SlideShare ist ein Scribd-Unternehmen logo

FDA Regulation of Cellular and Tissue-based Products

•Als PPT, PDF herunterladen•
•
W
wrtolbert

The document discusses regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) established by the U.S. Food and Drug Administration (FDA) under 21 CFR Part 1271. It provides an overview of the key requirements including establishment registration and listing, donor eligibility screening, adherence to current good tissue practice standards, inspection and enforcement, and the tiered regulatory framework for HCT/Ps. It also compares the new regulations to existing cGMP and quality system regulations.

1 von 52
WR Tolbert & Associates Consultants to the Biopharmaceutical Industry 11483 Cypress Woods Drive San Diego, CA 92131-3535 858-693-8163 wrt@wrtolbert.com / www.wrtolbert.com
Dogs Bark, Cows Moo, Regulators Regulate... Frank Young, M.D. former FDA Commissioner
FDA History ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
FDA’s Purpose ,[object Object],[object Object],[object Object],[object Object],[object Object]
FDA “Centers” ,[object Object],[object Object],[object Object]
FDA Inspections ,[object Object],[object Object]
Foreign Regulatory Agencies ,[object Object],[object Object],[object Object],[object Object]
Information Sources ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Information Sources ,[object Object],[object Object],[object Object]
The Primary Requirement / Roadblock ,[object Object],[object Object],[object Object],[object Object],[object Object]
FDA Tools ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Cross Regulation Themes and Concerns ,[object Object],[object Object],[object Object],[object Object],[object Object]
The Existing Regulatory Environment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
How are Cell-Based Products Different? ,[object Object],[object Object],[object Object],[object Object]
FDA Driving Forces & Challenges for Cell Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Cell and Tissue Characteristics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
FDA Regulation of Cellular and Tissue-based Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New FDA Regulation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
21 CFR Part 1271
Regulatory Requirements for HCT/P’s
21 CFR Part 1271 Establishment Registration and Listing ,[object Object],[object Object],[object Object]
21 CFR Part 1271 Donor Eligibility ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
21 CFR Part 1271 Good Tissue Practices ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
21 CFR Part 1271 Inspection and Enforcement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
21 CFR Part 1271 Inspection and Enforcement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Compliance to cGMPs, QSRs, and Biologics Regulations vs. cGTPs ,[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Comparison cGMPs vs. cGTPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
FDA Inspections ,[object Object],[object Object],[object Object],[object Object],[object Object]
cGMP Sanctions ,[object Object],[object Object],[object Object]
Additional Valuable cGMP Information ,[object Object],[object Object],[object Object],[object Object]
Open vs. Closed Manufacturing Systems ,[object Object],[object Object]
WRT&A
Material and Supply Flow WRT&A
WRT&A
WRT&A

Empfohlen

current Good Tissue Practice
current Good Tissue Practice current Good Tissue Practice
current Good Tissue Practice Arete-Zoe, LLC
 
Doc in pharma
Doc in pharmaDoc in pharma
Doc in pharmamaitreyi zaveri
 
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATES
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATESQUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATES
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATESvasanthi chodavarapu
 
FDA PreApproval Inspection - Part 1
FDA PreApproval Inspection - Part 1FDA PreApproval Inspection - Part 1
FDA PreApproval Inspection - Part 1Jorge Torres
 
GMP- APQR training
GMP- APQR trainingGMP- APQR training
GMP- APQR trainingAmsavel Vel
 
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning LettersHow to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning LettersGreenlight Guru
 
Deviation and root cause analysis in Pharma
Deviation and root cause analysis in PharmaDeviation and root cause analysis in Pharma
Deviation and root cause analysis in PharmaSubhash Sanghani
 
Gmp Auditor Training Course
Gmp Auditor Training CourseGmp Auditor Training Course
Gmp Auditor Training Coursepiyush64173
 

Empfohlen

current Good Tissue Practice
current Good Tissue Practice current Good Tissue Practice
current Good Tissue Practice Arete-Zoe, LLC
 
