SlideShare a Scribd company logo

Quality and Regulatory Affairs

•
•
MaRS Discovery District
MaRS Discovery District

James Ault, VP Quality and Regulatory Affairs, Ricerca Biosciences, LLC discusses Regulatory IND Process for drug discovery as part of a pre-clinical development workshop. Available for download from the <a href="http://www.marsdd.com/servlets/sfs?t=/contentManager/onStory&e=UTF-8&i=1125077882365&l=0&s=KViiqiXDtBtVMFUcybn&active=no&ParentID=1138394059511&sort=Price&StoryID=1168016720154" target="_blank">MaRS website at www.marsdd.com</a>.

Business
1 of 29
Regulatory IND Process James Ault, RAC, RQAP-GLP VP Quality and Regulatory Affairs Ricerca Biosciences, LLC May 23, 2007 Quality and Regulatory Affairs
Regulatory IND Process ,[object Object],[object Object],[object Object]
Regulatory IND Process ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Fundamental Principle ,[object Object]
What is “Substantial Evidence”? ,[object Object],[object Object],[object Object],[object Object]
Here’s What the FDA Wants from You ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
When Do You File an IND? ,[object Object],[object Object],[object Object]
Regulatory Strategy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Strategy ,[object Object]
Regulatory Strategy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Strategy ,[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Strategy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Strategy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IND Application ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IND Item 7: Chemistry, Manufacturing and Controls ,[object Object],[object Object]
IND Item 7: Chemistry, Manufacturing and Controls ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IND Item 7: Chemistry, Manufacturing and Controls ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What is cGMP? Good Manufacturing Practices Shipping/Receiving Raw Mats/Supplies Quarantine-Test-Release Processing - batch records Validated facilities/equip. Good documentation Test product Documentation reviewed by QA - Release/Reject Label and ship to client Archive data and records Wait for FDA to appear
IND Item 8: Non-clinical Pharmacology and Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IND Item 8: Non-clinical Pharmacology and Toxicology ,[object Object],[object Object],[object Object],[object Object]
IND Item 8: Non-clinical Pharmacology and Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object]
What is GLP? Good Laboratory Practices Adequate Facility Qualified Personnel - Technical and Quality Unit Protocol and SD Unique Suitable Test Systems Characterized Test Materials/Controls Effective SOPs Accurate/Timely Data Accurate/Complete Report Secure Archives
FDA’s Role Reviewing IND Submissions ,[object Object],[object Object],[object Object],[object Object]
Grounds for IND Clinical Hold ,[object Object],[object Object],[object Object],[object Object],[object Object]
Causes for Rejection ,[object Object],[object Object],[object Object],[object Object],[object Object]
FDA’s Regulatory Aspect - IND ,[object Object],[object Object],[object Object],[object Object]
Agency Interaction/Meetings ,[object Object],[object Object],[object Object],[object Object]
Agency Interaction/Meetings ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory IND Process ,[object Object],[object Object],[object Object]

Recommended

Obtaining Clinical/Regulatory Approval for Medical Devices in a Global Market
Obtaining Clinical/Regulatory Approval for Medical Devices in a Global MarketObtaining Clinical/Regulatory Approval for Medical Devices in a Global Market
Obtaining Clinical/Regulatory Approval for Medical Devices in a Global MarketMedpace
 
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Best Practices
 
Biosimilar Development Regulatory, Analytical, and Clinical Considerations
Biosimilar Development Regulatory, Analytical, and Clinical Considerations Biosimilar Development Regulatory, Analytical, and Clinical Considerations
Biosimilar Development Regulatory, Analytical, and Clinical Considerations SGS
 
Regulatory Affairs: Department Models and Structures
Regulatory Affairs: Department Models and StructuresRegulatory Affairs: Department Models and Structures
Regulatory Affairs: Department Models and StructuresIndustry Standard Research
 
Quality and Regulatory Affairs
Quality and Regulatory AffairsQuality and Regulatory Affairs
Quality and Regulatory AffairsMaRS Discovery District
 
BioMedical Strategy - Regulatory Presentation
BioMedical Strategy - Regulatory PresentationBioMedical Strategy - Regulatory Presentation
BioMedical Strategy - Regulatory PresentationBioMedical Strategy (2004) Ltd.
 
