ComplianceOnline

Expert Profile


Henry Urbach
Principal, GMP TDC LLC

Henry Urbach, is the founder of GMP Training, Development and Consulting, GMP TDC LLC, a New York-based consulting organization serving Life Sciences industries. He has 20+ years of Life Sciences experience having held positions of increased responsibility in GMP Training and QC Microbiology. His experience includes managing and implementing CGMP compliance and quality systems training, for major pharmaceutical and biotechnology organizations. He is a dynamic speaker specializing in FDA and ICH compliance. He is a Certified Quality Auditor. His technical education is further complemented by his BA degree in Biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP TEA, a national organization of Life Sciences training professionals.

Trainings by Expert

Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Category: Drugs and Chemicals (Pharma) , Biotechnology , GXP Pharmaceutical , Testing and Validation , Quality and Safety , Laboratory , Contamination Control , Microbiology Laboratory , Quality & Safety , Life sciences QA/QC , Life Sciences , QA/QC

Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , Food Safety Compliance , GXP Pharmaceutical , GXP Medical Devices , Testing and Validation , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Contamination Control , Quality & Safety , Food & Dietary Supplements , Manufacturing & Contamination control , Life sciences QA/QC , Life Sciences , ISO 22000 , QA/QC

You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , Testing and Validation , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Laboratory , Contamination Control , GLP & Other Best practices , Quality & Safety , Technologies and Processes , Food & Dietary Supplements , Drugs Regulations , Biotech Regulations , Food Safety & Quality , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Creating Effective SOPs for Regulatory Compliance
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , Documentation and IT , Quality and Safety , Audits & Inspections , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Laboratory , GLP & Other Best practices , GCP & Other Best Practices , Trial Design and Management , Quality & Safety , Food & Dietary Supplements , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Food Safety & Quality , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , Testing and Validation , Quality and Safety , Audits & Inspections , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Laboratory , Contamination Control , Microbiology Laboratory , Drug Development , Quality & Safety , Technologies and Processes , Food & Dietary Supplements , Manufacturing & Contamination control , Drugs Regulations , Biotech Regulations , Audit & Inspection-Role , Quality Audit , Food Safety Audit , All FDA Reg. based Audit , Medical Device Inspection , Lab Audit , Drugs Inspections , Food Safety & Quality , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Creating FDA-compliant cGMP Training Program
Category: Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , HR Compliance , All FDA Regulated Industry , All FDA Regulated Industry , FDA Audit and Inspection , FDA Validation , Testing and Validation , Quality and Safety , Audits & Inspections , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Laboratory , Quality & Safety , Food & Dietary Supplements , Manufacturing & Contamination control , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Audit & Inspection-Role , All FDA Reg. based Audit , Medical Device Inspection , Lab Audit , Drugs Inspections , Clinical Research Audit , Food Safety & Quality , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC , Training

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing
Category: Drugs and Chemicals (Pharma) , Biotechnology , Quality and Safety , Supply Chain and Manufacturing , Contamination Control , Cosmetics , Quality & Safety , Technologies and Processes , Blood and Blood Products , Tissue and Tissue Products , Cellular and Gene Therapy , Biologics and Biosimilars , Life sciences QA/QC , Life Sciences , QA/QC

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production
Category: Drugs and Chemicals (Pharma) , Biotechnology , GXP Pharmaceutical , Testing and Validation , Quality and Safety , Laboratory , Contamination Control , GLP & Other Best practices , Microbiology Laboratory , Quality & Safety , Technologies and Processes , Blood and Blood Products , Tissue and Tissue Products , Cellular and Gene Therapy , Biologics and Biosimilars , Life sciences QA/QC , Research & Development , Drug R & D , Regulations & Guidances , Life Sciences , QA/QC

GMP Training Practices to ensure Regulatory Compliance
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , Documentation and IT , Laboratory , Drugs Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC