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.
Secrets Of The Staffing Fix - Solving The Employee Training…
Mastering the Prompt: How Every Professional Can Use AI to …
Using Copilot to Format Legal Documents in Microsoft Word
Setting SMART Goals & Leveraging Storytelling for Reporting
Eliminate Harmful And Unproductive Drama In The Workplace
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Discover how Emotional Intelligence turns AI from a technic…
Introduction to Microsoft Power BI Dashboards
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Major cGMP Issues: FDA Concerns in 2026
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
2-Hour Virtual Seminar on In-Person Onboarding Your New Hir…
6-Hour Virtual Boot Camp on Microsoft Power BI
HR Auditing - New Update on Important Issues for 2026
Managers/Supervisors: New Role, Same Team - How to Lead Wit…
Managing Toxic Employees: Strategies For Leaders To Effecti…
California Meal and Rest Breaks: What You Don't Know Can Co…
Female to Female Hostility @Workplace: All you Need to Know
Launch Your Career: The Ultimate Guide for Emerging Profess…
Project Management for administrative professionals
Creating Employee Handbooks that Protect You and Support th…
Tools for New Managers: Connecting with Employees to Optimi…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Managing Difficult Employee Conversations
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Copilot and HR: An Introduction for HR Professionals
I-9 Audits: Strengthening Your Immigration Compliance Strat…
ChatGPT and Project Management: Leveraging AI for Project M…
Practice Safe Stress ™: Preventing Burnout While Building R…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Rewiring Your Emotional Triggers: Leading with Clarity and …
AI, Jobs, and Skills: How HR Leaders Can Prepare Now for th…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Pivot tables beginner to advanced + 20 advanced Pivot table…