Quality Management and Compliance in the Life Science Industries

01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Erol Ali Cetinok has over twenty five years of experience in various engineering, compliance, validation and quality roles.He is a Certified Biomedical Auditor (CBA), and trained as a ISO Lead Auditor"

A good Quality Management System (QMS) would add greatly to the success of any organization

Description

Life Sciences industries include Pharmaceutical, Medical Device, Biologics, Gene Therapies, and individualized medical treatment organizations. Topic includes a brief review of aspects of Quality Management Systems (QMS), Food and Drug Administration (FDA)/Good ‘x’ Practices (GxPs), and ISO and how they can be integrated into a successful Life Science organization. The principles for all Life Science organizations are very similar but possess some unique differences due to the nature of the products. This topic is a broad overview of these elements and why they could be implemented.

Why should attend

Quality management and regulatory compliance have a unique relationship. This relationship is not always known or implemented correctly. One of the important things to remember is that regulatory compliance is required by law, whereas quality is not. This sometimes confuse the issues facing the Life Science industry as well. The FDA is mandated by law and has some unique requirements for the Life Science community. At the same time, ISO (either 9000, 13485, or any other) provides great guidance to the Life Sciences beyond regulation and/or quality. Lastly a good Quality Management System (QMS) would add greatly to the success of any organization in the Life sciences industry. Any organization that is willing to smoothly and accurately integrate these elements will see benefits throughout the organization beyond just quality and compliance.

This program would be very beneficial to a start-up in the Life Sciences industry as it is an overview as to what to expect. Along those lines, novel Life Sciences, such as Gene Therapy, Precision and/or individualized medicines would also benefit due to their unique requirements and needs.

Areas Covered

•        Description of various Life Science organizations and the unique needs of them.
•        Description of GxPs and briefly how they fit into the Life Sciences.
•        Brief discussion of 21CFR210 and 21CFR820.
•        Brief discussion of ISO standards (focusing on 9000 and 13485)
•        Some elements of QMS practices in Life Sciences
•        Relationship between these elements in the Life Sciences
•        Some unique elements of each of these elements to the Life Science industry

Session Highlights

•        Requirements for Regulatory needs of Life Science companies will be covered
•        Requirements for Standard needs of Life Science companies will be covered
•        Requirements for Quality needs of Life Science companies will be covered
•        How these elements interact with each other and its effects on Life
•        Discussion of unique needs of Life Sciences and how Life Sciences can learn from other industries
•        Why are these elements needed in Life Sciences and how to start their relationships with the organization
•        Terms ‘Quality’ and ‘Regulatory’ will be placed into perspective
•        Why NOT to fear any of these elements

Who will Benefit

•        Leadership of Start-ups
•        Higher Management of Life Science
•        Regulatory Management
•        Quality Assurance Management
•        Engineering Management
•        Financial Management
•        Entry level, mid-level personnel of Life Science Company needed overview of topic

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

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 experiences 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 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 serve as the lentiviral production site for the NIH/NHLBI Gene Therapy Resources Program and have expertise in large-scale production and certification methods. Eroll 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

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