The US Food and Drug Administration (FDA) has detailed regulations for pharmaceutical Good Manufacturing Practice (GMP). These regulations describe in general terms the minimum requirements for preparation of over-the-counter (OTC) and prescription (Rx) drug products. These regulations are divided into 11 major subparts, each of which has various subparts. All employees of pharmaceutical manufacturing firms are required to be trained in and to know the GMP regulations that are relevant to their job functions.
Loren Gelber
Dr. Loren Gelber is currently an independent consultant, based in Charlotte, NC.She previously was employed by Akesis, Bestsweet, RRI, Andrx, Royce, Universal Research, Danbury Pharmacal, Barr and the US FDA. She has been in Regulatory Compliance, Regulatory Affairs, Clinical Research and Quality Control Laboratories.Dr. Gelber has a Ph.D. in Medicinal Chemistry from Northeastern University, a Masters in Chemistry from Brooklyn Polytechnic and a Bachelors in Biology from Brandeis University.
The Importance of the first 5 seconds when presenting
Project Management for administrative professionals
How to Reduce Human Error in a GMP Manufacturing Floor
Trump’s Executive Orders on DEI and Disparate Impact, and t…
How Accountants Can Use Chat GPT Effectively
The OBBBA Era & Beyond: Your 2025 Playbook for Compliance a…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Changing Behavior: Why Rewards and Punishments Often Aren't…
Launch Your Career: The Ultimate Guide for Emerging Profess…
ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT
Managing Toxic & Other Employees Who Have Attitude Issues
Data Integrity – In compliance with CSA, 21 CFR Part 11, Sa…
Effectively Handle Toxic People for Better Productivity and…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Employee Handbooks: 2025 Critical Issues
Better Business Writing-How to Write Right
The five qualities every successful leader must develop
How to Lead and Manage a Narcissistic Employee
Use of AI and GPT for Finance Professionals
ChatGPT and Project Management: Leveraging AI for Project M…
Analytical Method Validation Under Good Laboratory Practic…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Excel What-If-Analysis Decision-Making Tools
How to Write Contracts for Procurement Professionals
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Dealing With Difficult People: At Work & In Life
Excel - Reporting Simplified - Learn Pivot Tables from Scra…
Retention Starts Here: Stop Losing Your Critical Talent and…
Turning Workplace Conflict into Positive Connection
Project Management for Non-Project Managers - How to commun…
The Business Case for LGBTQIA+ Inclusion in the Workplace: …
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
AI-Powered Change Leadership Operationalizing AI: Practical…
AI and Human Resources: The Great Opportunity!
Cyber Security Incident Response Team Training Program
Transforming Anger And Conflict Into Collaborative Problem …
The Courage to Speak: Overcoming Fear and Owning the Room
Finance & Accounting 101 Simplified
6-Hour Virtual Boot Camp on Microsoft Power BI