13 Ondqa PPTs View free & download

ONDQA Perspective on Post Approval Changes PowerPoint PPT Presentation

ONDQA Perspective on Post Approval Changes - ONDQA Perspective on Post Approval Changes. Eric P. Duffy, PhD ... Public Meeting: Supplements and Other Changes to an Approved Application ...

ONDQA Perspective on Post Approval Changes. Eric P. Duffy, PhD ... Public Meeting: Supplements and Other Changes to an Approved Application ...

| PowerPoint PPT presentation | free to view

Implementation of Quality-by-Design: ONDQA Initiatives PowerPoint PPT Presentation

Implementation of Quality-by-Design: ONDQA Initiatives - Enables FDA to provide regulatory flexibility for specification setting and post ... Degree of flexibility granted would depend on level of knowledge and ...

Enables FDA to provide regulatory flexibility for specification setting and post ... Degree of flexibility granted would depend on level of knowledge and ...

| PowerPoint PPT presentation | free to view

Implementation of Quality by Design (QbD): Status, Challenges and Next Steps PowerPoint PPT Presentation

Implementation of Quality by Design (QbD): Status, Challenges and Next Steps - Office of New Drug Quality Assessment (ONDQA), OPS, CDER ... A maximally efficient, agile, flexible pharmaceutical manufacturing sector that ...

Office of New Drug Quality Assessment (ONDQA), OPS, CDER ... A maximally efficient, agile, flexible pharmaceutical manufacturing sector that ...

| PowerPoint PPT presentation | free to view

Role of Statistics in Pharmaceutical Development Using Quality-by-Design Approach PowerPoint PPT Presentation

Role of Statistics in Pharmaceutical Development Using Quality-by-Design Approach - Role of Statistics in Pharmaceutical Development Using Quality-by-Design Approach an FDA Perspective Chi-wan Chen, Ph.D. Christine Moore, Ph.D.

Role of Statistics in Pharmaceutical Development Using Quality-by-Design Approach an FDA Perspective Chi-wan Chen, Ph.D. Christine Moore, Ph.D.

| PowerPoint PPT presentation | free to view

Role of Statistics in Pharmaceutical Development Using Quality-by-Design Approach - Role of Statistics in Pharmaceutical Development Using QualitybyDesign Approach an FDA Perspective

Role of Statistics in Pharmaceutical Development Using QualitybyDesign Approach an FDA Perspective

| PowerPoint PPT presentation | free to view

Implementation of Revised Topical Dosage Form Definitions PowerPoint PPT Presentation

Implementation of Revised Topical Dosage Form Definitions - Implementation of Revised Topical Dosage Form Definitions Lucinda (Cindy) Buhse, Ph.D. Director, Division of Pharmaceutical Analysis Since October 2003 Advisory ...

Implementation of Revised Topical Dosage Form Definitions Lucinda (Cindy) Buhse, Ph.D. Director, Division of Pharmaceutical Analysis Since October 2003 Advisory ...

| PowerPoint PPT presentation | free to download

Department of Health and Human Services DHHS Food and Drug Administration FDA Center for Drug Evalua PowerPoint PPT Presentation

Department of Health and Human Services DHHS Food and Drug Administration FDA Center for Drug Evalua - Department of Health and Human Services (DHHS) Food and Drug Administration (FDA) ... ( Section 506C of the Food, Drug , and Cosmetic Act) ...

Department of Health and Human Services (DHHS) Food and Drug Administration (FDA) ... ( Section 506C of the Food, Drug , and Cosmetic Act) ...

| PowerPoint PPT presentation | free to view

Advisory Committee for Pharmaceutical Science October 25-26, 2005 PowerPoint PPT Presentation

Advisory Committee for Pharmaceutical Science October 25-26, 2005 - We have no preconceived thoughts on how products need to be developed and ... in our thinking and not have preconceived ideas as to how follow-ons should be regulated ...

We have no preconceived thoughts on how products need to be developed and ... in our thinking and not have preconceived ideas as to how follow-ons should be regulated ...

| PowerPoint PPT presentation | free to download

ICH Quality Topics Update PowerPoint PPT Presentation

ICH Quality Topics Update - The International Conference of Harmonisation of Technical Requirements for the ... A harmonized pharmaceutical quality system applicable across the life cycle of ...

The International Conference of Harmonisation of Technical Requirements for the ... A harmonized pharmaceutical quality system applicable across the life cycle of ...

| PowerPoint PPT presentation | free to view

Application of QbD Principles for Biotech PowerPoint PPT Presentation

Application of QbD Principles for Biotech - Mouse. Chimeric. Human. Humanized. Overview. Definitions. Relevant Product Attributes ... Harvest. Proteolytic Steps. Diafilt./Conc. Lyophilization ...

Mouse. Chimeric. Human. Humanized. Overview. Definitions. Relevant Product Attributes ... Harvest. Proteolytic Steps. Diafilt./Conc. Lyophilization ...

| PowerPoint PPT presentation | free to view

Perspectives on New Paradigms of Risk and Compliance in Pharmaceutical Development: Quality by Design, PAT, and Design Space PowerPoint PPT Presentation

Perspectives on New Paradigms of Risk and Compliance in Pharmaceutical Development: Quality by Design, PAT, and Design Space - ... over the activities of chemistry, ... Demonstrate quality in internal systems and activities ... FDA is cosponsoring event on October 17-18 in Reston, VA ...

... over the activities of chemistry, ... Demonstrate quality in internal systems and activities ... FDA is cosponsoring event on October 17-18 in Reston, VA ...

| PowerPoint PPT presentation | free to download

CMC Considerations for the Fixeddose Combination Drugs Ravi S. Harapanhalli, Ph.D. Chief, CMC Branch PowerPoint PPT Presentation

CMC Considerations for the Fixeddose Combination Drugs Ravi S. Harapanhalli, Ph.D. Chief, CMC Branch - Lorcer-HD, Hydrocet (hydrocodone bitartrate 5 mg and acetaminophen 500 mg) Oral solutions (hydrocodone 5-10 mg, and acetaminophen 325 750 mg) ...

Lorcer-HD, Hydrocet (hydrocodone bitartrate 5 mg and acetaminophen 500 mg) Oral solutions (hydrocodone 5-10 mg, and acetaminophen 325 750 mg) ...

| PowerPoint PPT presentation | free to view

Role of Statistics in Pharmaceutical Development Using QualitybyDesign Approach an FDA Perspective PowerPoint PPT Presentation

Role of Statistics in Pharmaceutical Development Using QualitybyDesign Approach an FDA Perspective - Critical sources of process variability are identified and controlled ... participating firms to submit CMC information based on QbD. FDA to implement Q8, Q9, ...

Critical sources of process variability are identified and controlled ... participating firms to submit CMC information based on QbD. FDA to implement Q8, Q9, ...

| PowerPoint PPT presentation | free to view

Ondqa PowerPoint PPT Presentations