Expert Profile
John R Godshalk
Senior Consultant, Biologics Consulting Group
John R. Godshalk, B.S., MBA, is a Senior Consultant with the Biologics Consulting Group, Inc.
During his tenure at DMPQ, John gained experience with products that include drugs, drug/device combination products, viral and bacterial vaccines, recombinant therapeutic and fractionation products, in vitro diagnostic test kits, and 510K medical devices. His inspection experience includes leading inspections of active pharmaceutical ingredient manufacturers, aseptic filling and finishing facilities, and contract manufacturers. He has performed numerous pre-approval and pre-licensing inspections for biological and biotechnology products. In addition, he has evaluated industry responses both for technical and regulatory merit during FDA regulatory compliance actions, and has assessed these responses and offered alternative solutions to resolve technical issues and regulatory concerns.
John has developed and given training programs for the FDA and regulated industry on pharmaceutical water, processing and instrumentation, lyophilization, cleaning methods and validation, and facilities for cell and gene therapy. He contributed to formulation of FDA policy as a member of the committee writing the Guidance Document for the Facilities and Controls for Cellular and Gene Therapy Product Manufacturing Operations.
John has served as chair in the review of the Chemistry Manufacturing and Controls (CMC) sections of Biologics License Applications and Supplements for both novel and licensed biological products at CBER. He has trained CBER staff on the scientific and regulatory review and evaluation of these applications and supplements.
Prior to joining FDA, John was a research engineer in industrial biotech. He also used his business experience and MBA as a consultant in the areas of business planning, marketing, information technology and strategic planning, financial modeling and analysis, budgeting, business process engineering, project management, and management consulting.
Trainings by Expert
Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience
Category:
Drugs and Chemicals (Pharma)
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Medical Devices
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Biotechnology
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All FDA Regulated Industry
,
GXP Pharmaceutical
,
GXP Medical Devices
,
FDA Validation
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Testing and Validation
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Quality & Safety
,
Biologics and Biosimilars
,
Drugs Regulations
,
Biotech Regulations
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
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Regulations & Guidances
,
Best Practices & GXPs
,
Life Sciences
,
Regulatory Affairs
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Documentation and Data Management
,
Common FDA Regulations
,
QA/QC
Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
Category:
Drugs and Chemicals (Pharma)
,
Biotechnology
,
All FDA Regulated Industry
,
GXP Pharmaceutical
,
Quality and Safety
,
Quality & Safety
,
Biologics and Biosimilars
,
Drugs Regulations
,
Biotech Regulations
,
Regulations & Guidances
,
Best Practices & GXPs
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
Lyophilization: What you Need to Know, Validation and Regulatory Approaches
Category:
Drugs and Chemicals (Pharma)
,
All FDA Regulated Industry
,
FDA Audit and Inspection
,
GXP Pharmaceutical
,
Quality and Safety
,
Audits & Inspections
,
Supply Chain and Manufacturing
,
Drug Development
,
Food & Dietary Supplements
,
Manufacturing & Contamination control
,
Drugs Regulations
,
Audit & Inspection-Role
,
All FDA Reg. based Audit
,
Food Safety & Quality
,
Life sciences QA/QC
,
Research & Development
,
Drug R & D
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
Good Deviation Practice: What You Need to Know
Category:
All FDA Regulated Industry
,
Quality and Safety
,
Life sciences QA/QC
,
Compliance & Ethics
,
Regulations & Guidances
,
Best Practices & GXPs
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
Process Validation - Current Industry Practices and FDA Guidance Document Review
Category:
Drugs and Chemicals (Pharma)
,
All FDA Regulated Industry
,
GXP Pharmaceutical
,
Documentation and IT
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Drugs Regulations
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
FDA Data Integrity Training: Pack of 6 Training Courses
Category:
Drugs and Chemicals (Pharma)
