Dr. Loren Gelber

Area Of Expertise : Pharmaceutical
40 Years Of Experience
Training Industry : Life Sciences

Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.

9 results Found
Live Webinar

How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

This webinar will include things that it is important to know about FDA inspections. Using the self-auditing process to correct problems before the FDA or customer arrives will be discussed. How to prepare for an FDA inspection and how to b ...

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Oct 08, 2019
On-Demand Webinar

Cannabinoids As Drugs – Latest Updates

This webinar will discuss the current status of cannabinoids as medical products in the United States. The focus will be on what we can learn from the FDA approval of Epidolex (Cannabidiol) oral solution 100 mg/mL. How to obtain research in ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded Webinar

Equipment Qualification and Process Validation

FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated i ...

  • Intermediate
  • 90 Mins
On-Demand Webinar

Cannabinoids as Drugs

This webinar will discuss the current status of cannabinoids as medical products in the United States. The focus will be on what we can learn from the FDA approval of Epidolex (Cannabidiol) oral solution 100 mg/mL. How to obtain research in ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded Webinar

FDA Rules for Pharmaceutical Analytical Method Validation

FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the ...

  • Intermediate
  • 60 Mins
Recorded Webinar

FDA Regulations for Pharmaceutical Current Good Manufacturing Practice (cGMP)

This webinar will review all the sections of FDA cGMP regulations. Regulation text and examples from the instructor’s experience will be presented. Warning Letters and Inspectional Observations will be used as examples of what not to do. ...

  • Basic
  • 90 Mins
Recorded Webinar

FDA Regulation of Over-the-Counter (OTC) Drugs

Definitions of prescription (Rx) and OTC drugs will be presented. The three ways that FDA regulates OTC drugs, Monographs, Applications and Rx to OTC switches, will be discussed. Labeling rules for OTC products will be reviewed. Other requi ...

  • Basic
  • 60 Mins
Recorded Webinar

Equipment Qualification and Process Validation

FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated i ...

  • Intermediate
  • 90 Mins
Recorded Webinar

Equipment Qualification and Process Validation

FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated i ...

  • Intermediate
  • 90 Mins