The FDA’s QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. QSR allocated the information into four documents. The Design History File (DHF) gives a history of device design. One of the design outputs is the Device Master Record (DMR). The Device Master Record (DMR) Read more about Records FDA inspectors look for – related to Quality system[…]
There are various regulations formulated by different agencies highlight as a whole or part the supplier qualification guidelines. few are below. ISO 13485 Clause 4.6.2: Assessment of Sub-contractors–ISO 13485:2003 – Clause 7.4.1 mimics previous clause; standard adds explicit reference to “outsourced process” (4.1) – Clause 7.4.1 – The type and extent of control applied to Read more about Supplier Qualification Regulations[…]
1977 Congress passes FCPA act to stop bribery and restore public confidence in U.S. business systems.it has 2 sections Anti -Bribery and accounting provision.Anti-Bribery provison is enforced by DOJ (department of justice) and it helps in Prohibiting corrupt payments (bribes) to foreign government officials, political parties, party officials and candidates in order to obtain or Read more about FCPA Act Anti-bribary provisions[…]
Your bank’s risk assessment should assist you in effectively managing the BSA/AML risk and, therefore, is critical in the development of applicable internal controls, as required for your BSA/AML compliance program Common Problems with Risk Assessments If you are aware of problems commonly found, you can more efficiently conduct risk assessments. These problems include the Read more about BSA Risk Assessment Problems[…]
There are many meetings which a sponser can have with FDA related to the product being developed and to be approved by FDA. But it can be categorized in to 3 base categories. Type A: Critical Path (Urgent) meetings – Clinical hold, Safety Issues, Site disqualification, etc (within 30 days)Type B: Procedural meetings – Pre-IND Read more about Sponser Meeting with FDA some facts[…]
There are mainly 3 categories of Process Validation conducted. 1.Prospective– Validation conducted prior to the distribution of either a new product, or product made under a revised manufacturing process, where the revisions may affect the product’s characteristics. There are three phases of prospective validation:– Installation qualification (Process equipment consistently operates within established limits and tolerances)– Read more about Types of Process validation & Steps[…]
Failure Modes and Effects Analysis is the subject of an international standard, IEC 60812-Analysis techniques for system reliability-Procedure for failure mode and effects analysis (FMEA) The only international standard that applies for FMEA is IEC 60812, which shows general application, but does not show the use of the tool in risk management.An extension to the Read more about What is FMEA and How to Use it ?[…]
Be specific, truthful, unbiased and scientific Avoid Public responses Keep private response specific to the question Make sure the persons responding on behalf of you are medical or scientific personnel Make sure sales and marketing personnel are not involved at all even in training and awareness Makes sure you are keeping record of all the Read more about Dos and Don’ts of responding to Unsoliciated offlabel requests[…]
Due to COVID-19 many employers has adopted work from home set up for their employees. But as it is not the typical employer premises i.e work environment or the big circle around work environment where we define work related cases to record, it becomes difficult to know what to do when an employee reports an Read more about OSHA Recordkeeping for Work from home cases[…]
What is Just In Time or JIT ? The just-in-time (JIT) inventory system is a management strategy that aligns raw-material orders from suppliers directly with production schedules. This is driven by management philosophy of continuous and forced problem solving by using less input to get maximum output and by decreasing the waste in resources due Read more about Just In Time (JIT) Principles[…]