturing in the new facility since the product produced in the pilot facility and used for the initial Phase II/III clinical trials
- The purpose of the pre-facility meeting is to provide detail and seek FDA's input regarding your company’s proposed new manufacturing facility or the new manufacturing process, single use disposable manufacturing technology and to confirm that the proposed approach will provide adequate comparability data between the product that was proven to be functional based on the clinical results and now as is going to be used for commercial manufacturing in the new facility since the product produced in the pilot facility and used for the initial Phase II/III clinical trials
BioPharmaceutical Consulting and Life Coach ,
JD Technologies, LLC
Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.
He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.
- Regulatory Affairs Managers, Directors and VPs
- Clinical Affairs Managers, Directors and VPs
- Quality Managers, Directors and VPs
- Compliance Managers and Directors
- Complaint Handling and Risk Management Managers and Directors
- Site Managers, Directors, and Consultants
- Legal Counsel
- Quality Assurance
- Product Development
- Executive Management, such as CEO, Owner, President, Vice President
- Regulatory specialists who compose 510(k) applications for software
- Manufacturers of medical devices
- Project managers and documentation specialists
- Medical writers