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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