Expert Profile
Kelly Thomas
Head Of Quality Assurance, Veru Inc
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
Trainings by Expert
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
Category:
Drugs and Chemicals (Pharma)
,
Quality and Safety
,
Life Sciences
Annual Current Good Manufacturing Practices (cGMP) Training
Category:
Drugs and Chemicals (Pharma)
,
Clinical Research
,
Biotechnology
,
All FDA Regulated Industry
,
GXP Pharmaceutical
,
Documentation and IT
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Drug Development
,
Quality & Safety
,
Drugs Regulations
,
Biotech Regulations
,
Life sciences QA/QC
,
Research & Development
,
Drug R & D
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
Implementing a Robust and Compliant Change Control Program
Category:
All FDA Regulated Industry
ASTM 2500: Lessons Learned Through a Decade of Implementation
Category:
Drugs and Chemicals (Pharma)
,
All FDA Regulated Industry
,
Risk Management & Controls
,
Audit & Inspection-Role
,
Documentation and Policy Management
,
Research & Development
,
Life Sciences
,
Regulatory Affairs
,
QA/QC
How to Write Effective 483 and Warning Letter Responses
Category:
All FDA Regulated Industry
Implementing a Quality Management System
Category:
Laboratory Compliance
Establishing a Robust Supplier Management Program
Category:
All FDA Regulated Industry
FDA Internal Complaint Handling
Category:
Drugs and Chemicals (Pharma)
USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure
Category:
All FDA Regulated Industry
Implementing a Robust Data Integrity Program
Category:
All FDA Regulated Industry