Doc in pharma
Doc in pharmaDoc in pharma
Doc in pharmamaitreyi zaveri
 
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATES
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATESQUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATES
QUALITY SYSTEM REQUIREMENTS FOR NATIONAL GMP INSPECTORATESvasanthi chodavarapu
 
FDA PreApproval Inspection - Part 1
FDA PreApproval Inspection - Part 1FDA PreApproval Inspection - Part 1
FDA PreApproval Inspection - Part 1Jorge Torres
 
GMP- APQR training
GMP- APQR trainingGMP- APQR training
GMP- APQR trainingAmsavel Vel
 
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning LettersHow to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning LettersGreenlight Guru
 
Deviation and root cause analysis in Pharma
Deviation and root cause analysis in PharmaDeviation and root cause analysis in Pharma
Deviation and root cause analysis in PharmaSubhash Sanghani
 
Gmp Auditor Training Course
Gmp Auditor Training CourseGmp Auditor Training Course
Gmp Auditor Training Coursepiyush64173
 
Product life cycle management
Product life cycle managementProduct life cycle management
Product life cycle managementVikas Rathee
 
Pharmaceutical development report (pdr)
Pharmaceutical development report (pdr)Pharmaceutical development report (pdr)
Pharmaceutical development report (pdr)Atul Bhombe
 
ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration
ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration
ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration Anil Chaudhari
 
Good Automated Laboratory Practices
Good Automated Laboratory PracticesGood Automated Laboratory Practices
Good Automated Laboratory PracticesSwapnil Fernandes
 
GMP compliances of Audit
GMP compliances of AuditGMP compliances of Audit
GMP compliances of AuditMegha bhise
 
FDA GMP Training - The Quality Audit
FDA GMP Training - The Quality AuditFDA GMP Training - The Quality Audit
FDA GMP Training - The Quality AuditCompliance Insight, Inc.
 
FDA 483
FDA 483FDA 483
FDA 483Compliance Insight, Inc.
 
Quality metrices
Quality metricesQuality metrices
Quality metricesrasika walunj
 
Capa
CapaCapa
CapaJohn E. Osani
 
change control
change controlchange control
change controlSrinivasaReddy137
 
ANVISA regulatory authority of brazil
ANVISA regulatory authority of brazilANVISA regulatory authority of brazil
ANVISA regulatory authority of brazilGaurav Kr
 
Content and format of dossier filling in india
Content and format of dossier filling in india Content and format of dossier filling in india
Content and format of dossier filling in india sandeep bansal
 
BPR review and batch release
BPR review and batch release BPR review and batch release
BPR review and batch release Dr. Amsavel A
 
INVESTIGATIONAL DEVICE EXEMPTIONS.pptx
INVESTIGATIONAL DEVICE EXEMPTIONS.pptxINVESTIGATIONAL DEVICE EXEMPTIONS.pptx
INVESTIGATIONAL DEVICE EXEMPTIONS.pptxPrachiSharma575050
 
21 cfr part 210 and 211
21 cfr part 210 and 21121 cfr part 210 and 211
21 cfr part 210 and 211Bhanu Chava
 
plasma master file in European countries and requirements in letter of intent...
plasma master file in European countries and requirements in letter of intent...plasma master file in European countries and requirements in letter of intent...
plasma master file in European countries and requirements in letter of intent...Sanjay batra
 
Who good distributionpracticesforpharmaceuticalproducts
Who good distributionpracticesforpharmaceuticalproductsWho good distributionpracticesforpharmaceuticalproducts
Who good distributionpracticesforpharmaceuticalproductsadeelzia84
 
Handling of Out of Specification Results
Handling of Out of Specification ResultsHandling of Out of Specification Results
Handling of Out of Specification ResultsGMP EDUCATION : Not for Profit Organization
 
Capa presentation
Capa presentationCapa presentation
Capa presentationDr. P.K. NARASIMHA RAGHAVAN
 
Documentation in Pharmaceutical Industry Part I
Documentation in Pharmaceutical Industry Part I Documentation in Pharmaceutical Industry Part I
Documentation in Pharmaceutical Industry Part I Tarif Hussian
 
Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...
Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...
Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...wrtolbert
 
FDA News Webinar - Inspection Intelligence
FDA News Webinar - Inspection IntelligenceFDA News Webinar - Inspection Intelligence
FDA News Webinar - Inspection IntelligenceArmin Torres
 

Weitere ähnliche Inhalte

Was ist angesagt?

