CDER Office of Compliance Priorities and focus
|
|
|
- Alisha Rogers
- 6 years ago
- Views:
Transcription
1 CDER Office of Compliance Priorities and focus ILISA B.G. BERNSTEIN, Pharm.D., J.D. Deputy Director, Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration Pharmaceutical Compliance Congress Conference Washington DC, January 29, 2014
2 CDER Office of Compliance Office of Compliance Office of Drug Security, Integrity and Recalls Office of Manufacturing and Product Quality Office of Scientific Investigations Office of Unapproved Drugs and Labeling Compliance 2
3 What s we ve been up to.. Quality initiatives Food and Drug Administration Safety and Innovation Act (FDASIA) implementation Drug Quality and Security Act (DQSA) Compounding (Title I) Supply chain integrity (Title II) Global focus Compliance and enforcement actions.among other things!! 3
4 Quality initiatives Improved overall approach to regulating pharmaceutical quality Comprehensive approach Planning to make coordinated organizational, process, and policy changes that will move us more towards the new vision NEW Office of Pharmaceutical Quality (OPQ) Principles for change: Clinically relevant standards Lifecycle approach and integrated review/inspection Clear enforcement policies Surveillance using quality metrics 4
5 Additional quality initiatives Increase focus on contracting Quality agreements draft guidance Promoting modernization and innovation (collaborations, continuous manufacturing, etc.) Shortage prevention and mitigation 5
6 Drug shortages: Strategic plan First strategy is to strengthen FDA response Streamlining internal processes Improving data tracking Better communication including targeted communication Second strategy is to implement new efforts to prevent quality issues from occurring Exploring incentives for manufacturers Creation of a new Office of Pharmaceutical Quality Working to develop ways to identify early warning signals at manufacturers Working with outside stakeholders to better understand the range of factors that contribute to shortages 1/31/ CDER Drug Shortages
7 Drug shortages: What s needed? Must have industry commitment to culture of quality manufacturing Many firms are building new plants Need better manufacturing practices, methods and quality testing Need more production redundancy Promptly report and correct even small production and quality problems 1/31/ CDER Drug Shortages
8 FDASIA Implementation PDUFA V (Title I) GDUFA (Title III) Drug Supply Chain (Title VII) Drug Shortages (Title X) 8
9 FDASIA Title VII Drug Supply Chain Increased Risk Information Registration (foreign & domestic) Excipient information Interoperable electronic systems Information exchange Standards of admission for imported drugs Registration of commercial importers Notification Global Supply Chain Risk-based inspections Records for inspection Recognizing foreign govt. inspections Enhancing safety and quality of drug supply / quality management sytems Enhanced Tools Administrative destruction Prohibit inspectional delay, limitation, denial, refusal Administrative detention Protection against intentional adulteration Penalties for counterfeiting drugs Extraterritorial jurisdiction 9
10 New Drug Supply Chain Security Act (Track and Trace) Outlines steps to build an electronic, interoperable system to identify and trace certain Rx drugs as they are distributed in the U.S. Product identification Product tracing Product verification Detection and response Notification Wholesaler (WDD) licensing/standards Third-party logistics provider licensing/standards Enhanced system 10 years Penalties National uniform policy 10
11 Supply chain integrity Secure supply chain pilot Program for expediting the importation of APIs and drug products into the US 2-year pilot program, from Feb 2014 through Feb 2016 Tackling new distribution scheme of counterfeits/unapproved drugs to doctors/clinics Outreach letters were sent to over 1,500 Medical Clinics/Doctors to educate them on avoiding counterfeit and unapproved drug purchases. 11
12 12
13 13
14 Global focus Observational/Joint inspections GMP, GCP, BE PIC/S Pharmaceutical Inspection Cooperation Scheme ICH International Conference on Harmonization APEC Asia Pacific Economic Cooperation Supply chain integrity roadmap WHO World Health Organization Others. 14
15 Other compliance and enforcement activities. CGMP Program Post Marketing Requirements (PMR) Enforcement Program Homeopathic drug products Unapproved marketed drugs initiative Data integrity More.. 15
16 What s next???? Quality initiatives FDASIA DQSA Compounding Supply chain integrity International collaborations Compliance and enforcement actions.among other things!! 16
17 Thank you!!! ILISA B.G. BERNSTEIN, Pharm.D., J.D. FDA/CDER/Office of Compliance 17 17
Drug Supply Chain Security Act Implementation Track and Trace Issues in 2017
Drug Supply Chain Security Act Implementation Track and Trace Issues in 2017 ILISA BG BERNSTEIN, PharmD, JD Deputy Director, Office of Compliance FDA/CDER Presented at: FDLI DQSA Conference November 15,
CDER /OPQ Office of Surveillance Quality Metrics in Surveillance
CDER /OPQ Office of Surveillance Quality Metrics in Surveillance Russell Wesdyk Acting Director Office of Surveillance Office of Surveillance Goals Builds from the shared vision A maximally efficient,
CDER 2016 Actions and 2017 Priorities. Richard Moscicki Deputy Center Director for Science Operations, CDER, FDA
CDER 2016 Actions and 2017 Priorities Richard Moscicki Deputy Center Director for Science Operations, CDER, FDA Disclosure My comments today are mine and do not necessarily represent the views of the US
IVT Laboratory Week Jerry Lanese. Ph.D. The Lanese Group, Inc The Lanese Group, Inc.
IVT Laboratory Week-2015 Jerry Lanese Ph.D. The Lanese Group, Inc. 1 Name Job What brought you here. 2 FDA interest in Quality Metrics What are Quality Metrics Quality metrics FDA will request The impact
EU and FDA GMP Regulations: Overview and Comparison
THE QUALITY ASSURANCE JOURNAL, VOL. 2, 55 60 (1997) EU and FDA GMP Regulations: Overview and Comparison The increasing emphasis on global supply of drug products, as well as starting materials and investigational
Section I: Pharmaceuticals and Medical Devices
SUPPLEMENT on HEALTHCARE INNOVATION Visionary Goals and Recommendations 51th Japan-U.S. Business Conference Japan-U.S. Business Council / U.S.-Japan Business Council November 14, 2014 The R&D-based pharmaceutical
ICH Q8/Q8(R)
Pharmaceutical Quality for the 21 st Century Temple University May 06, 2008 Joseph Famulare, Deputy Director FDA CDER Office of Compliance CDER Office of Compliance and the Critical Path Initiative Since
Pharmaceutical Quality for 21 st Century Initiative
Quality Metrics Alicia Mozzachio, RPh, MPH Senior Advisor for International Activities Office of Policy for Pharmaceutical Quality (OPPQ) Center for Drug Evaluation and Research U.S. Food and Drug Administration
Validation and Verification of Supply Chain: End-to-End Karen S Ginsbury For IVT: Workshop C 28 October :30 12:00
Validation and Verification of Supply Chain: End-to-End Karen S Ginsbury For IVT: Workshop C 28 October 2014 08:30 12:00 Pangea 7 May 2014 Israel ONLY Pangea 7 May 2014 Israel ONLY Pangea 7 May 2014 Israel
How Pharma Should Monitor itself for GMP Compliance & How FDA Inspections Could Incorporate Pharmaceutical Inspection Cooperation Scheme (PIC/S)
How Pharma Should Monitor itself for GMP Compliance & How FDA Inspections Could Incorporate Pharmaceutical Inspection Cooperation Scheme (PIC/S) ASQ Northeast Pharmaceutical GMP/Quality Conference January
Overview of FDA Regulations and Guidance Documents related to PET Drug Chemistry. Steve Zigler, Ph.D. Siemens PETNET Solutions
Overview of FDA Regulations and Guidance Documents related to PET Drug Chemistry Steve Zigler, Ph.D. Siemens PETNET Solutions Employee of Siemens-PETNET Solutions I will not discuss investigational agents,
Quality Agreements with CMO s. Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals
Quality Agreements with CMO s Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals FDA Guidance Contract Manufacturing Arrangements for Drugs: Quality
FDA Quality Metrics Guidance
FDA Quality Metrics Guidance Marlène García Swider, Ph.D., CQM, CSSBB Institute of Validation Technology Quality Metrics Conference February 22 24, 2016 Coronado Island, San Diego, CA Personal Claim This
Q10 PHARMACEUTICAL QUALITY SYSTEM
Q10 PHARMACEUTICAL QUALITY SYSTEM This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights
Topics. Safety First Initiative. Drug Safety Communications DRUG SAFETY INITIATIVES AT THE FOOD AND DRUG ADMINISTRATION
DRUG SAFETY INITIATIVES AT THE FOOD AND DRUG ADMINISTRATION Presentation to the FDA/Industry Conference sponsored by the School of Pharmacy at Temple University May 6, 2008 Topics Safety First initiative
Evolution of the CMC Review - ANDAs
Evolution of the CMC Review - ANDAs Susan Rosencrance, Ph.D. Director (Acting), Office of Lifecycle Drug Products Office of Pharmaceutical Quality FDA Center for Drug Evaluation and Research October 6,
ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Keith O. Webber, Ph.D. Sr. Director, Global Regulator Affairs Rx Perrigo Company, plc Q U A L I T Y A F F
Appropriate Control Strategies Eliminate the Need for Redundant Testing of Pharmaceutical Products
Date: April 23, 2012 Appropriate Control Strategies Eliminate the Need for Redundant Testing of Pharmaceutical Products Key Messages Importation quality control testing for pharmaceutical, biological/biotechnology
Taking a Leap Toward Global Supply Chain Efficiency - Part II
Taking a Leap Toward Global Supply Chain Efficiency - Part II 2 Supply Chain Brochure - Part II INTRODUCTION Pharmaceutical manufacturers face a number of challenges in the production and delivery of medicinal
FDA Update on Compounding
FDA Update on Compounding Julie Dohm, JD, PhD Senior Science Advisor for Compounding, Center for Drug Evaluation and Research; Agency Lead on Compounding, FDA Compounding A Snapshot Compounded drugs: Are
Quality Metrics: A Regulatory Perspective
Quality Metrics: A Regulatory Perspective By Tara Gooen Bizjak, MBSci CDER Office of Policy for Pharmaceutical Quality Presented By Dr. Ademola Daramola US FDA Office of International Programs Indian Pharmaceutical
CANADA (HEALTH CANADA)
1 GMP GAZETTE TM May 2016 HPFBI CANADA (HEALTH CANADA) No updates NNHPD NHPs Final Monograph for Antiseptic Skin Cleanser Who`s Affected? Companies seeking NPN or DIN for topical antiseptic hand cleansers
DATA INTEGRITY ASSURANCE AS KEY FACTOR FOR SURVIVING CORPORATE AUDITS AND REGULATORY INSECTIONS
GLOBAL PROVIDER, LOCAL SOLUTIONS IN YOUR LANGUAGE DATA INTEGRITY ASSURANCE AS KEY FACTOR FOR SURVIVING CORPORATE AUDITS AND REGULATORY INSECTIONS Francesco Amorosi PhD Octorber 2017 DATA INTEGRITY & CSV:
DSCSA Implementation: Product Tracing Requirements for Dispensers Compliance Policy (Revised)
DSCSA Implementation: Product Tracing Requirements for Dispensers Compliance Policy (Revised) Guidance for Industry This guidance is for immediate implementation. This guidance is for immediate implementation.
Collaboration: GS1 and Joint Initiative Council (JIC) in Healthcare
Collaboration: GS1 and Joint Initiative Council (JIC) in Healthcare International Organisation for Standardization European Committee for Standardization Health Level 7 international International Health
INFORMATION ON JAPANESE REGULATORY AFFAIRS
2017 INFORMATION ON JAPANESE REGULATORY AFFAIRS Regulatory Information Task Force Japan Pharmaceutical Manufacturers Association Pharmaceutical Administration and Regulations in Japan Japan Pharmaceutical
Globalization and the FDA The Alliance for a Stronger FDA Quarterly Member Meeting February 8, 2012
Globalization and the FDA The Alliance for a Stronger FDA Quarterly Member Meeting February 8, 2012 Deborah M. Autor, Esq. Deputy Commissioner for Global Regulatory Operations and Policy U.S. Food and
Overview of the Drug Supply Chain Security Act. GPhA Fall Technical Conference Bethesda, MD October 28, 2014
Overview of the Drug Supply Chain Security Act GPhA Fall Technical Conference Bethesda, MD October 28, 2014 Disclaimer This presentation contains a summary of the opinion and perspective from GPhA member
Introductions and Perspectives on International Harmonization
Introductions and Perspectives on International Harmonization FDA/PQRI Conference on Evolving Product Quality September 17 th 2014 Mark Rosolowsky, PhD Vice President Global Regulatory Sciences CMC Bristol-Myers
Responding to an FDA 483
Responding to an FDA 483 Jim Melancon VP, Associate General Counsel BioScrip, Inc. Marc Stranz, PharmD Healthcare Consultant Disclosure The speakers declare no conflicts of interest or financial interest
Process Validation for Active Pharmaceutical Ingredients (API)
National University of Singapore Academy of GxP Excellence (NUSAGE) and PharmEng Technology Presents Process Validation for Active Pharmaceutical Ingredients (API) Part of the Pharmaceutical and Biotechnology/Training
ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective
ISPE Japan Affiliate 2016 Annual Meeting, April 14-15, 2016, Tower hall Funabori, Tokyo, Japan ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective Yasuhiro Kishioka, Ph.D. Principal
Textvergleich. Verglichene Dokumente MEDIA3917.pdf. ICH_Q10_Step4.pdf
Textvergleich Verglichene Dokumente MEDIA3917.pdf ICH_Q10_Step4.pdf Übersicht 2270 Wort/Wörter hinzugefügt 1338 Wort/Wörter gelöscht 3558 Wort/Wörter übereinstimmend 157 Block/Blöcke übereinstimmend Blättern
Key Definitions 6/16/2015
Technology Transfer from a CDMO Perspective Joe Cobb, CPIP Director, Pharmaceutical Development Metrics Contract Services, a division of Mayne Pharma US 18-June-2015 Key Definitions CDMO Contract Development/Manufacturing
GxP Auditing, Remediation, and Quality System Resourcing
GxP Auditing, Remediation, and Quality System Resourcing TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 6 GLP Auditing 7 Pharmacovigilance Auditing 7 Vendor/Supplier Auditing
FDA FSMA Timeline. July 29, 2009 House version passed. Nov. 30, 2010 Senate version passed. Dec. 19, 2010 Senate revised version passed
Food Safety Modernization Act (FSMA) FDA FSMA Timeline July 29, 2009 House version passed Votes 283-142 Nov. 30, 2010 Senate version passed Votes 73-25 Dec. 19, 2010 Senate revised version passed Unanimous
Impacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales. Innovacion en Packaging Primario
Impacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales Innovacion en Packaging Primario 1 Contents Company Highlight What s Changing in Pharma Pharma Trends Harmonisation New Requirements
GLOBALIZATION: CHALLENGES AND SOLUTIONS
GLOBALIZATION: CHALLENGES AND SOLUTIONS Kaiser J. Aziz, Ph.D. Senior Clinical & Regulatory Affairs Consultant The FDA Group, LLC THIS PRESENTATION WILL ADDRESS THE FOLLOWING TOPICS: Overview of Globalization
Developing a Robust Quality System to Assure Data Integrity
Developing a Robust Quality System to Assure Data Integrity Maryann Gribbin Chief Compliance Officer, Faith & Royale Consultants Co-Chair PDA Data Integrity Task Force Data Integrity Facts or information
Regulatory Starting Materials An FDA Perspective
Regulatory Starting Materials An FDA Perspective Kasturi Srinivasachar Branch Chief (Acting), New Drug API Division Office of New Drug Products, OPQ/CDER/ FDA 1 CDER Reorganization Office of Pharmaceutical
Starting Material Selection for Type II Drug Master Files
Starting Material Selection for Type II Drug Master Files Ronald S. Michalak Quality Assessment Lead (Acting), Division of Lifecycle API Office of New Drug Products, OPQ/CDER/ FDA CDER Reorganization Office
PMDA Perspective: Regulatory Updates on Process Validation Standard
CMC Strategy Forum Japan 2014 Tokyo, Japan, December 8-9, 2014 PMDA Perspective: Regulatory Updates on Validation Standard Kazunobu Oyama, PhD Office of Cellular and Tissue-based Products PMDA, Japan Disclaimer:
Supplier Assurance Program. CBE Pty Ltd
Supplier Assurance Program CBE Pty Ltd This training program is copyright to CBE Pty Ltd and may not be modified, reproduced, sold, loaned, hired or traded in any form without its express written permission.
Future of Pharmaceutical Quality and the Path to Get There
Future of Pharmaceutical Quality and the Path to Get There Lawrence Yu, Ph.D. Deputy Director, Office of Pharmaceutical Quality FDA Center for Drug Evaluation and Research 3rd PQRI/FDA Conference on Advancing
GxP Auditing, Remediation, and Staff Augmentation
GxP Auditing, Remediation, and Staff Augmentation TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 5 GLP Auditing 6 Pharmacovigilance Auditing 6 Vendor/Supplier Auditing 7
Products: A Global Perspective
CMC Changes to Biotechnology Products: A Global Perspective from Industry Toshiko Mori-Bajwa Director, Regulatory Affairs, CMC Amgen, Inc. All Changes are Not Considered Equal Innovator Process Change
FDA Process Validation
Page 1 of 5 Published on Controlled Environments Magazine (http://www.cemag.us) Home > FDA Process Validation FDA Process Validation Wai Wong Working with the New 2011 Guidelines. In January 2011, the
Evolving Regulatory Guidance on Submission of Standardized Data. James R. Johnson, PhD RTP CDISC User Network
Evolving Regulatory Guidance on Submission of Standardized Data James R. Johnson, PhD RTP CDISC User Network 2014-06-11 Originally Presented at PhUSE Conference 2013 Brussels, Belgium (Paper Number: RG03)
Labeling Best Practice in a Challenging Manufacturing Landscape A survival guide for pharmaceutical companies
Labeling Best Practice in a Challenging Manufacturing Landscape A survival guide for pharmaceutical companies White Paper www.nicelabel.com/pharma 1 1 Executive summary The number of challenges for the
Food and Drug Administration (FDA) 101
Food and Drug Administration (FDA) 101 What is the Food and Drug Administration (FDA)? The FDA is an agency within the U.S. Department of Health and Human Services that is responsible for protecting the
Regulatory system strengthening
SIXTY-SEVENTH WORLD HEALTH ASSEMBLY A67/32 Provisional agenda item 15.6 14 March 2014 Regulatory system strengthening Report by the Secretariat 1. The Executive Board at its 134th session noted an earlier
Understanding GxP Regulations for Healthcare
Understanding GxP Regulations for Healthcare GxP Guidelines What is GxP? GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their
Porton Biopharma Limited 1/17/17
Porton Biopharma Limited 1/17/17 10903 New Hampshire Avenue Silver Spring, MD 20993 Via UPS Warning Letter 320 17 19 Return Receipt Requested January 19, 2017 Dr. Roger J. Hinton Managing Director Porton
ISPE Annual Meeting 29 October 1 November 2017 San Diego, CA. Combination Product Updates, Initiatives, and Case Studies. Steven B. Hertz, P.E.
Combination Product Updates, Initiatives, and Case Studies Steven B. Hertz, P.E. Consumer Safety Officer, FDA/CDER/OPQ Agenda 1: CP Overview 2: CDER Updates : CP Application Info : Case Studies 5: Summary
Where Quality Meets Flexibility
Where Quality Meets Flexibility is an industry leading 503B Outsourcing Facility providing sterile and non-sterile compounding services to hospitals, surgery centers, clinics, researchers & patients nationwide.
GCP Basics - refresher
p. 01 GCP Basics - refresher Agenda: p. 02 Brief History of GCP GCP Regulations Principles of ICH E6 Sponsor Responsibilities Computer Systems Common Compliance Issues Brief History of GCP 3 Brief History
Industry Perspective on Manufacturing in Early Development
Industry Perspective on Manufacturing in Early Development IQ Workshop, Feb 4-5, 2014, Washington, D.C. Eric Schmitt AbbVie IQ Drug Product Manufacturing Working Group August 2012 issue of Pharmaceutical
Global Regulatory News
Online Exclusive from PHARMACEUTICAL ENGINEERING THE OFFICIAL TECHNICAL MAGAZINE OF ISPE JANUARY/FEBRUARY 2015, VOL 35, NO 1 Copyright ISPE 2015 www.pharmaceuticalengineering.org regulatory compliance
Introduction to GMPs and Validation WILLIAM GARVEY AND ASSOCIATES
Introduction to GMPs and Validation WILLIAM GARVEY AND ASSOCIATES William Garvey and Associates LLC 2016 Introduction About your instructor William (Bill) Garvey Important regulations and events Good Manufacturing
Managing Risk and Uncertainty Through the Drug Life cycle. Recent FDA Initiatives. Theresa Mullin, PhD
Managing Risk and Uncertainty Through the Drug Life cycle Recent FDA Initiatives Theresa Mullin, PhD Director Office of Strategic Programs US FDA Center for Drug Evaluation and Research October 14, 2014
API Testing Requirements to Support the EI Risk Assessment. Elisabeth Corbett Associate Director, GRS-CMC, Bristol-Myers Squibb November 9, 2016
API Testing Requirements to Support the EI Risk Assessment Elisabeth Corbett Associate Director, GRS-CMC, Bristol-Myers Squibb November 9, 2016 Agenda Background Review of ICH Q3D Risk Assessment Principles
Data Reliability - Internet
Data Reliability - Internet Wikipedia https://en.wikipedia.org/wiki/reliability_of_wikipedia Others http://www.dailymail.co.uk/health/article- 2639910/Do-NOT-try-diagnose-Wikipedia-90-medicalentries-inaccurate-say-expertsDo.html
Establishment of Clinical Trial Infrastructure
Taiwan s Strategy in the Establishment of Clinical Trial Infrastructure Chei-Hsiang Chen, Ph. D. Director, Biotechnology and Pharmaceutical Industries Program Office, Ministry of Economic Affairs, Taiwan
An Industry Perspective: The Complexity of Postapproval CMC Changes and Proposed Regulatory Strategies. SPEAKER: Suzanne Murray Biogen
An Industry Perspective: The Complexity of Postapproval CMC Changes and Proposed Regulatory Strategies SPEAKER: Suzanne Murray Biogen Contents 1. BioPhorum Operations Group (BPOG) and the Post-approvals
Essential Update on Contract Manufacturing and Quality Standards CPhI, Paris.
Essential Update on Contract Manufacturing and Quality Standards CPhI, Paris. Guy Villax 7 th of October 2014 Agenda Short Introduction to Hovione Driving Forces Shaping the Market CMOs Innovators and
CTA/NDA Regulatory Landscape in China. Jack Xie, PhD, DABT SOT 2016
CTA/NDA Regulatory Landscape in China Jack Xie, PhD, DABT SOT 2016 Disclaimer The content of the following presentation represents solely author s view and may not reflect any position of Roche or China
Introduction to U.S. Drug Shortages
Introduction to U.S. Drug Shortages CAPT Valerie Jensen, R.Ph. Associate Director Drug Shortage Program Center for Drug Evaluation & Research U.S. Food & Drug Administration 1 Overview U.S. Drug Shortage
GxP Auditing, Remediation, and Staff Augmentation
GxP Auditing, Remediation, and Staff Augmentation TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 6 GLP Auditing 7 Pharmacovigilance Auditing 7 Vendor/Supplier Auditing 8
Drug Substance Review in the Office of Pharmaceutical Quality
Drug Substance Review in the Office of Pharmaceutical Quality GPhA 2015 CMC Workshop Bethesda, MD June 9, 2015 M. Scott Furness, Ph.D. Deputy Director, Office of New Drug Products Office of Pharmaceutical
Continuous Manufacturing Achieving the Vision of Modernizing Pharmaceutical Manufacturing
Continuous Manufacturing Achieving the Vision of Modernizing Pharmaceutical Manufacturing FDA-AIChE Workshop on Adopting Continuous Manufacturing February 29 March 1, 2016 Rapti Madurawe, Ph.D. Acting
The Impact of Quality Culture on Quality Risk Management. FDA Perspective on Quality Culture; how it Impacts Risk Management
The Impact of Quality Culture on Quality Risk Management FDA Perspective on Quality Culture; how it Impacts Risk Management Teresa Gorecki Practice Lead Compliance Architects Agenda The WHAT Definitions
Cold Chains Are Hot! EXECUTIVE SUMMARY. Mastering The Challenges Of Temperature-Sensitive Distribution In Supply Chains
Cold Chains Are Hot! EXECUTIVE SUMMARY Mastering The Challenges Of Temperature-Sensitive Distribution In Supply Chains RFID in Life Science Series: Part 1 Authored By: Carla Reed Copyright ChainLink Research
Prescription Product Supplier Requirements
Prescription Product Supplier Requirements Prescription Product Suppliers: Prescription product suppliers are those suppliers that manufacture, package, or distribute a prescription pharmaceutical (drug)
Title II Licensure of Wholesale Distributors and 3PL s:
Title II Licensure of Wholesale Distributors and 3PL s: Where does FDA stand, where do states stand, what about VAWD, and what can you do about it? Elizabeth A. Gallenagh, Senior Vice President, Government
Overview. A brief from
A brief from Dec 2017 Getty Images What Are Compounded Drugs, and How Can They Be Kept Safe? Drug Quality and Security Act plays key role in important but potentially high-risk aspect of health care Overview
Guidance for Industry
Guidance for Industry Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage DRAFT GUIDANCE This guidance document is being distributed for comment purposes
This article specifically covers incorporation of physical and chemical indicators (PCIDs) into or onto the drug product.
Introduction The pharmaceutical industry is criminalized with circulation of counterfeit drugs risking healthcare and the life of users. This has become quite menacing in recent times with the lure of
Quality Related to Tracked Safety Issues (TSI) An Ophthalmic Case Study
Quality Related to Tracked Safety Issues (TSI) An Ophthalmic Case Study Avin Lalmansingh, Ph.D. CDER/OPQ/OLDP/ Division of Post marketing Activities II 2017 AAM CMC Workshop May 24 th, 2017 DISCLAIMER
USP General Chapter <1079> Pharmacopeia Forum. for Drug Products
USP General Chapter Pharmacopeia Forum Good Storage and Transportation Practices for Drug Products IATA Vancouver/March 8-12, 2010 Mary Foster, PharmD USP Expert Committee Member, 2005-2010 2010
Q&A on ICH Q7 Good Manufacturing Practice Questions and Answers Document
Q&A on ICH Q7 Good Manufacturing Practice Questions and Answers Document March 2017 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 1 ICH Q7 - Questions
Theodore Sullivan Partner Quarles & Brady LLP (Washington, DC)
Rachael Pontikes Partner Duane Morris LLP (Chicago, IL) Theodore Sullivan Partner Quarles & Brady LLP (Washington, DC) Moderator: Brian Malkin Counsel Arent Fox LLP (Washington, DC) 1 Legality of Animal
Pre-Approval Inspections for Drug Products
Pre-Approval Inspections for Drug Products FDA Small Business Regulatory Education for Industry Conference June 20, 2013 H.L. Jamillah Selby Consumer Safety Officer FDA, Dallas District Office Presentation
Health Canada Enforcement of Consumer Products
September 27, 2016 Vietnam Buyers Training Health Canada Enforcement of Consumer Products Jerry Wu Regional Manager, Consumer Product Safety Health Canada OVERVIEW Monitoring the Marketplace Inspections
FDA s Final Rule on Medical Device Data Systems Signals Active Regulation of Data Communication Technologies
ADVISORY February 2011 FDA s Final Rule on Medical Device Data Systems Signals Active Regulation of Data Communication Technologies Contacts On February 15, 2011, the U.S. Food and Drug Administration