Pharma Regulatory Affairs
Pharma Regulatory AffairsPharma Regulatory Affairs
Pharma Regulatory Affairsbiinoida
 
Presentation on EU Regulatory & Quality System.
Presentation on EU Regulatory & Quality System.Presentation on EU Regulatory & Quality System.
Presentation on EU Regulatory & Quality System.GMP EDUCATION : Not for Profit Organization
 

Recommended

Obtaining Clinical/Regulatory Approval for Medical Devices in a Global Market
Obtaining Clinical/Regulatory Approval for Medical Devices in a Global MarketObtaining Clinical/Regulatory Approval for Medical Devices in a Global Market
Obtaining Clinical/Regulatory Approval for Medical Devices in a Global MarketMedpace
 
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Best Practices
 
Biosimilar Development Regulatory, Analytical, and Clinical Considerations
Biosimilar Development Regulatory, Analytical, and Clinical Considerations Biosimilar Development Regulatory, Analytical, and Clinical Considerations
Biosimilar Development Regulatory, Analytical, and Clinical Considerations SGS
 
Regulatory Affairs: Department Models and Structures
Regulatory Affairs: Department Models and StructuresRegulatory Affairs: Department Models and Structures
Regulatory Affairs: Department Models and StructuresIndustry Standard Research
 
Quality and Regulatory Affairs
Quality and Regulatory AffairsQuality and Regulatory Affairs
Quality and Regulatory AffairsMaRS Discovery District
 
BioMedical Strategy - Regulatory Presentation
BioMedical Strategy - Regulatory PresentationBioMedical Strategy - Regulatory Presentation
BioMedical Strategy - Regulatory PresentationBioMedical Strategy (2004) Ltd.
 
Pharma Regulatory Affairs
Pharma Regulatory AffairsPharma Regulatory Affairs
Pharma Regulatory Affairsbiinoida
 
Presentation on EU Regulatory & Quality System.
Presentation on EU Regulatory & Quality System.Presentation on EU Regulatory & Quality System.
Presentation on EU Regulatory & Quality System.GMP EDUCATION : Not for Profit Organization
 
Don Tapscott's New Solutions for a Connected Planet - MaRS Global Leadership
Don Tapscott's New Solutions for a Connected Planet - MaRS Global LeadershipDon Tapscott's New Solutions for a Connected Planet - MaRS Global Leadership
Don Tapscott's New Solutions for a Connected Planet - MaRS Global LeadershipMaRS Discovery District
 
Closing Remarks by Tom Rand
Closing Remarks by Tom RandClosing Remarks by Tom Rand
Closing Remarks by Tom RandMaRS Discovery District
 
Supporting the commercialization of new energy technology by Kaliyur Sridharan
Supporting the commercialization of new energy technology by Kaliyur SridharanSupporting the commercialization of new energy technology by Kaliyur Sridharan
Supporting the commercialization of new energy technology by Kaliyur SridharanMaRS Discovery District
 
Supporting the commercialization of new energy technology by Celine Bak
Supporting the commercialization of new energy technology by Celine BakSupporting the commercialization of new energy technology by Celine Bak
Supporting the commercialization of new energy technology by Celine BakMaRS Discovery District
 
Supporting the commercialization of new energy technology by Annette Verschuren
Supporting the commercialization of new energy technology by Annette VerschurenSupporting the commercialization of new energy technology by Annette Verschuren
Supporting the commercialization of new energy technology by Annette VerschurenMaRS Discovery District
 
Emerging energy generation and storage technology by Ken Nakahara
Emerging energy generation and storage technology by Ken NakaharaEmerging energy generation and storage technology by Ken Nakahara
Emerging energy generation and storage technology by Ken NakaharaMaRS Discovery District
 
Emerging energy generation and storage technology by Ted Sargent
Emerging energy generation and storage technology by Ted SargentEmerging energy generation and storage technology by Ted Sargent
Emerging energy generation and storage technology by Ted SargentMaRS Discovery District
 
Emerging energy generation and storage technology by Mark Tinkler
Emerging energy generation and storage technology by Mark TinklerEmerging energy generation and storage technology by Mark Tinkler
Emerging energy generation and storage technology by Mark TinklerMaRS Discovery District
 
Emerging energy generation and storage technology by John MacRitchie
Emerging energy generation and storage technology by John MacRitchieEmerging energy generation and storage technology by John MacRitchie
Emerging energy generation and storage technology by John MacRitchieMaRS Discovery District
 
Lunch keynote by Minister Duguid
Lunch keynote by Minister DuguidLunch keynote by Minister Duguid
Lunch keynote by Minister DuguidMaRS Discovery District
 
Combining different energy sources and uses by David Teichroeb
Combining different energy sources and uses by David TeichroebCombining different energy sources and uses by David Teichroeb
Combining different energy sources and uses by David TeichroebMaRS Discovery District
 
Combining different energy sources and uses by Joe Cargnelli
Combining different energy sources and uses by Joe CargnelliCombining different energy sources and uses by Joe Cargnelli
Combining different energy sources and uses by Joe CargnelliMaRS Discovery District
 
Combining different energy sources and uses by Murray McCaig
Combining different energy sources and uses by Murray McCaigCombining different energy sources and uses by Murray McCaig
Combining different energy sources and uses by Murray McCaigMaRS Discovery District
 
Designing the grid of the future by Ravi Seethapathy
Designing the grid of the future by Ravi SeethapathyDesigning the grid of the future by Ravi Seethapathy
Designing the grid of the future by Ravi SeethapathyMaRS Discovery District
 
Designing the grid of the future by Darren Finkbeiner
Designing the grid of the future by Darren FinkbeinerDesigning the grid of the future by Darren Finkbeiner
Designing the grid of the future by Darren FinkbeinerMaRS Discovery District
 
Designing the grid of the future by Stefan Kuppers
Designing the grid of the future by Stefan KuppersDesigning the grid of the future by Stefan Kuppers
Designing the grid of the future by Stefan KuppersMaRS Discovery District
 
Using the power of data by David Wollman
Using the power of data by David WollmanUsing the power of data by David Wollman
Using the power of data by David WollmanMaRS Discovery District
 
Introduction by ann cavoukian
Introduction by ann cavoukianIntroduction by ann cavoukian
Introduction by ann cavoukianMaRS Discovery District
 
Introduction by ann cavoukian
Introduction by ann cavoukianIntroduction by ann cavoukian
Introduction by ann cavoukianMaRS Discovery District
 
SR&ED: What you need to know about the changing landscape - MaRS Best Practices
SR&ED: What you need to know about the changing landscape - MaRS Best PracticesSR&ED: What you need to know about the changing landscape - MaRS Best Practices
SR&ED: What you need to know about the changing landscape - MaRS Best PracticesMaRS Discovery District
 
Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
Best VIP Call Girls Noida Sector 40 Call Me: 8448380779Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
Best VIP Call Girls Noida Sector 40 Call Me: 8448380779Delhi Call girls
 
Unlocking the Secrets of Affiliate Marketing.pdf
Unlocking the Secrets of Affiliate Marketing.pdfUnlocking the Secrets of Affiliate Marketing.pdf
Unlocking the Secrets of Affiliate Marketing.pdfOnline Income Engine
 

More Related Content

More from MaRS Discovery District

Don Tapscott's New Solutions for a Connected Planet - MaRS Global Leadership
Don Tapscott's New Solutions for a Connected Planet - MaRS Global LeadershipDon Tapscott's New Solutions for a Connected Planet - MaRS Global Leadership
Don Tapscott's New Solutions for a Connected Planet - MaRS Global LeadershipMaRS Discovery District
 
Supporting the commercialization of new energy technology by Kaliyur Sridharan
Supporting the commercialization of new energy technology by Kaliyur SridharanSupporting the commercialization of new energy technology by Kaliyur Sridharan
Supporting the commercialization of new energy technology by Kaliyur SridharanMaRS Discovery District
 
Supporting the commercialization of new energy technology by Celine Bak
Supporting the commercialization of new energy technology by Celine BakSupporting the commercialization of new energy technology by Celine Bak
Supporting the commercialization of new energy technology by Celine BakMaRS Discovery District
 
Supporting the commercialization of new energy technology by Annette Verschuren
Supporting the commercialization of new energy technology by Annette VerschurenSupporting the commercialization of new energy technology by Annette Verschuren
Supporting the commercialization of new energy technology by Annette VerschurenMaRS Discovery District
 
Emerging energy generation and storage technology by Ken Nakahara
Emerging energy generation and storage technology by Ken NakaharaEmerging energy generation and storage technology by Ken Nakahara
Emerging energy generation and storage technology by Ken NakaharaMaRS Discovery District
 
Emerging energy generation and storage technology by Ted Sargent
Emerging energy generation and storage technology by Ted SargentEmerging energy generation and storage technology by Ted Sargent
Emerging energy generation and storage technology by Ted SargentMaRS Discovery District
 
Emerging energy generation and storage technology by Mark Tinkler
Emerging energy generation and storage technology by Mark TinklerEmerging energy generation and storage technology by Mark Tinkler
Emerging energy generation and storage technology by Mark TinklerMaRS Discovery District
 
Emerging energy generation and storage technology by John MacRitchie
Emerging energy generation and storage technology by John MacRitchieEmerging energy generation and storage technology by John MacRitchie
Emerging energy generation and storage technology by John MacRitchieMaRS Discovery District
 
Combining different energy sources and uses by David Teichroeb
Combining different energy sources and uses by David TeichroebCombining different energy sources and uses by David Teichroeb
Combining different energy sources and uses by David TeichroebMaRS Discovery District
 
Combining different energy sources and uses by Joe Cargnelli
Combining different energy sources and uses by Joe CargnelliCombining different energy sources and uses by Joe Cargnelli
Combining different energy sources and uses by Joe CargnelliMaRS Discovery District
 
Combining different energy sources and uses by Murray McCaig
Combining different energy sources and uses by Murray McCaigCombining different energy sources and uses by Murray McCaig
Combining different energy sources and uses by Murray McCaigMaRS Discovery District
 
Designing the grid of the future by Ravi Seethapathy
Designing the grid of the future by Ravi SeethapathyDesigning the grid of the future by Ravi Seethapathy
Designing the grid of the future by Ravi SeethapathyMaRS Discovery District
 
Designing the grid of the future by Darren Finkbeiner
Designing the grid of the future by Darren FinkbeinerDesigning the grid of the future by Darren Finkbeiner
Designing the grid of the future by Darren FinkbeinerMaRS Discovery District
 
Designing the grid of the future by Stefan Kuppers
Designing the grid of the future by Stefan KuppersDesigning the grid of the future by Stefan Kuppers
Designing the grid of the future by Stefan KuppersMaRS Discovery District
 
Using the power of data by David Wollman
Using the power of data by David WollmanUsing the power of data by David Wollman
Using the power of data by David WollmanMaRS Discovery District
 
SR&ED: What you need to know about the changing landscape - MaRS Best Practices
SR&ED: What you need to know about the changing landscape - MaRS Best PracticesSR&ED: What you need to know about the changing landscape - MaRS Best Practices
SR&ED: What you need to know about the changing landscape - MaRS Best PracticesMaRS Discovery District
 

More from MaRS Discovery District (20)

Don Tapscott's New Solutions for a Connected Planet - MaRS Global Leadership
Don Tapscott's New Solutions for a Connected Planet - MaRS Global LeadershipDon Tapscott's New Solutions for a Connected Planet - MaRS Global Leadership
Don Tapscott's New Solutions for a Connected Planet - MaRS Global Leadership
 
Closing Remarks by Tom Rand
Closing Remarks by Tom RandClosing Remarks by Tom Rand
Closing Remarks by Tom Rand
 
Supporting the commercialization of new energy technology by Kaliyur Sridharan
Supporting the commercialization of new energy technology by Kaliyur SridharanSupporting the commercialization of new energy technology by Kaliyur Sridharan
Supporting the commercialization of new energy technology by Kaliyur Sridharan
 
Supporting the commercialization of new energy technology by Celine Bak
Supporting the commercialization of new energy technology by Celine BakSupporting the commercialization of new energy technology by Celine Bak
Supporting the commercialization of new energy technology by Celine Bak
 
Supporting the commercialization of new energy technology by Annette Verschuren
Supporting the commercialization of new energy technology by Annette VerschurenSupporting the commercialization of new energy technology by Annette Verschuren
Supporting the commercialization of new energy technology by Annette Verschuren
 
Emerging energy generation and storage technology by Ken Nakahara
Emerging energy generation and storage technology by Ken NakaharaEmerging energy generation and storage technology by Ken Nakahara
Emerging energy generation and storage technology by Ken Nakahara
 
Emerging energy generation and storage technology by Ted Sargent
Emerging energy generation and storage technology by Ted SargentEmerging energy generation and storage technology by Ted Sargent
Emerging energy generation and storage technology by Ted Sargent
 
Emerging energy generation and storage technology by Mark Tinkler
Emerging energy generation and storage technology by Mark TinklerEmerging energy generation and storage technology by Mark Tinkler
Emerging energy generation and storage technology by Mark Tinkler
 
Emerging energy generation and storage technology by John MacRitchie
Emerging energy generation and storage technology by John MacRitchieEmerging energy generation and storage technology by John MacRitchie
Emerging energy generation and storage technology by John MacRitchie
 
Lunch keynote by Minister Duguid
Lunch keynote by Minister DuguidLunch keynote by Minister Duguid
Lunch keynote by Minister Duguid
 
Combining different energy sources and uses by David Teichroeb
Combining different energy sources and uses by David TeichroebCombining different energy sources and uses by David Teichroeb
Combining different energy sources and uses by David Teichroeb
 
Combining different energy sources and uses by Joe Cargnelli
Combining different energy sources and uses by Joe CargnelliCombining different energy sources and uses by Joe Cargnelli
Combining different energy sources and uses by Joe Cargnelli
 
Combining different energy sources and uses by Murray McCaig
Combining different energy sources and uses by Murray McCaigCombining different energy sources and uses by Murray McCaig
Combining different energy sources and uses by Murray McCaig
 
Designing the grid of the future by Ravi Seethapathy
Designing the grid of the future by Ravi SeethapathyDesigning the grid of the future by Ravi Seethapathy
Designing the grid of the future by Ravi Seethapathy
 
Designing the grid of the future by Darren Finkbeiner
Designing the grid of the future by Darren FinkbeinerDesigning the grid of the future by Darren Finkbeiner
Designing the grid of the future by Darren Finkbeiner
 
Designing the grid of the future by Stefan Kuppers
Designing the grid of the future by Stefan KuppersDesigning the grid of the future by Stefan Kuppers
Designing the grid of the future by Stefan Kuppers
 
Using the power of data by David Wollman
Using the power of data by David WollmanUsing the power of data by David Wollman
Using the power of data by David Wollman
 
Introduction by ann cavoukian
Introduction by ann cavoukianIntroduction by ann cavoukian
Introduction by ann cavoukian
 
Introduction by ann cavoukian
Introduction by ann cavoukianIntroduction by ann cavoukian
Introduction by ann cavoukian
 
SR&ED: What you need to know about the changing landscape - MaRS Best Practices
SR&ED: What you need to know about the changing landscape - MaRS Best PracticesSR&ED: What you need to know about the changing landscape - MaRS Best Practices
SR&ED: What you need to know about the changing landscape - MaRS Best Practices
 

Recently uploaded

Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
Best VIP Call Girls Noida Sector 40 Call Me: 8448380779Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
Best VIP Call Girls Noida Sector 40 Call Me: 8448380779Delhi Call girls
 
Unlocking the Secrets of Affiliate Marketing.pdf
Unlocking the Secrets of Affiliate Marketing.pdfUnlocking the Secrets of Affiliate Marketing.pdf
Unlocking the Secrets of Affiliate Marketing.pdfOnline Income Engine
 
Event mailer assignment progress report .pdf
Event mailer assignment progress report .pdfEvent mailer assignment progress report .pdf
Event mailer assignment progress report .pdftbatkhuu1
 
