Stability and Shelf Life of Medical Devices

Why Should You Attend:

New or modified devices must show no decline in performance affecting device safety and effectiveness over time, determining shelf-life (expiration date) prior to release to market. Since most polymers follow zero, first order Arrhenius behavior, samples of real-time aged product normally provide validation of the use of samples that have undergone accelerated aging. Testing to show that there is no decrease in device performance that may affect device safety or efficacy over time is gathered during testing of the accelerated-aging group and the results are normally validated when compared to the required testing of samples aged in “real-time”. However, the products are allowed to proceed to market based on shelf-life determination using accelerated aged products.

Samples used in both the accelerated and real-time groups should represent normal product and processing, including undergoing sterilization of product in their primary packaging. Packaging integrity/maintenance of sterility should be established as well. Understanding product characteristics critical for device safety and efficacy, user requirements (hospital use vs. military use and environmental extremes/physical stress) may increase understanding of device development, transfer from R&D to manufacturing and improve detection of quality or process issues.

Areas Covered in the Webinar:

• CFR requirements, FDA, ISO, ASTM, European guidelines/standards that are applicable to the requirement for determination of shelf-life and stability for medical devices.
• Requirements and specific criteria necessary to design studies done on product that is aged using both real-time and accelerated aging conditions, parameters for establishing stability of the device and device packaging.
• Criteria used for assessing the stability of a specific device and all other relevant criteria to be included in the design of the stability protocol for the medical device/product packaging will be discussed.
• The data required for the initial release of a product to the market and the manner in which this initial expiration date may be extended will be discussed.
• The Design Control process and its’ importance to ensuring that the product is stable and adequate for its’ intended use over the shelf-life of the product.
• ISO 13485:2003 will be compared to the version of ISO 13485 that was revised in 2016 and will be implemented in 2019.

Who Will Benefit:

• Quality personnel
• Validation personnel
• Engineers or others involved in device design or in the design control process
• Design control personnel
• Packaging engineers
• Stability testing personnel
• Compliance personnel
• Distributing/Shipping personnel
• Personnel responsible for process/product design
• Manufacturing personnel

Stephanie Cooke
Consultant, Cooke Consulting, Inc

Stephanie Cooke is the President/CEO of Cooke Consulting, Inc., using her 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biopharmaceutical, medical device and nutraceutical firms. Her broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical and biotech products, drug/device combination products and medical devices in all stages of development (INDs, NDAs, post-marketing, orphan drug submissions, 510ks, PMAs and HDEs). She also has extensive QA and validation experience, hosting many compliance audits conducted by FDA, ISO and other international regulatory bodies, conduct/management of auditing program to qualify contract manufacturers and vendors of raw materials, APIs, product release experience in manufacturing environments and for companies using contract manufacturers, responsibility for QMS for all product types (CAPA, Complaint, Document Control systems), stability programs, as well as preparation/performance of manufacturing process validation, sterilization validation (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems and qualification of equipment.

Stephanie worked for Scīele Pharma from 2005-2009 and was VP of Regulatory Affairs, Quality Assurance/Validation for Scīele, leaving in 2009 to start Cooke Consulting. She also held various senior RA, QA and validation positions at Merial, Bayer, Cryolife, Theragenics and other pharmaceutical, biotech and device companies, after beginning in industry as a lab tech and as a certified as a Microbiologist. She has a BS in Biology and an M.S. in Molecular Genetics and Biochemistry.

Follow us :