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
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.
• 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
• 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.