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Review of the Changes for ISO 13485:2016 Implementation and Comparison
- Introduction to ISO
- Introduction to ISO 13485
- Introduction to ISO13485 vs 21 CFR 820
- ISO13485:2003 vs ISO13485:2016
- Description of the changes
- Preparation to start a GAP analysis from 2003 to 2016
Overview of the webinar
The International Organization for Standardization (ISO) was established to share knowledge and develop voluntary, consensus-based, market-relevant standards that are designed to help support innovation and to provide solutions to tackle global issues. ISO is an independent, international NGO and has a membership of 162 national standards bodies.
The ISO organization established ISO13485 in a structured way that describes various departments and has develops requirements for Medical Device Industry’s QMS. In 2016, ISO updated the ISO13485 (:2003) standard. This reflected the changes in the industry and in the regulatory bodies. The standard was updated by being designed for regulatory purposes.
The standard updates included an emphasis on regulatory compliance and expected organization to meet appropriate regulatory requirements. This also was meant to increase commonality with the ISO standard and regulatory bodies. It was designed to accommodate any global standard. This allowed it to improve convergence of US FDA (21CFR820), Japan, and ISO requirements. The standard was modified to align better with the EU Medical Device Directive (MDD) needs as well. The revision was also an opportunity to converge US, Japan, and Brazil unique requirements with ISO 13485 text, making it truly global standards.
ISO13485:2016 also increased awareness of the need for the following:
- Emphasis on competency
- Record keeping
- Risk management
- Other enhancements.
This session will focus on the changes of the ISO13485:2003 in the relationship with the updated standard - ISO13485:2016
Who should attend?
- Top Management and Company Leadership
- General Manager
- Quality Manager and Quality personnel
- Regulatory Manager and Regulatory personnel
- Engineering Manager
- Engineers
- Audit Manager
- Auditors
- Purchasing Manager
- Human Resource Manager
- Document Control personnel
Why should you attend?
ISO13485 was developed to assist the global Medical Device industry, and in order to be a part of this industry a company (and its personnel) are responsible for implementation and maintenance of the ISO standards.
In 2016-2017, ISO rolled out the updated ISO13485 standard, which was last published in 2003. The update was made to reflect significant changes in the industry and in the regulatory atmosphere. It is important to know these changes and how they would affect individual organizations.
If your organization is preparing to implement and certify to ISO13485, it would be best to know the latest version of the standards. If your organization is already registered to ISO13485:2003, and looking to re-certify to the new standard, this session can help develop a gap analysis from 2003 to the new standard. This session will highlight the differences of the 2016 and 2003 standard.
Faculty - Mr.Erol Ali Cetinok
Erol Ali Cetinok has over twenty-five years of experience in various engineering, compliance, validation and quality roles. His educational background is in Mechanical Engineering and has extensive experience with quality management systems with respect to FDA/ISO standards and compliance in a regulatory environment. Erol has experience in the Life Sciences, Automotive, Telecommunications and other industries. He has filled many roles that have varied from validation protocol development and execution, product engineering, compliance consulting, quality system implementation, and quality system audits. This experience includes small and large companies operating in the US, Europe and Japan.
Erol was at Indiana University Medical School for over 6.5 years. During this time Erol served as the Quality Compliance Specialist for the Indiana University Vector Production Facility. This facility generates clinical gene therapy vector products for Phase I/II trials, and have published extensively on release testing to meet FDA requirements. Erol was responsible for two Drug Master Files with the US FDA related to vector production and certification. The site serves as the lentiviral production site for the NIH/NHLBI Gene Therapy Resources Program and has expertise in large-scale production and certification methods. Erol was also responsible as the site of the NIH National Gene Vector Biorepository and have a variety of state-of-the-art services and reagents for gene therapy. In his role as the Quality Compliance Specialist, Erol was intimately involved with the implementation of novel production and certification methods. Erol worked on a team that sought to meet the regulatory challenges in this developing field.
Erol also has experience with a wide variety of FDA regulated products such as medical devices, in vitro diagnostic reagents and instruments, in vivo diagnostics, pharmaceuticals, combination products, nuclear medicine, biologicals, and of course gene therapy. As an engineer, quality professional, and entrepreneur, Erol has developed a reputation for custom designing complete and seamless approaches to client challenges that incorporate both technical and business considerations.
He is a Certified Biomedical Auditor (CBA) and trained as ISO Lead Auditor. Erol’s BSME from Purdue is complemented by his Political Science degree from Indiana University helping him understand the regulatory process and language; his work toward an MBA provides business insight. He is a member of ASQ – American Society for Quality, ASQ Biomedical Division Midwest Discussion Group, ASGCT – American Society of Gene and Cell Therapy, AABM - Association of Academic Biologics Manufactures, ASME – American Society of Mechanical Engineers and SAE – Society of Automotive Engineers.