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.
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
New EEOC Report: Workplace Harassment Prevention Not Workin…
Human Error Reduction Techniques for Floor Supervisors
21 CFR Part 11 - Compliance for Electronic Records and Sign…
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Transforming Change and Conflict into Diverse-Inclusive-Col…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Navigating 2025 Employment Laws: What Every Employer Needs …
Managing Difficult Employee Conversations
ChatGPT and Project Management: Leveraging AI for Project M…
Future Of Forecasting And Budgeting With Rolling Forecast
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Internal Controls in Accounts Payable
The FMLA - An Employer's Guide to Compliance and Employee A…
Excel Power Skills: Master Functions, Formulas, and Macros …
Develop People Intelligence: Is Your Communication Style as…
The Impact of Artificial Intelligence on Your Workforce
AI in Everyday Work – help with Microsoft products
How to Document Employee Discussions and Why it is Important
Construction Lending And Real Credit Administration: Evalua…
The Anti-Kickback Statute: Enforcement and Recent Updates
Navigating FDA Inspections: From SOP to 483
2025 EEOC & Employers: Investigating Claims of Harassment …
2-Hour Virtual Seminar on DeepSeek R1 for Business and Mark…
Risk Analysis in the Medical Device Design Process
Introduction to Microsoft Power BI Dashboards
How To Get Control of Your Day, Life & Career - Time Manage…
AI Across the Business: Practical Use Cases for Founders an…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Female to Female Hostility @Workplace: All you Need to Know
Writing Effective 483 and Warning Letter Responses
FDA Recommendations for Artificial Intelligence/Machine Lea…
Language is Code - Intro to AI - Generative AI - ChatGPT an…
Understanding EBITDA – Definition, Formula & Calculation