Why Should You Attend:
An inadequate validation in Design Control often results in failure to meet the needs of the user, resulting in poor sales and wasted design efforts.
Much can be learned from FDA’s Warning Letters on FDA’s regulations including Design Control 21CFR 820.30, Corrective and Preventive Action (CAPA) 21CFR 820.100 as well as Production and Process Control 21CFR 820.70. Besides the damage to the company from posted, public adverse interaction from FDA, there is the financial damage to the bottom line from recalls and waste from inadequate production & processes. Adherence to the requirements of verification and validation will prevent this and will improve the efficiency of your processes. The bonus is you will save money and add to the bottom line instead of taking away $$ from the bottom line.
Areas Covered in the Webinar:
Who Will Benefit:
John Chapman, BS, MBA, RAC has over 35 years’ medical device regulatory experience and over 15 years’ experience with the European Union’s medical device directive, 93/42/EEC. Mr. Chapman has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence for over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification
(RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.
Mr. Chapman has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, auditing, root cause analysis, design control, bloodborne pathogens, hazardous waste handling, and FDA regulations. He has also presented live online seminars on various regulatory and quality system subjects.
FDA regulations as well as European standards such as ISO 13485:2016 require both verification & validation documentation throughout these regulations and standards. The terms apply to design control, process control and others. Numerous warning letters on this subject has been issued by FDA to well-known manufacturers. Verification and validation also appear in the “essential requirements” in MDD 93/42/EEC, ISO 13485:2016 and now Regulation (EU) 2017/745 needed for CE marking medical devices in the European Union. Good engineering practices in all industries benefit from well executed verification and validation studies.
This presentation will define and explain the differences (& similarities) in these terms and how they apply to regulated industries as well as the consequences of poor adherence
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