Trinity College Dublin QP Forum 2017 Tuesday 25 th April
Trinity College Dublin QP Forum 2017 Tuesday 25 th April HPRA QUESTIONS & ANSWERS 1. What is the approach being taken for audit of contamination control strategies as per chapters 3 & 5? What is the current
Supplier Oversight PQRI. September Steven Lynn, MS, CMQ/OE Vice President Global Quality Compliance Mylan
Supplier Oversight September 2014 PQRI Steven Lynn, MS, CMQ/OE Vice President Global Quality Compliance Mylan Agenda Mylan Background Setting the Stage with a Scenario Current State Thinking Supplier Qualification
Progress Report on Recommendations of 14 th International Conference of Drug Regulatory Authorities (ICDRA) from WHO South-East Asia Region (SEAR)
Progress Report on Recommendations of 14 th International Conference of Drug Regulatory Authorities (ICDRA) from WHO South-East Asia Region (SEAR) 14 th ICDRA, Singapore, December 2010 Dr K A Holloway,
Guidelines for Process Validation of Pharmaceutical Dosage Forms
Guidelines for Process Validation of Pharmaceutical Dosage Forms Version 2.1 Date issued 21/02/2010 Date of implementation 21/05/2010 31 August 2010 Page 1 of 20 Guidelines for Process Validation of Pharmaceutical
White Paper: Food Safety Enforcement and Inspection Actions and Terminology
USDA-FNS White Paper: Food Safety Enforcement and Inspection Actions and Terminology MULTI-AGENCY TASK FORCE FOR USDA FOODS USDA, Food and Nutrition Service This document provides an overview of basic
Implementation of 2005 Pharmaceutical Affairs Law and ICH Q8-Q10 in Japan
JCCT workshop on Q8/Q9/Q10 Beijing Implementation of 2005 Pharmaceutical Affairs Law and ICH Q8-Q10 in Japan Yukio HIYAMA Chief, 3 rd Section, Division of Drugs National Institute of Health Sciences, Ministry
CERTIFICATE IN BIOPHARMACEUTICALS
Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034-2713 Phone: 267.468.8560 Fax: 267.468.8565 CERTIFICATE IN BIOPHARMACEUTICALS and GENERIC DRUGS Temple offers
Harmonizing FDA Regulation and the Practice of Pharmacy: Challenges and Opportunities. Plus an update on PET Drug User Fees
Harmonizing FDA Regulation and the Practice of Pharmacy: Challenges and Opportunities Plus an update on PET Drug User Fees Michael Nazerias - Vice President, RA/QA PETNET Solutions, Inc. (a Siemens Company)
Perspectives on FDA s Secure Supply Chain Pilot Program
Perspectives on FDA s Secure Supply Chain Pilot Program PDA Annual Meeting, Las Vegas, March 16-18, 2015 Facts around US imports Did you know that the US imports: 40% of finished dosage drugs 80% of Active
Food and Drug Administration Reauthorization Act of 2017
L A W O F F I C E S HYMAN, PHELPS & MCNAMARA, P.C. 7 0 0 T H I R T E E N T H S T R E E T, N.W. S U I T E 1 2 0 0 W A S H I N G T O N, D. C. 2 0 0 0 5-5 9 2 9 ( 2 0 2 ) 7 3 7-5 6 0 0 F A C S I M I L E (
Combination Products Part 4 Compliance and Implementation at multi-site Network
Combination Products Part 4 Compliance and Implementation at multi-site Network Vijay Damodaran Eli Lilly & Company September 27, 2017 Contents Key cgmp requirements for combination products How to perform
The Future of Generic Pharmaceuticals
The Future of Generic Pharmaceuticals David R. Gaugh, R.Ph. Senior Vice President, Sciences and Regulatory Affairs Generic Pharmaceutical Association A Look Ahead Aging Demographics 1 YEARS OF AGE A Look
Safety Assurance and Traceability Of Materials through the Supply Chain
Safety Assurance and Traceability Of Materials through the Supply Chain Roger Clemens, DrPH Chief Scientific Officer Horn Adjunct Professor, Pharmacology & Pharmaceutical Sciences USC School of Pharmacy
Hosting Inspections from foreign countries: PMDA (Japan) ANVISA (Brazil)
Hosting Inspections from foreign countries: PMDA (Japan) ANVISA (Brazil) Kathrin Abelein Vice President Quality, R-Pharm, JSC First Russian GMP Conference 20. 22. September 2016 Agenda General information