SlideShare a Scribd company logo
Discussion Forum on ICH Q7 & Q11
Interactive Opening Discussion
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
23 April 2017 (Program A)
21 May 2017 (Program B)
Interactive Opening Discussion
Q7 Q11
Ingredients Process Product
Can a drug product manufactured from a
non-compliant API ensure safety???
SM IM API Excipients
Capsule
shell
Is GMP required? Yes / No
ICHQ7 & Q11 (2 of 7)

More Related Content

What's hot

Stabicon-Corporate presentation
Stabicon-Corporate presentationStabicon-Corporate presentation
Stabicon-Corporate presentation
Stabicon Life Sciences Pvt. Ltd
 
Kyle Jordan resume 4-27
Kyle Jordan resume 4-27Kyle Jordan resume 4-27
Kyle Jordan resume 4-27
Kyle Jordan
 
Paper Presentation on ISO/IEC 17025:2017 at Labtech2017
Paper Presentation on ISO/IEC 17025:2017 at Labtech2017Paper Presentation on ISO/IEC 17025:2017 at Labtech2017
Paper Presentation on ISO/IEC 17025:2017 at Labtech2017
Global Manager Group
 
ISO/IEC 17025:2017 Training ppt
ISO/IEC 17025:2017 Training pptISO/IEC 17025:2017 Training ppt
ISO/IEC 17025:2017 Training ppt
Global Manager Group
 
harold_cv052015
harold_cv052015harold_cv052015
harold_cv052015
Harold emordi
 
2 OARO-Interactive Discusion-04 Feb 2017
2  OARO-Interactive Discusion-04 Feb 20172  OARO-Interactive Discusion-04 Feb 2017
2 OARO-Interactive Discusion-04 Feb 2017
Obaid Ali / Roohi B. Obaid
 
4 OARO-Case Studies-04 Feb 2017
4  OARO-Case Studies-04 Feb 20174  OARO-Case Studies-04 Feb 2017
4 OARO-Case Studies-04 Feb 2017
Obaid Ali / Roohi B. Obaid
 
ARRA NAMPALLY CV
ARRA NAMPALLY CVARRA NAMPALLY CV
ARRA NAMPALLY CV
arra nampally
 
QIC Inc.- Your Global Solutions Partner
QIC Inc.- Your Global Solutions PartnerQIC Inc.- Your Global Solutions Partner
QIC Inc.- Your Global Solutions Partner
Tami Mulinix
 
5 OARO-Inspector's Eye -04 Feb 2017
5  OARO-Inspector's Eye -04 Feb 20175  OARO-Inspector's Eye -04 Feb 2017
5 OARO-Inspector's Eye -04 Feb 2017
Obaid Ali / Roohi B. Obaid
 
ISO/IEC 17025:2017: Structural Requirements
ISO/IEC 17025:2017: Structural RequirementsISO/IEC 17025:2017: Structural Requirements
ISO/IEC 17025:2017: Structural Requirements
Cal Lab Access
 
Mark Pittman Qualification and Validation Resume
Mark Pittman Qualification and Validation ResumeMark Pittman Qualification and Validation Resume
Mark Pittman Qualification and Validation Resume
Mark Pittman
 
Ce Brochure
Ce BrochureCe Brochure
Ce Brochure
SCS universal
 
Specific Detailed Changes to the New ISO 13485:2016
Specific Detailed Changes to the New ISO 13485:2016Specific Detailed Changes to the New ISO 13485:2016
Specific Detailed Changes to the New ISO 13485:2016
Greenlight Guru
 
Kellie whiteresume
Kellie whiteresumeKellie whiteresume
Kellie whiteresume
Michael Kellie White
 

What's hot (15)

Stabicon-Corporate presentation
Stabicon-Corporate presentationStabicon-Corporate presentation
Stabicon-Corporate presentation
 
Kyle Jordan resume 4-27
Kyle Jordan resume 4-27Kyle Jordan resume 4-27
Kyle Jordan resume 4-27
 
Paper Presentation on ISO/IEC 17025:2017 at Labtech2017
Paper Presentation on ISO/IEC 17025:2017 at Labtech2017Paper Presentation on ISO/IEC 17025:2017 at Labtech2017
Paper Presentation on ISO/IEC 17025:2017 at Labtech2017
 
ISO/IEC 17025:2017 Training ppt
ISO/IEC 17025:2017 Training pptISO/IEC 17025:2017 Training ppt
ISO/IEC 17025:2017 Training ppt
 
harold_cv052015
harold_cv052015harold_cv052015
harold_cv052015
 
2 OARO-Interactive Discusion-04 Feb 2017
2  OARO-Interactive Discusion-04 Feb 20172  OARO-Interactive Discusion-04 Feb 2017
2 OARO-Interactive Discusion-04 Feb 2017
 
4 OARO-Case Studies-04 Feb 2017
4  OARO-Case Studies-04 Feb 20174  OARO-Case Studies-04 Feb 2017
4 OARO-Case Studies-04 Feb 2017
 
ARRA NAMPALLY CV
ARRA NAMPALLY CVARRA NAMPALLY CV
ARRA NAMPALLY CV
 
QIC Inc.- Your Global Solutions Partner
QIC Inc.- Your Global Solutions PartnerQIC Inc.- Your Global Solutions Partner
QIC Inc.- Your Global Solutions Partner
 
5 OARO-Inspector's Eye -04 Feb 2017
5  OARO-Inspector's Eye -04 Feb 20175  OARO-Inspector's Eye -04 Feb 2017
5 OARO-Inspector's Eye -04 Feb 2017
 
ISO/IEC 17025:2017: Structural Requirements
ISO/IEC 17025:2017: Structural RequirementsISO/IEC 17025:2017: Structural Requirements
ISO/IEC 17025:2017: Structural Requirements
 
Mark Pittman Qualification and Validation Resume
Mark Pittman Qualification and Validation ResumeMark Pittman Qualification and Validation Resume
Mark Pittman Qualification and Validation Resume
 
Ce Brochure
Ce BrochureCe Brochure
Ce Brochure
 
Specific Detailed Changes to the New ISO 13485:2016
Specific Detailed Changes to the New ISO 13485:2016Specific Detailed Changes to the New ISO 13485:2016
Specific Detailed Changes to the New ISO 13485:2016
 
Kellie whiteresume
Kellie whiteresumeKellie whiteresume
Kellie whiteresume
 

More from Hubdar Ali

List of Provisional Registered Participants
List of Provisional Registered Participants List of Provisional Registered Participants
List of Provisional Registered Participants
Hubdar Ali
 
List of Registered Participants
List of Registered Participants  List of Registered Participants
List of Registered Participants
Hubdar Ali
 
List of CRP's (ICH-Q9)
List of CRP's  (ICH-Q9)List of CRP's  (ICH-Q9)
List of CRP's (ICH-Q9)
Hubdar Ali
 
List of-registered-applicants-updated
List of-registered-applicants-updatedList of-registered-applicants-updated
List of-registered-applicants-updated
Hubdar Ali
 
Opening of Discussion Forum 21 May 2017
Opening of Discussion Forum 21 May 2017Opening of Discussion Forum 21 May 2017
Opening of Discussion Forum 21 May 2017
Hubdar Ali
 
ICHQ7 & Q11 (6 of 7)
ICHQ7 & Q11 (6 of 7)ICHQ7 & Q11 (6 of 7)
ICHQ7 & Q11 (6 of 7)
Hubdar Ali
 
List of Registered Participants (program b)
List of Registered Participants (program b)List of Registered Participants (program b)
List of Registered Participants (program b)
Hubdar Ali
 
Position Paper
Position PaperPosition Paper
Position Paper
Hubdar Ali
 

More from Hubdar Ali (8)

