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.
Managing Toxic Employees: Strategies For Leaders To Effecti…
DOL Reverses Course on Independent Contractor Rule for 2026…
The emergence of Social Determinants of Healthcare
Leadership: Strategic Planning and Decision Making
Beginners Guide to Data Transformations in Power Query
Understanding EBITDA – Definition, Formula & Calculation
Navigating HR Like A Pro: What Every Small Business & New H…
HPLC Analytical Method Development and Validation
ChatGPT and Project Management: Leveraging AI for Project M…
Managing Projects When AI Joins the Team: Human Judgment, A…
Negotiating Skills For Professional Results - Winning Strat…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Paying and Receiving Payments for Referrals: You Can Go to …
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
Tattoos, hijabs, piercings, and pink hair: The challenges …
The Importance of the first 5 seconds when presenting
Ten Red Flags that Signal Financial Distress in Business Cu…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
The New W4 - How to Assist Employees with Proper Completion…
Transforming Anger And Conflict Into Collaborative Problem …
Microsoft Excel PivotTables: Basics of Data Analysis for Bu…
4-Hour Virtual Seminar on Management Skills For New Managers
Fatal Errors Employers Make When Updating Employee Handbook…
Tools for New Managers: Connecting with Employees to Optimi…
Supervisor Excellence: Skills to Lead High-Performing Teams
The Manager’s Playbook for Leading After Layoffs: Quickly R…
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
Launch Your Career: The Ultimate Guide for Emerging Profess…
Mastering Performance Management: Strategies for Continuous…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Pivot tables beginner to advanced + 20 advanced Pivot table…
AI Fundamentals for All Leaders and Managers: How to Work S…
Rewiring Your Emotional Triggers: Leading with Clarity and …
The $1M Mistake: EEOC Discrimination Claims Employers Make …
Using Claude in Excel for Productivity, Automation & Data A…
AI in B2B Marketing: What Your Compliance Team Needs to Know