ComplianceOnline

Expert Profile


Angela Bazigos
CEO, Touchstone Technologies Inc

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include:

  • Chief Compliance Officer, http://morflearning.com/angelabazigos/.
  • QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA.
  • Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx.
  • Patent on speeding up software compliance https://www.google.com/patents/US8266578.
  • Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/.
  • Comments / collaborates with FDA on new guidance documents.
  • Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

Trainings by Expert

Writing Effective and compliant SOPs
Category: All FDA Regulated Industry , Documentation and IT , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences

21 CFR 11 Compliance for Excel Spreadsheet
Category: All FDA Regulated Industry , FDA Validation , FDA 21 CFR Part 11 , Documentation and IT , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations

Responding to FDA 483s and FDA Warning Letters - Best Practices
Category: All FDA Regulated Industry , FDA Audit and Inspection , Audit & Inspection-Role , All FDA Reg. based Audit , Life Sciences

Project Management for Computer Systems Validation
Category: All FDA Regulated Industry , Documentation and IT , Best Practices & GXPs , Life Sciences

FDA Guidance: Medical Device Recalls
Category: Medical Devices , Marketing and Promotion , Supply Chain and Manufacturing , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , FDA Validation , FDA 21 CFR Part 11 , Documentation and IT , Laboratory , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , IT Security

Current Concepts and Challenges in Cloud Compliance
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , FDA Validation , FDA 21 CFR Part 11 , Documentation and IT , Laboratory , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , All FDA Regulated Industry , FDA Audit and Inspection , GXP Pharmaceutical , GXP Medical Devices , Documentation and IT , Quality and Safety , Audits & Inspections , R & D , Quality & Safety , Drugs Regulations , Biotech Regulations , Risk Management & Controls , All FDA Regulated Functions , Audit & Inspection-Role , All FDA Reg. based Audit , Medical Device Inspection , Drugs Inspections , Life sciences QA/QC , Research & Development , Drug R & D , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , FDA Validation , Testing and Validation , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Laboratory , Quality & Safety , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

3.5 hr Virtual Boot Camp: How to Survive an FDA Food Facility Inspection
Category: All FDA Regulated Industry , Food Safety Compliance , Audits & Inspections , Food & Dietary Supplements , Manufacturing & Contamination control , Audit & Inspection-Role , Food Safety Audit , Food Safety & Quality , Regulatory Affairs , QA/QC