List of Provisional Registered Participants
List of Provisional Registered Participants List of Provisional Registered Participants
List of Provisional Registered Participants
 
List of Registered Participants
List of Registered Participants  List of Registered Participants
List of Registered Participants
 
List of CRP's (ICH-Q9)
List of CRP's  (ICH-Q9)List of CRP's  (ICH-Q9)
List of CRP's (ICH-Q9)
 
List of-registered-applicants-updated
List of-registered-applicants-updatedList of-registered-applicants-updated
List of-registered-applicants-updated
 
Opening of Discussion Forum 21 May 2017
Opening of Discussion Forum 21 May 2017Opening of Discussion Forum 21 May 2017
Opening of Discussion Forum 21 May 2017
 
ICHQ7 & Q11 (6 of 7)
ICHQ7 & Q11 (6 of 7)ICHQ7 & Q11 (6 of 7)
ICHQ7 & Q11 (6 of 7)
 
List of Registered Participants (program b)
List of Registered Participants (program b)List of Registered Participants (program b)
List of Registered Participants (program b)
 
Position Paper
Position PaperPosition Paper
Position Paper
 

Recently uploaded

Designing and Sustaining Large-Scale Value-Centered Agile Ecosystems (powered...
Designing and Sustaining Large-Scale Value-Centered Agile Ecosystems (powered...Designing and Sustaining Large-Scale Value-Centered Agile Ecosystems (powered...
Designing and Sustaining Large-Scale Value-Centered Agile Ecosystems (powered...
Alexey Krivitsky
 
Stuart Wilson the teams I have led - 2024
Stuart Wilson the teams I have led - 2024Stuart Wilson the teams I have led - 2024
Stuart Wilson the teams I have led - 2024
stuwilson.co.uk
 
Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...
Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...
Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...
dsnow9802
 
Conflict resololution,role of hr in resolution
Conflict resololution,role of hr in resolutionConflict resololution,role of hr in resolution
Conflict resololution,role of hr in resolution
Dr. Christine Ngari ,Ph.D (HRM)
 
Addiction to Winning Across Diverse Populations.pdf
Addiction to Winning Across Diverse Populations.pdfAddiction to Winning Across Diverse Populations.pdf
Addiction to Winning Across Diverse Populations.pdf
Bill641377
 
Impact of Effective Performance Appraisal Systems on Employee Motivation and ...
Impact of Effective Performance Appraisal Systems on Employee Motivation and ...Impact of Effective Performance Appraisal Systems on Employee Motivation and ...
Impact of Effective Performance Appraisal Systems on Employee Motivation and ...
Dr. Nazrul Islam
 
All the Small Things - XP2024 Bolzano/Bozen
All the Small Things - XP2024 Bolzano/BozenAll the Small Things - XP2024 Bolzano/Bozen
All the Small Things - XP2024 Bolzano/Bozen
Alberto Brandolini
 
Team Building and TUCKMANS MODEL Explained
Team Building and TUCKMANS MODEL ExplainedTeam Building and TUCKMANS MODEL Explained
Team Building and TUCKMANS MODEL Explained
iampriyanshujaiswal
 
Chart--Time Management.pdf How to time is spent
Chart--Time Management.pdf How to time is spentChart--Time Management.pdf How to time is spent
Chart--Time Management.pdf How to time is spent
spandane
 
12 steps to transform your organization into the agile org you deserve
12 steps to transform your organization into the agile org you deserve12 steps to transform your organization into the agile org you deserve
12 steps to transform your organization into the agile org you deserve
Pierre E. NEIS
 
The Management Guide: From Projects to Portfolio
The Management Guide: From Projects to PortfolioThe Management Guide: From Projects to Portfolio
The Management Guide: From Projects to Portfolio
Ahmed AbdelMoneim
 