Product life cycle management
Product life cycle managementProduct life cycle management
Product life cycle managementVikas Rathee
 
Pharmaceutical development report (pdr)
Pharmaceutical development report (pdr)Pharmaceutical development report (pdr)
Pharmaceutical development report (pdr)Atul Bhombe
 
ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration
ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration
ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration Anil Chaudhari
 
Good Automated Laboratory Practices
Good Automated Laboratory PracticesGood Automated Laboratory Practices
Good Automated Laboratory PracticesSwapnil Fernandes
 
GMP compliances of Audit
GMP compliances of AuditGMP compliances of Audit
GMP compliances of AuditMegha bhise
 
ANVISA regulatory authority of brazil
ANVISA regulatory authority of brazilANVISA regulatory authority of brazil
ANVISA regulatory authority of brazilGaurav Kr
 
Content and format of dossier filling in india
Content and format of dossier filling in india Content and format of dossier filling in india
Content and format of dossier filling in india sandeep bansal
 
BPR review and batch release
BPR review and batch release BPR review and batch release
BPR review and batch release Dr. Amsavel A
 
INVESTIGATIONAL DEVICE EXEMPTIONS.pptx
INVESTIGATIONAL DEVICE EXEMPTIONS.pptxINVESTIGATIONAL DEVICE EXEMPTIONS.pptx
INVESTIGATIONAL DEVICE EXEMPTIONS.pptxPrachiSharma575050
 
21 cfr part 210 and 211
21 cfr part 210 and 21121 cfr part 210 and 211
21 cfr part 210 and 211Bhanu Chava
 
plasma master file in European countries and requirements in letter of intent...
plasma master file in European countries and requirements in letter of intent...plasma master file in European countries and requirements in letter of intent...
plasma master file in European countries and requirements in letter of intent...Sanjay batra
 
Who good distributionpracticesforpharmaceuticalproducts
Who good distributionpracticesforpharmaceuticalproductsWho good distributionpracticesforpharmaceuticalproducts
Who good distributionpracticesforpharmaceuticalproductsadeelzia84
 
Documentation in Pharmaceutical Industry Part I
Documentation in Pharmaceutical Industry Part I Documentation in Pharmaceutical Industry Part I
Documentation in Pharmaceutical Industry Part I Tarif Hussian
 

Was ist angesagt? (20)

Product life cycle management
Product life cycle managementProduct life cycle management
Product life cycle management
 
Pharmaceutical development report (pdr)
Pharmaceutical development report (pdr)Pharmaceutical development report (pdr)
Pharmaceutical development report (pdr)
 
ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration
ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration
ISO 13485 Consulting | ISO 13485 Certification| Medical Device Registration
 
Good Automated Laboratory Practices
Good Automated Laboratory PracticesGood Automated Laboratory Practices
Good Automated Laboratory Practices
 
GMP compliances of Audit
GMP compliances of AuditGMP compliances of Audit
GMP compliances of Audit
 
FDA GMP Training - The Quality Audit
FDA GMP Training - The Quality AuditFDA GMP Training - The Quality Audit
FDA GMP Training - The Quality Audit
 
FDA 483
FDA 483FDA 483
FDA 483
 
Quality metrices
Quality metricesQuality metrices
Quality metrices
 
Capa
CapaCapa
Capa
 
change control
change controlchange control
change control
 
ANVISA regulatory authority of brazil
ANVISA regulatory authority of brazilANVISA regulatory authority of brazil
ANVISA regulatory authority of brazil
 
Content and format of dossier filling in india
Content and format of dossier filling in india Content and format of dossier filling in india
Content and format of dossier filling in india
 
BPR review and batch release
BPR review and batch release BPR review and batch release
BPR review and batch release
 
INVESTIGATIONAL DEVICE EXEMPTIONS.pptx
INVESTIGATIONAL DEVICE EXEMPTIONS.pptxINVESTIGATIONAL DEVICE EXEMPTIONS.pptx
INVESTIGATIONAL DEVICE EXEMPTIONS.pptx
 
21 cfr part 210 and 211
21 cfr part 210 and 21121 cfr part 210 and 211
21 cfr part 210 and 211
 
plasma master file in European countries and requirements in letter of intent...
plasma master file in European countries and requirements in letter of intent...plasma master file in European countries and requirements in letter of intent...
plasma master file in European countries and requirements in letter of intent...
 
Who good distributionpracticesforpharmaceuticalproducts
Who good distributionpracticesforpharmaceuticalproductsWho good distributionpracticesforpharmaceuticalproducts
Who good distributionpracticesforpharmaceuticalproducts
 
Handling of Out of Specification Results
Handling of Out of Specification ResultsHandling of Out of Specification Results
Handling of Out of Specification Results
 
Capa presentation
Capa presentationCapa presentation
Capa presentation
 
Documentation in Pharmaceutical Industry Part I
Documentation in Pharmaceutical Industry Part I Documentation in Pharmaceutical Industry Part I
Documentation in Pharmaceutical Industry Part I
 

Andere mochten auch

Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...
Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...
Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...wrtolbert
 
FDA News Webinar - Inspection Intelligence
FDA News Webinar - Inspection IntelligenceFDA News Webinar - Inspection Intelligence
FDA News Webinar - Inspection IntelligenceArmin Torres
 
Stem cells: Information environment
Stem cells: Information environmentStem cells: Information environment
Stem cells: Information environmentArete-Zoe, LLC
 
Gmp premises 112070804006
Gmp premises 112070804006Gmp premises 112070804006
Gmp premises 112070804006Patel Parth
 
Quality Assurance Vs Quality Control
Quality Assurance Vs Quality ControlQuality Assurance Vs Quality Control
Quality Assurance Vs Quality ControlYogita patil
 
InstantGMP Compliance Series - Facility Areas
InstantGMP Compliance Series - Facility AreasInstantGMP Compliance Series - Facility Areas
InstantGMP Compliance Series - Facility AreasInstantGMP™
 

Andere mochten auch (9)

Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...
Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...
Gene Therapy / Cell Therapy / Stem Cells – Regulations for the "New Biol...
 
FDA News Webinar - Inspection Intelligence
FDA News Webinar - Inspection IntelligenceFDA News Webinar - Inspection Intelligence
FDA News Webinar - Inspection Intelligence
 
Stem cells: Information environment
Stem cells: Information environmentStem cells: Information environment
Stem cells: Information environment
 
Gmp & glp
Gmp & glpGmp & glp
Gmp & glp
 
Gmp premises 112070804006
Gmp premises 112070804006Gmp premises 112070804006
Gmp premises 112070804006
 
GMP
GMPGMP
GMP
 
Quality Assurance Vs Quality Control
Quality Assurance Vs Quality ControlQuality Assurance Vs Quality Control
Quality Assurance Vs Quality Control
 
InstantGMP Compliance Series - Facility Areas
InstantGMP Compliance Series - Facility AreasInstantGMP Compliance Series - Facility Areas
InstantGMP Compliance Series - Facility Areas
 
Pharmaceutical manufacturing plant
Pharmaceutical manufacturing plantPharmaceutical manufacturing plant
Pharmaceutical manufacturing plant
 

Ähnlich wie FDA Regulation of Cellular and Tissue-based Products

Good Manufacturing Practices
Good Manufacturing PracticesGood Manufacturing Practices
Good Manufacturing PracticesJorge Torres
 
