Expert Profile
Angela Dunston
Principal, PharmaPact Consulting Services
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining quality management systems that are cohesive and properly interact with all areas of the organization.
During these 20 years, Ms. Dunston has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, she has worked with US FDA agents to ensure compliance for her clients.
Her international experience has assisted global organizations such as Johnson and Johnson, The Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has offered trainings on procedures from the V-suite to the manufacturing floor. Ms. Dunston works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.
Trainings by Expert
FDA Vs Health Canada
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Clinical Research
,
Biotechnology
,
Laboratory Compliance
,
All FDA Regulated Industry
,
Quality and Safety
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Laboratory
,
Quality & Safety
,
Drugs Regulations
,
Clinical Trial Regulations
,
Biotech Regulations
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
QA/QC
Process Robustness: The New FDA Paradigm
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Biotechnology
,
Laboratory Compliance
,
All FDA Regulated Industry
,
Testing and Validation
,
Quality and Safety
,
QMS, ISO 13485, CAPA
,
Laboratory
,
Microbiology Laboratory
,
Clinical Laboratory
,
Analytical Laboratory
,
Quality & Safety
,
Drugs Regulations
,
Clinical Trial Regulations
,
Biotech Regulations
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
QA/QC
FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Biotechnology
,
All FDA Regulated Industry
,
GXP Pharmaceutical
,
GXP Medical Devices
,
Testing and Validation
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Laboratory
,
GLP & Other Best practices
,
Quality & Safety
,
Biologics and Biosimilars
,
Drugs Regulations
,
Biotech Regulations
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Life sciences QA/QC
,
Research & Development
,
Drug R & D
,
Device R & D
,
Regulations & Guidances
,
Best Practices & GXPs
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry
Category:
Drugs and Chemicals (Pharma)
,
All FDA Regulated Industry
,
GXP Pharmaceutical
,
Documentation and IT
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Drugs Regulations
,
Regulations & Guidances
,
Best Practices & GXPs
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Biotechnology
,
All FDA Regulated Industry
,
FDA Audit and Inspection
,
GXP Pharmaceutical
,
GXP Medical Devices
,
FDA Validation
,
Testing and Validation
,
Quality and Safety
,
Audits & Inspections
,
Supply Chain and Manufacturing
,
R & D
,
Drug Development
,
Quality & Safety
,
Drugs Regulations
,
Biotech Regulations
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Life sciences QA/QC
,
Research & Development
,
Drug R & D
,
Device R & D
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
QA/QC
