Expert Profile
Kim Huynh-Ba
Founder and Technical Director, Pharmalytik
Kim Huynh-Ba has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is currently the executive director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. In 2011-2013, she took a sabbatical from Pharmalytik to join the USP Convention as the Director of Pharmacopeial Education Department, where she was responsible for their education programs worldwide.
Ms. Huynh-Ba has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an adjunct professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.
She is a member of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 president. Ms. Huynh-Ba was recently elected as a member of the USP Council of Experts for the 2015-2020 cycle and Chair the Chemical Medicines IV Expert Committee. She is also the Chair of USP Good Documentation Practices Expert Panel and a member of USP Impurities of Drug Products Expert Panel.
Ms. Huynh-Ba has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010).
Trainings by Expert
Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to Meet ICH Requirements
Category:
Drugs and Chemicals (Pharma)
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Quality and Safety
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Supply Chain and Manufacturing
,
Life Sciences
Stability Program to Support Shipping and Distribution of Drug Products
Category:
Drugs and Chemicals (Pharma)
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Supply chain & Procurement
,
Life Sciences
To Validate or Not To Validate: A Daily Question for the Pharmaceutical Scientist
Category:
Drugs and Chemicals (Pharma)
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Life sciences QA/QC
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Research & Development
,
Drug R & D
,
Regulations & Guidances
,
Life Sciences
,
QA/QC
Establish Change Control for Pharmaceutical Stability Program
Category:
Drugs and Chemicals (Pharma)
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Drug Development
,
Drugs Regulations
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
,
Research & Development
,
Drug R & D
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
GMP Requirements for Validation and Re-Validation of Analytical Procedures
Category:
Drugs and Chemicals (Pharma)
,
Laboratory Compliance
,
Testing and Validation
,
Quality and Safety
,
Laboratory
,
GLP & Other Best practices
,
Analytical Laboratory
,
Audit & Inspection-Role
,
Lab Audit
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections
Category:
Laboratory Compliance
,
Quality and Safety
,
Audits & Inspections
,
Laboratory
,
GLP & Other Best practices
,
Microbiology Laboratory
,
Clinical Laboratory
,
Analytical Laboratory
,
Audit & Inspection-Role
,
Lab Audit
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
Key Factors to Develop an Effective CAPA System
Category:
Drugs and Chemicals (Pharma)
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Medical Devices
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Clinical Research
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Biotechnology
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Laboratory Compliance
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All FDA Regulated Industry
,
Testing and Validation
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Documentation and IT
,
Quality and Safety
,
QMS, ISO 13485, CAPA
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Supply Chain and Manufacturing
,
Laboratory
,
GLP & Other Best practices
,
GCP & Other Best Practices
,
Quality & Safety
,
Technologies and Processes
,
Food & Dietary Supplements
,
Manufacturing & Contamination control
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Food Safety & Quality
,
Life sciences QA/QC
,
Regulations & Guidances
,
Best Practices & GXPs
,
Life Sciences
,
Documentation and Data Management
,
QA/QC
Establish an Effective Change Management Process for Stability Studies
Category:
Drugs and Chemicals (Pharma)
,
Laboratory Compliance
,
Testing and Validation
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Laboratory
,
Drug Development
,
Drugs Regulations
,
Life sciences QA/QC
,
Research & Development
,
Drug R & D
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
QA/QC
Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products
Category:
Drugs and Chemicals (Pharma)
,
All FDA Regulated Industry
,
GXP Pharmaceutical
,
Drug Marketing Compliance
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Marketing and Promotion
,
Supply Chain and Manufacturing
,
Drugs Regulations
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Supply chain & Procurement
,
Life Sciences
,
Regulatory Affairs
Studies to Support Temperature Excursions and Shipping of Pharmaceutical Products
Category:
Drugs and Chemicals (Pharma)
,
All FDA Regulated Industry
,
GXP Pharmaceutical
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Laboratory
,
Drugs Regulations
,
Life sciences QA/QC
,
Supply chain & Procurement
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
