There are three primary set of export and sanctions rules. These are: · U.S. Export Administration Regulations (EAR) · International Traffic in Arms Regulations (ITAR) · Economic Sanctions Regulations U.S. Export Administration Regulations Export Administration Regulations (EAR) are found in 15 CFR Parts 730 to 744. These are administered under International Economic Emergency Powers Act by the Commerce Read more about U.S. Export/Sanctions Laws[…]
HFE is a scientific discipline concerned with the understanding of interactions among human and other elements of a system it is Also called: •Usability engineering •Customer-centric design •User-centered design – A series of FDA standards and guidelines intended to ensure: -“Each manufacturer shall establish and maintain procedures to ensure that the design requirement related to Read more about Human Factors Engineering – Medical Device[…]
FDA’s definition of USE error though the word USE error is not used officially. “Act or omission of an act that results in a different outcome than intended by the manufacturer or expected by the USER, which may result from a mismatch situation between USER, man-machine interface, task and/or environment.” AAMI HE74:2001 Many research suggests Read more about USE error and medical device recall[…]
Scope of this guidance Computerized systems that contain data that support a marketing application –Case histories –Analytical test results (e.g., LIMS) –Data captured from analytical instruments –Electronic transcription of hardcopy source data it Does not apply to: –Computerized medical devices Study Protocols •Identify computerized system use within the trial process •Computerized systems must: –Satisfy process Read more about FDA Guidance on Computerized Systems Used in Clinical Investigations[…]
1 -Per Article 2, Audit is defined as “an investigation conducted by a sponsor or postmarketing sponsor, or one that a sponsor-investigator appoints a designated personto determine whether the clinical trial or postmarketing clinical trial is conducted according to this Ministerial Ordinance (No. 36) and the protocol or postmarketing protocolto ensure the reliability of the Read more about JGCP Audit Requirements[…]
An OOS result is generated when a drug product undergoing release testing or stability testing fails to meet an expected result or specification. When this happens, the FDA requires a valid reason must be determined to invalidate the OOS result and therefore an investigation into the cause of the OOS result must be conducted. OOS Read more about What is OOS and how to avoid it ?[…]
Best Practice #1: Push Quality Upstream• Deploy a web-based system and make it available to outsourcedmanufacturers• They collect quality data and enter real-time into the quality system• Quality data is instantly available to OEM quality engineers• Process metrics are calculated by the system and pushed to qualityengineers every few hours• Benefit: Engineers spend more time Read more about Best practices in supplier Quality[…]
EO Concentration Commonly 400 and 700 mg/l As EO concentration increases at a given temp and RH, –microbial inactivation (kill) rate increases Killing concentration required at the site where the microbes (BI’s) are located Water Vapor (Humidity) Required for EO to react with the critical cell molecules • Generally measured as Relative Humidity Temperature Kill Read more about Four Basic Factors to Microbial Kill[…]
Individually identifiable information collected ormaintained by a Covered Entity – Can be oral or written – Can be in any medium (electronic, printed, recorded) – Includes simple demographic data – just the fact that someone is your patient/plan member is PHI – It’s still PHI if someone could reasonably figure out who the individual subject Read more about What is Protected Health Information (PHI)?[…]
There are many steps in each recall where multiple teams are involved and hence it is very important that each team exactly knows what to do and when to do. Here is a snap shot of all teams involved and at what stpe what need to be done. Notification of a recall Sales and Quality Read more about Food Recall – Each Teams responsibility[…]