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.
Empowering Conflict Resolution: Letting Go to Gain Control
Developing an Agile Workforce with Emotional Intelligence (…
FDA Regulation of Artificial Intelligence/ Machine Learning
Compliance Under Fire: Navigating I9 Immigration Raids & …
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
Human Error Reduction Techniques for Floor Supervisors
How To Conduct An Internal Harassment And Bullying Investig…
Secrets Of Psychology - Why People Do The Things They Do
FDA Compliance And Laboratory Computer System Validation
Leadership: Strategic Planning and Decision Making
Polish your Presence on Linkedin - The Powerful Profile
Marketing to Medicare or Medicaid Beneficiaries - What You …
Human Factors Usability Studies Following ISO 62366 and FDA…
Leveraging Artificial Intelligence in HR
Bootcamp for New Managers and Supervisors: Develop These Es…
Utilizing A Proven Process When Conducting Sensitive, Inter…
Understand the Different Contexts in DAX, The Filter Contex…
Understanding and Analyzing Financial Statements
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
The Importance of Storytelling in Project Management
Defensive Documentation: Protecting Your Organization from …
Topic Name/Course Title Leading a Project and Team in Stres…
Power Bi - Turn Bad Data Into Great Data In Minutes
OSHA Reporting: What are OSHA's Reporting Requirements?
Onboarding is NOT Orientation - How to Improve the New Empl…
Copilot and HR: An Introduction for HR Professionals
Establishing Appropriate Quality Metrics and Key Performanc…
How to Write Effective Audit Observations: The Principles f…
Basic Accounting and Finance for Human Resources Profession…
EBIT/EBITDA - Understanding Your Profit and Loss Statement-…
FDA Audit Best Practices - Do's and Don'ts
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
FDA Technology Modernization Action Plan (TMAP) and Impact …
Stress, Change And Team Resilience Through Humor: An Intera…
Controller Challenges in Changing Times: New Roles as Strat…
The Importance of the first 5 seconds when presenting
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Sunshine Act Reporting - Clarification for Clinical Research
How to Prepare For and Host a FDA Inspection and Respond to…
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Managing Toxic Employees: Strategies For Leaders To Effecti…