Keppel Ltd. 1Q 2024 Business Update Presentation Slides
Keppel Ltd. 1Q 2024 Business Update Presentation SlidesKeppel Ltd. 1Q 2024 Business Update Presentation Slides
Keppel Ltd. 1Q 2024 Business Update Presentation SlidesKeppelCorporation
 
Lucknow đź’‹ Escorts in Lucknow - 450+ Call Girl Cash Payment 8923113531 Neha Th...
Lucknow đź’‹ Escorts in Lucknow - 450+ Call Girl Cash Payment 8923113531 Neha Th...Lucknow đź’‹ Escorts in Lucknow - 450+ Call Girl Cash Payment 8923113531 Neha Th...
Lucknow đź’‹ Escorts in Lucknow - 450+ Call Girl Cash Payment 8923113531 Neha Th...anilsa9823
 
Grateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdfGrateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdfPaul Menig
 
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best Services
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best ServicesMysore Call Girls 8617370543 WhatsApp Number 24x7 Best Services
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best ServicesDipal Arora
 
Regression analysis: Simple Linear Regression Multiple Linear Regression
Regression analysis: Simple Linear Regression Multiple Linear RegressionRegression analysis: Simple Linear Regression Multiple Linear Regression
Regression analysis: Simple Linear Regression Multiple Linear RegressionRavindra Nath Shukla
 
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With Room
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With RoomVIP Kolkata Call Girl Howrah 👉 8250192130 Available With Room
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With Roomdivyansh0kumar0
 
Understanding the Pakistan Budgeting Process: Basics and Key Insights
Understanding the Pakistan Budgeting Process: Basics and Key InsightsUnderstanding the Pakistan Budgeting Process: Basics and Key Insights
Understanding the Pakistan Budgeting Process: Basics and Key Insightsseribangash
 
Forklift Operations: Safety through Cartoons
Forklift Operations: Safety through CartoonsForklift Operations: Safety through Cartoons
Forklift Operations: Safety through CartoonsForklift Trucks in Minnesota
 
Monthly Social Media Update April 2024 pptx.pptx
Monthly Social Media Update April 2024 pptx.pptxMonthly Social Media Update April 2024 pptx.pptx
Monthly Social Media Update April 2024 pptx.pptxAndy Lambert
 
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 
Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...
Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...
Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...Dave Litwiller
 
Value Proposition canvas- Customer needs and pains
Value Proposition canvas- Customer needs and painsValue Proposition canvas- Customer needs and pains
Value Proposition canvas- Customer needs and painsP&CO
 
HONOR Veterans Event Keynote by Michael Hawkins
HONOR Veterans Event Keynote by Michael HawkinsHONOR Veterans Event Keynote by Michael Hawkins
HONOR Veterans Event Keynote by Michael HawkinsMichael W. Hawkins
 
Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023Neil Kimberley
 
Monte Carlo simulation : Simulation using MCSM
Monte Carlo simulation : Simulation using MCSMMonte Carlo simulation : Simulation using MCSM
Monte Carlo simulation : Simulation using MCSMRavindra Nath Shukla
 

Recently uploaded (20)

Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
Best VIP Call Girls Noida Sector 40 Call Me: 8448380779Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
Best VIP Call Girls Noida Sector 40 Call Me: 8448380779
 
Unlocking the Secrets of Affiliate Marketing.pdf
Unlocking the Secrets of Affiliate Marketing.pdfUnlocking the Secrets of Affiliate Marketing.pdf
Unlocking the Secrets of Affiliate Marketing.pdf
 
Event mailer assignment progress report .pdf
Event mailer assignment progress report .pdfEvent mailer assignment progress report .pdf
Event mailer assignment progress report .pdf
 
Keppel Ltd. 1Q 2024 Business Update Presentation Slides
Keppel Ltd. 1Q 2024 Business Update Presentation SlidesKeppel Ltd. 1Q 2024 Business Update Presentation Slides
Keppel Ltd. 1Q 2024 Business Update Presentation Slides
 
Lucknow đź’‹ Escorts in Lucknow - 450+ Call Girl Cash Payment 8923113531 Neha Th...
Lucknow đź’‹ Escorts in Lucknow - 450+ Call Girl Cash Payment 8923113531 Neha Th...Lucknow đź’‹ Escorts in Lucknow - 450+ Call Girl Cash Payment 8923113531 Neha Th...
Lucknow đź’‹ Escorts in Lucknow - 450+ Call Girl Cash Payment 8923113531 Neha Th...
 
Grateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdfGrateful 7 speech thanking everyone that has helped.pdf
Grateful 7 speech thanking everyone that has helped.pdf
 
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best Services
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best ServicesMysore Call Girls 8617370543 WhatsApp Number 24x7 Best Services
Mysore Call Girls 8617370543 WhatsApp Number 24x7 Best Services
 
Regression analysis: Simple Linear Regression Multiple Linear Regression
Regression analysis: Simple Linear Regression Multiple Linear RegressionRegression analysis: Simple Linear Regression Multiple Linear Regression
Regression analysis: Simple Linear Regression Multiple Linear Regression
 
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With Room
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With RoomVIP Kolkata Call Girl Howrah 👉 8250192130 Available With Room
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With Room
 
Understanding the Pakistan Budgeting Process: Basics and Key Insights
Understanding the Pakistan Budgeting Process: Basics and Key InsightsUnderstanding the Pakistan Budgeting Process: Basics and Key Insights
Understanding the Pakistan Budgeting Process: Basics and Key Insights
 
Forklift Operations: Safety through Cartoons
Forklift Operations: Safety through CartoonsForklift Operations: Safety through Cartoons
Forklift Operations: Safety through Cartoons
 
Monthly Social Media Update April 2024 pptx.pptx
Monthly Social Media Update April 2024 pptx.pptxMonthly Social Media Update April 2024 pptx.pptx
Monthly Social Media Update April 2024 pptx.pptx
 
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Pune Just Call 9907093804 Top Class Call Girl Service Available
 
Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...
Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...
Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...
 
Value Proposition canvas- Customer needs and pains
Value Proposition canvas- Customer needs and painsValue Proposition canvas- Customer needs and pains
Value Proposition canvas- Customer needs and pains
 
HONOR Veterans Event Keynote by Michael Hawkins
HONOR Veterans Event Keynote by Michael HawkinsHONOR Veterans Event Keynote by Michael Hawkins
HONOR Veterans Event Keynote by Michael Hawkins
 
Nepali Escort Girl Kakori \ 9548273370 Indian Call Girls Service Lucknow â‚ą,9517
Nepali Escort Girl Kakori \ 9548273370 Indian Call Girls Service Lucknow â‚ą,9517Nepali Escort Girl Kakori \ 9548273370 Indian Call Girls Service Lucknow â‚ą,9517
Nepali Escort Girl Kakori \ 9548273370 Indian Call Girls Service Lucknow â‚ą,9517
 
Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023Mondelez State of Snacking and Future Trends 2023
Mondelez State of Snacking and Future Trends 2023
 
Monte Carlo simulation : Simulation using MCSM
Monte Carlo simulation : Simulation using MCSMMonte Carlo simulation : Simulation using MCSM
Monte Carlo simulation : Simulation using MCSM
 
VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...
VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...
VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...
 

Quality and Regulatory Affairs

  • 1. Regulatory IND Process James Ault, RAC, RQAP-GLP VP Quality and Regulatory Affairs Ricerca Biosciences, LLC May 23, 2007 Quality and Regulatory Affairs
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18. What is cGMP? Good Manufacturing Practices Shipping/Receiving Raw Mats/Supplies Quarantine-Test-Release Processing - batch records Validated facilities/equip. Good documentation Test product Documentation reviewed by QA - Release/Reject Label and ship to client Archive data and records Wait for FDA to appear
  • 19.
  • 20.
  • 21.
  • 22. What is GLP? Good Laboratory Practices Adequate Facility Qualified Personnel - Technical and Quality Unit Protocol and SD Unique Suitable Test Systems Characterized Test Materials/Controls Effective SOPs Accurate/Timely Data Accurate/Complete Report Secure Archives
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.