All about Quality and Compliance
Equal Employment Opportunity requirements It’s all about INCLUSIONAnyone QUALIFIED should have access to the candidate pool. Unqualified do not need to be considered Use of a NON-DISCRIMINATORY SELECTION PROCESS to compare and determine applicants chosen for placement Affirmative Action requirements It’s all about ASSIMILATION ASSURE minority and female REPRESENTATION in all candidate pools Follow EEO Read more about EEO vs AA[…]
Interns are viewed as employees unless below all six conditions apply The internship, generally include actual operations in the office of the employer, but is similar to educational training that would have got in the school environment. The intern is not necessarily entitled to a job at the conclusion of the internship The work they Read more about How to segregate Interns vs employees[…]
CTD Triangle showing 5 modules in pictoral form as shown below infographic
The various methods of allergen labelling are as follows : All retail products must have Allergens labelled. Restaurant employees must be able to control and discuss allergen presence with customers. Common names must be used The allergen may appear in bold following the ingredient containing the allergen, on the label The allergen and Contains statement Read more about Allergen Labeling[…]
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[…]