2021-04-01 02:26
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What is the FDA drug approval process?
FDA Drug-Approval Process. A pharmaceutical company seeking F… Read More
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Compliance Terms | Terminology | Definition of Regulatory Terms | FDA Guidance Explained
2021-03-31 02:12
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What is Endotoxin Testing?
LAL (Limulus amebocyte lysate) endotoxin testing is an in-vitro assay us… Read More
2021-03-30 01:50
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What is the purpose of good documentation practices?
Examples of the functions of documentation inc… Read More
2021-03-27 01:37
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WHAT IS A PTAN NUMBER?
Because Medicare is such an expansive system susceptible to fraud, it’… Read More
2021-03-26 01:25
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How does an RMA work?
A Return Merchandise Authorization (RMA) is used when a customer wants to ret… Read More
2021-03-25 01:11
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What is ISO 13485?
ISO 13485 Medical devices, Quality management systems, Requirements for regulato… Read More
2021-03-24 01:01
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What is cGMP certification?
CGMP refers to the Current Good Manufacturing Practice regulations enfo… Read More
2021-03-23 00:43
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Can an employee waive his or her right to overtime compensation?
No, California law requires that an… Read More
2021-03-20 00:35
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What is the role of OECD?
The main purpose of the OECD is to improve the global economy and promote… Read More
2021-03-19 00:15
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What is meant by ICH guidelines?
ICH Guidelines were created by The International Council for Harmon… Read More
2021-03-18 01:08
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What is Hipaa and what is its purpose?
The Health Insurance Portability and Accountability Act of 19… Read More
2021-03-17 00:39
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What is clinical data management?
Clinical data management (CDM) is a critical process in clini… Read More
2021-03-15 22:20
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What does GMP mean?
Good manufacturing practice (GMP) is a system for ensuring that products ar… Read More
2021-03-15 20:26
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What is The HIPAA Privacy Rule?
The HIPAA Privacy Rule establishes national standards to protec… Read More
2021-03-11 12:51
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What are cyber currency or Cryptocurrency?
A cryptocurrency is a digital or virtual currency tha… Read More
2021-03-10 10:39
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What do you mean by Hazard Analysis Critical Control Point (HACCP)?
HACCP is a management system… Read More
2021-03-09 19:09
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Does California have overtime after 8 hours or 40 hours?
In California, overtime must be paid to… Read More
2021-03-08 15:28
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Why is it required to file 1099-C?
A 1099-C reports Cancellation of Debt Income (CODI) to the IRS. A… Read More
2021-03-08 14:16
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What Is a 1099-C?
A 1099-C reports Cancellation of Debt Income (CODI) to the IRS. According to t… Read More
2021-02-23 21:28
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What is BSA and AML compliance?
Congress passed the Bank Secrecy Act (BSA), also known as the An… Read More
2021-02-22 19:38
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What is an IND FDA?
An Investigational New Drug Application (IND) is a request for Food and Drug… Read More
2021-02-17 18:28
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Why is Sdtm needed?
Why is SDTM required? SDTM is there to give regulatory reviewers – namely t… Read More
2021-02-16 21:31
The post What Are SOX 404 top–down risk assessment (TDRA)? appeared first on Read More
2021-02-12 20:40
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What Is Form 1099-C: Cancellation of Debt?
Form 1099-C (entitled Cancellation of Debt) is one of… Read More
2021-02-11 22:33
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What is an ISO 22301 certificate?
ISO 22301 is the international standard for Business Continuity Man… Read More
2021-02-10 21:58
The post What Do You Mean By Earnings Before Interest and Taxes(EBIT) appeared first on Read More
2021-02-09 21:36
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Can I skip my lunch break and leave early California? Is it permissible for employees to skip their lunch or break periods in order to leave ear… Read More
2021-02-05 23:13
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What is in vitro diagnostic use?
In vitro diagnostics are tests done on samples such as blood or… Read More
2021-02-05 20:02
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What is ISO 10993?
For nearly 10 years, Technical Committee 194 of the International O… Read More
2021-01-27 19:37
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What is Occupational Safety and Health Administration (OSHA) -
OSHA is a large regulatory agen… Read More
2021-01-26 19:18
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What is a Gudid?
The Global Unique Device Identification Database (GUDID) is a database adminis… Read More
2021-01-26 04:09
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What is the OSHA Form 301?
You must use OSHA 300, 300-A, and 301 forms, or equivalent forms, for reco… Read More
2021-01-23 04:46
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What are export control regulations?
Export control regulations are federal laws that prohibit the un… Read More
2021-01-21 19:06
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How to Give Yourself a Bedoyecta Tri B12 Shot
These instructions are only regarding the Bedoyecta Tri B12… Read More
2021-01-21 11:04
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What are the FMLA and CFRA laws?
The FMLA and CFRA are federal and state leave laws that allow eligi… Read More
2021-01-19 18:33
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What is an FDA audit program (audit plan)?
An audit program, also called an audit plan, is an action… Read More
2021-01-18 19:52
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What is Investigator’s Brochure (IB)?
The Investigator’s Brochur… Read More
2020-12-09 15:11
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The USPPI is the individual or legal entity in the United States that receives the primary benefit, financial or otherwise, from an export transac… Read More
2020-11-17 15:24
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Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials… Read More
2020-11-11 14:35
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The Form 5500 Annual Report is the primary source of information about the operations, funding and investments of approximately 800,000 retirement a… Read More
2020-10-21 14:17
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The formula commonly used by compensation professionals to assess the competitiveness of an employee’s pay level involves calculating a comp… Read More
2020-03-18 15:16
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The California Family Rights Act (CFRA) authorizes eligible employees to take up a total of 12 weeks of paid or unpaid job-protected leave during… Read More
2020-03-17 15:10
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FDA uses Compliance Program Guidance Manuals (CPGM) to direct its field personnel on the conduct of inspectional and investigational activities… Read More
2020-03-16 14:03
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The American Anti-Corruption Act is model policy that sets a framework for city, state and federal laws to fix our broken political system. It fund… Read More
2020-03-11 15:20
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Z codes are a special group of codes provided in ICD-10-CM for the reporting of factors influencing health status and contact with health service… Read More
2020-03-09 14:52
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The Accounting Review Services Committee issued Statement on Standards for Accounting and Review Services SSARS 21, SSARS 22, SSARS 23 and SSARS… Read More
2020-03-02 15:11
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If your company provides services to other companies, those reporting may have an impact on your customers’ financial reporting. As a result… Read More
2020-02-27 15:09
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A forensic audit is an examination and evaluation of a firm’s or individual’s financial records to derive evidence that can be used in… Read More
2020-02-24 15:13
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The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medic… Read More
2020-02-20 15:21
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IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment, published by the International Elect… Read More
2020-02-18 14:12
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Evaluation and management coding (commonly known as E/M coding or E&M coding) is a medical coding process in support of medical billing. Prac… Read More
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