FDA 2013 Clinical Investigator Training Course: How to put together an Applic...
FDA 2013 Clinical Investigator Training Course: How to put together an Applic...FDA 2013 Clinical Investigator Training Course: How to put together an Applic...
FDA 2013 Clinical Investigator Training Course: How to put together an Applic...MedicReS
 
Regulation of Medical Devices in US
Regulation of Medical Devices in USRegulation of Medical Devices in US
Regulation of Medical Devices in USAnkit Geete
 
USFDA GUIDLINES
USFDA GUIDLINESUSFDA GUIDLINES
USFDA GUIDLINESRaj Tiwari
 
Understanding FDA Requirements Medical Devices
Understanding FDA Requirements Medical DevicesUnderstanding FDA Requirements Medical Devices
Understanding FDA Requirements Medical Devicesmarchell
 
Planning Clinical Trial in USA.pdf
Planning Clinical Trial in USA.pdfPlanning Clinical Trial in USA.pdf
Planning Clinical Trial in USA.pdfProRelix Research
 
Understanding FDA Regulations
Understanding FDA RegulationsUnderstanding FDA Regulations
Understanding FDA RegulationsBeth Friedland
 
Quality regulation for biological products current and future
Quality regulation for biological products current and futureQuality regulation for biological products current and future
Quality regulation for biological products current and futureNational Institute of Biologics
 
FDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to MarketFDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
 
FDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to MarketFDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
 
Avoiding Pitfalls in the Regulatory Path - MaRS Best Practices
Avoiding Pitfalls in the Regulatory Path - MaRS Best PracticesAvoiding Pitfalls in the Regulatory Path - MaRS Best Practices
Avoiding Pitfalls in the Regulatory Path - MaRS Best PracticesMaRS Discovery District
 
Regulatory requirement for approval of Biologics
Regulatory requirement for approval of BiologicsRegulatory requirement for approval of Biologics
Regulatory requirement for approval of BiologicsArpitha Aarushi
 
FDA classify Medical Devices and how to report device problems A Systematic R...
FDA classify Medical Devices and how to report device problems A Systematic R...FDA classify Medical Devices and how to report device problems A Systematic R...
FDA classify Medical Devices and how to report device problems A Systematic R...Pubrica
 
FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate
FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate
FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate MedicReS
 
DESIGN OF IMPLANTABLE DEVICE – UNDERSTANDING THE PREMARKET REVIEW PROCESS AN...
DESIGN OF IMPLANTABLE DEVICE – UNDERSTANDING THE PREMARKET REVIEW PROCESS AN...DESIGN OF IMPLANTABLE DEVICE – UNDERSTANDING THE PREMARKET REVIEW PROCESS AN...
DESIGN OF IMPLANTABLE DEVICE – UNDERSTANDING THE PREMARKET REVIEW PROCESS AN...UBMCanon
 
Chap2 CTPMR, 2nd Ed. 2016
Chap2 CTPMR, 2nd Ed. 2016Chap2 CTPMR, 2nd Ed. 2016
Chap2 CTPMR, 2nd Ed. 2016Eric Dollins
 
The Rough Waters of the Regulatory Environment
The Rough Waters of the Regulatory EnvironmentThe Rough Waters of the Regulatory Environment
The Rough Waters of the Regulatory EnvironmentJonathan Servoss
 

Ähnlich wie FDA Regulation of Cellular and Tissue-based Products (20)

Good Manufacturing Practices
Good Manufacturing PracticesGood Manufacturing Practices
Good Manufacturing Practices
 
FDA 2013 Clinical Investigator Training Course: How to put together an Applic...
FDA 2013 Clinical Investigator Training Course: How to put together an Applic...FDA 2013 Clinical Investigator Training Course: How to put together an Applic...
FDA 2013 Clinical Investigator Training Course: How to put together an Applic...
 
