Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Jack Dhuwalia
OVERVIEW:
Design Controls have been required per QSR Section 820.30 for Medical Devices. For combination products (drug & device) CFR Part 4 has been requiring compliance to several sections of CFR 820 including 820.30 (design control). The drug industry may not be as familiar with 820.30.
The device industry as well combination products could benefit from understanding why FDA is looking for design control right from start so that the submissions meet the requirements as well as assist FDA inspections because the company is well prepared and has thought about details so the answers come out with ease.
The webinar will provide systematic approach in understanding FDA’s thinking as well as practical approach to why and how to develop device without doing unnecessary work while focusing on what’s really needed. As we satisfy FDA’s needs, results will likely be positive.
Why should you Attend: The better the attendee understands what needs to be done and why to do it (Answers the question: What’s in it for me?) The webinar answers many practical questions such as how-to do it etc.
If the company knows what needs to be done – demonstrates competence, then the process becomes easier – weather it is to obtain regulatory approvals, or pass inspection as much of the discussion in the webinar addresses these areas.
For Medical Devices as well as for Combination products per 21 CFR Part 4, Design Controls are required at all stages including during design planning.
Areas Covered in the Session:
– What major items is FDA looking for in design controls?
– In particular, were Design Inputs established? When? Were the acceptance criteria established? Were design reviews specified and conducted. (They’ll look to procedures whether reviews are required?) Was verification/validation conducted and met the criteria? Was it done on product from production or equivalent?
– What will benefit the company the most?
– What policies and procedures are required to support the effort?
– Major steps per regulation
– Beyond regulations – what else is required? (This is where experience counts since the regulations don’t help much in how-to)
– Trace matrix – what is it and how to document the progress – from start to finish – so that FDA has a clear view (various stages) of project identified by key reference points including reference to results with pass/fail status identified
– For example: how to start from customer requirements to create specific product requirement for each requirement, how to look for applicable standards, create a test plan, complete the testing, reference test results, and provide traceability documented on the trace matrix. Items marked “Pass” get the ball rolling!
– Verification/Validation results with reference to protocol and reports for customer requirement (they could be aggregated into subgroups per procedure) along with review for each customer requirement puts a finishing touch!
Who Will Benefit:
– Operations Director, Manager, Sr.Staff
– Marketing Director, Manager, Sr.Staff
– R&D Director, Manager, Sr. Staff
– Regulatory Director, Manager, Sr.Staff
– Quality Assurance Director, Manager, Sr.Staff
– Validations Manager, Sr.Staff
– Engineering Director, Manager, Sr.Staff
SPEAKER PROFILE:
Jack Dhuwalia is a seasoned technical manager of his own consulting company since 1993. He addressed warning letters, implemented design control systems, prepared companies for FDA inspection, conducted many verification and validations including test method validations, packaging and sterilization validations. Previously he was a section manager for Baxter Health Care, a business development manager developing Class II and III medical devices. He brings clinical experience to help design medical products. He has two patents in Cardio-Vascular systems. He has written several technical articles and enjoys teaching at technical conferences and UCI/USC.
