Compliance Dictionary
Banking and Finance (19)
- What Are SOX 404 top–down risk assessment (TDRA)?
- What Is Form 1099-C: Cancellation of Debt
- What is an ISO 22301 certificate?
- What Do You Mean By Earnings Before Interest and Taxes(EBIT)
- Forensic Audit Definition, Example and Investigations
- SSARS Resources, Statement on Standards, Compilation and Review
- System and Organization Controls (SOC 1, SOC 2 & SOC 3) Reporting
- Credit Memorandum – Overview, Definition and Example
- Key Component of AML (Anti Money Laundering) Compliance Program
- The Purpose of Corporate Governance Defined
Compliance (7)
- What Do You Mean By SDTM (Study Data Tabulation Model)?
- The American Anti-Corruption Act: Stop Political Bribery
- How to be DFARS Compliant – Procedures, Guidance and Information
- Advanced Product Quality Planning (APQP)
- 2020 RoHS Compliance Guide
- OCEG’s GRC Capability Model – A Pioneering Approach Towards Integrity of Organizations
- Compliance Matrix – A Key Step in All RFP Processes
Drugs (6)
- Everything you need to know about BEDOYECTA TRI (HYDROXOCOBALAMIN, VITAMIN B1, VITAMIN B6)
- The Investigator Brochure – A Key Document in Drug Development
- SUPAC – Scale Up and Post Approval Changes
- FDA Guidance for Drugs: Bracketing and Matrixing
- What is Post Market Surveillance for Drugs?
- Analytical Procedures and Methods Validation for Drugs
FDA (10)
- What is an Investigational New Drug Application for FDA?
- FDA Audit Program – What You Need To Know
- Medical Device Single Audit Program (MDSAP)
- FDA E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
- Fair Packaging and Labeling Act (FPLA) – FDA 16 CFR Part 500
- FDA Form 483 – Inspectional Observations and Citation
- How the FDA Drugs Development & Approval Process Works
- Current Good Manufacturing Practice (cGMP) and How to Use Them
- The Ultimate Primer on FDA 21 CFR
- Investigational Device Exemption (IDE) in Medical Devices
Human Resources (10)
- Are You Getting Your Meal Breaks?- California Labour Act
- All You Need to Know About California Family Rights Act (CFRA)
- California Family Rights Act – CFRA/FMLA and Parental Leave
- Compensation (Compa) Ratio – Definition, Formula & How to Calculate
- Older Workers Benefit Protection Act (OWBPA)
- State Disability Insurance (SDI) Program California 2020 – Tax, Rates and Limit
- What Are Fringe Benefits & How Do They Work?
- Dysfunctional Conflict in Organizations – How to Identify and Resolve it Quickly
- Know Your Rights and Responsibilities: CFRA/FMLA Leaves
- Guidance for Employers Conducting Form I-9 Audits
Medical Device (15)
- What Are In Vitro Diagnostic Tests, and How Are They Regulated?
- Biological Evaluation of Medical Devices – ISO 10993
- WHAT IS A GUDID AKA Global Unique Device Identification Database
- IEC 60601 – Medical Design Standards For Power Supplies
- E/M Codes – Evaluation and Management Coding Documentation Guidelines
- Overview and The 3 Stages of Process Validation
- FDA Guidance on IEC 62304 Software Standard
- Use of ISO 10993: Biological Evaluation of Medical Devices
- Overview of Medical Device Design History File (DHF)
- ISO 14971: Application of Risk Management to Medical Devices
Trade (6)
- An Overview of the Export Administration Regulations
- Determining and Understanding Responsibilities of the U.S. Principal Party in Interest (USPPI)
- Import Trade Auxiliary Communication System (ITACS) – FDA
- Export Control Classification Number (ECCN)
- USPPI – How To Identify This Key Entity in Export Transactions
- LIFO Liquidation – Best Practices to Solve