Regulation of Medical Devices in US
Regulation of Medical Devices in USRegulation of Medical Devices in US
Regulation of Medical Devices in US
 
USFDA GUIDLINES
USFDA GUIDLINESUSFDA GUIDLINES
USFDA GUIDLINES
 
Understanding FDA Requirements Medical Devices
Understanding FDA Requirements Medical DevicesUnderstanding FDA Requirements Medical Devices
Understanding FDA Requirements Medical Devices
 
Planning Clinical Trial in USA.pdf
Planning Clinical Trial in USA.pdfPlanning Clinical Trial in USA.pdf
Planning Clinical Trial in USA.pdf
 
Understanding FDA Regulations
Understanding FDA RegulationsUnderstanding FDA Regulations
Understanding FDA Regulations
 
Quality regulation for biological products current and future
Quality regulation for biological products current and futureQuality regulation for biological products current and future
Quality regulation for biological products current and future
 
FDA Regulations
FDA RegulationsFDA Regulations
FDA Regulations
 
FDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to MarketFDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to Market
 
FDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to MarketFDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to Market
 
Avoiding Pitfalls in the Regulatory Path - MaRS Best Practices
Avoiding Pitfalls in the Regulatory Path - MaRS Best PracticesAvoiding Pitfalls in the Regulatory Path - MaRS Best Practices
Avoiding Pitfalls in the Regulatory Path - MaRS Best Practices
 
Gcp
GcpGcp
Gcp
 
Advamed MDR IVDR update
Advamed MDR IVDR updateAdvamed MDR IVDR update
Advamed MDR IVDR update
 
Regulatory requirement for approval of Biologics
Regulatory requirement for approval of BiologicsRegulatory requirement for approval of Biologics
Regulatory requirement for approval of Biologics
 
FDA classify Medical Devices and how to report device problems A Systematic R...
FDA classify Medical Devices and how to report device problems A Systematic R...FDA classify Medical Devices and how to report device problems A Systematic R...
FDA classify Medical Devices and how to report device problems A Systematic R...
 
FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate
FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate
FDA 2013 Clinical Investigator Training Course: FDA Structure and Mandate
 
DESIGN OF IMPLANTABLE DEVICE – UNDERSTANDING THE PREMARKET REVIEW PROCESS AN...
DESIGN OF IMPLANTABLE DEVICE – UNDERSTANDING THE PREMARKET REVIEW PROCESS AN...DESIGN OF IMPLANTABLE DEVICE – UNDERSTANDING THE PREMARKET REVIEW PROCESS AN...
DESIGN OF IMPLANTABLE DEVICE – UNDERSTANDING THE PREMARKET REVIEW PROCESS AN...
 
Chap2 CTPMR, 2nd Ed. 2016
Chap2 CTPMR, 2nd Ed. 2016Chap2 CTPMR, 2nd Ed. 2016
Chap2 CTPMR, 2nd Ed. 2016
 
The Rough Waters of the Regulatory Environment
The Rough Waters of the Regulatory EnvironmentThe Rough Waters of the Regulatory Environment
The Rough Waters of the Regulatory Environment
 

FDA Regulation of Cellular and Tissue-based Products

  • 1. WR Tolbert & Associates Consultants to the Biopharmaceutical Industry 11483 Cypress Woods Drive San Diego, CA 92131-3535 858-693-8163 wrt@wrtolbert.com / www.wrtolbert.com
  • 2. Dogs Bark, Cows Moo, Regulators Regulate... Frank Young, M.D. former FDA Commissioner
  • 3.
  • 4.  
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20. 21 CFR Part 1271
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.
  • 32.
  • 33.
  • 34.
  • 35.
  • 36.
  • 37.
  • 38.
  • 39.
  • 40.
  • 41.
  • 42.
  • 43.
  • 44.
  • 45.
  • 46.
  • 47.
  • 48.
  • 49. WRT&A
  • 50. Material and Supply Flow WRT&A
  • 51. WRT&A
  • 52. WRT&A