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[…]
Q – Is it mandatory to have system requirements should be high level and functional specifications be detailed ? Ans – There is no specifically defined procedure for validation. Different process and terminologies comes under validation. Instead of using different terms like functional requirements, user requirements, functional specs, user specs, design specs, configuration specs, IT Read more about Expert Q&A – in computer system validation[…]