一比一原版(QU毕业证)皇后大学毕业证如何办理
一比一原版(QU毕业证)皇后大学毕业证如何办理一比一原版(QU毕业证)皇后大学毕业证如何办理
一比一原版(QU毕业证)皇后大学毕业证如何办理
8p28uk6g
 
innovation in nursing practice, education and management.pptx
innovation in nursing practice, education and management.pptxinnovation in nursing practice, education and management.pptx
innovation in nursing practice, education and management.pptx
TulsiDhidhi1
 
Ganpati Kumar Choudhary Indian Ethos PPT.pptx
Ganpati Kumar Choudhary Indian Ethos PPT.pptxGanpati Kumar Choudhary Indian Ethos PPT.pptx
Ganpati Kumar Choudhary Indian Ethos PPT.pptx
GanpatiKumarChoudhar
 

Recently uploaded (14)

Designing and Sustaining Large-Scale Value-Centered Agile Ecosystems (powered...
Designing and Sustaining Large-Scale Value-Centered Agile Ecosystems (powered...Designing and Sustaining Large-Scale Value-Centered Agile Ecosystems (powered...
Designing and Sustaining Large-Scale Value-Centered Agile Ecosystems (powered...
 
Stuart Wilson the teams I have led - 2024
Stuart Wilson the teams I have led - 2024Stuart Wilson the teams I have led - 2024
Stuart Wilson the teams I have led - 2024
 
Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...
Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...
Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...
 
Conflict resololution,role of hr in resolution
Conflict resololution,role of hr in resolutionConflict resololution,role of hr in resolution
Conflict resololution,role of hr in resolution
 
Addiction to Winning Across Diverse Populations.pdf
Addiction to Winning Across Diverse Populations.pdfAddiction to Winning Across Diverse Populations.pdf
Addiction to Winning Across Diverse Populations.pdf
 
Impact of Effective Performance Appraisal Systems on Employee Motivation and ...
Impact of Effective Performance Appraisal Systems on Employee Motivation and ...Impact of Effective Performance Appraisal Systems on Employee Motivation and ...
Impact of Effective Performance Appraisal Systems on Employee Motivation and ...
 
All the Small Things - XP2024 Bolzano/Bozen
All the Small Things - XP2024 Bolzano/BozenAll the Small Things - XP2024 Bolzano/Bozen
All the Small Things - XP2024 Bolzano/Bozen
 
Team Building and TUCKMANS MODEL Explained
Team Building and TUCKMANS MODEL ExplainedTeam Building and TUCKMANS MODEL Explained
Team Building and TUCKMANS MODEL Explained
 
Chart--Time Management.pdf How to time is spent
Chart--Time Management.pdf How to time is spentChart--Time Management.pdf How to time is spent
Chart--Time Management.pdf How to time is spent
 
12 steps to transform your organization into the agile org you deserve
12 steps to transform your organization into the agile org you deserve12 steps to transform your organization into the agile org you deserve
12 steps to transform your organization into the agile org you deserve
 
The Management Guide: From Projects to Portfolio
The Management Guide: From Projects to PortfolioThe Management Guide: From Projects to Portfolio
The Management Guide: From Projects to Portfolio
 
一比一原版(QU毕业证)皇后大学毕业证如何办理
一比一原版(QU毕业证)皇后大学毕业证如何办理一比一原版(QU毕业证)皇后大学毕业证如何办理
一比一原版(QU毕业证)皇后大学毕业证如何办理
 
innovation in nursing practice, education and management.pptx
innovation in nursing practice, education and management.pptxinnovation in nursing practice, education and management.pptx
innovation in nursing practice, education and management.pptx
 
Ganpati Kumar Choudhary Indian Ethos PPT.pptx
Ganpati Kumar Choudhary Indian Ethos PPT.pptxGanpati Kumar Choudhary Indian Ethos PPT.pptx
Ganpati Kumar Choudhary Indian Ethos PPT.pptx
 

ICHQ7 & Q11 (2 of 7)