Improvement in QC Environmental Monitoring Processes with Paperless Data Capture System
|
|
|
- Leon Davis
- 8 years ago
- Views:
Transcription
1 Improvement in QC Environmental Monitoring Processes with Paperless Data Capture System Presented by Susan Harrison Senior Manager, Microbiology Jeremy Tanner QC Information System Specialist
2 Co-sponsors MODA Technology Partners, Inc More Science. Less Paper. 2
3 Today s Presenters Susan Harrison Senior Manager, Microbiology Bob Toal VP Marketing Jeremy Tanner QC Information System Specialist MODA Technology Partners, Inc More Science. Less Paper. 3
4 60-Minute Agenda MODA Overview 45-Minute Presentation by Lonza 15-minute Interactive Q&A Wrap-up up, Next Webinar A copy of this presentation and the movie of the live session will be available for download from the MODA website shortly after the presentation MODA Technology Partners, Inc More Science. Less Paper. 4
5 Background: MODA Provide mobile data acquisition solutions that automate regulated manufacturing processes Pharmaceuticals to consumer products Office locations Wayne, PA Headquarters (suburban Philadelphia) London, England World-wide sales in North America, Europe, and Asia Strategic partners MODA Technology Partners, Inc More Science. Less Paper. 5
6 MODA Value Proposition 1. More science. Less paper. p Quickly move from paper-intensive QC Monitoring & Analysis 2. Increase operational efficiency, i improve quality, reduce costs MODA-EM offers mobile computing technology and advanced visualization tools MODA Technology Partners, Inc More Science. Less Paper. 6
7 Representative Customers MODA Technology Partners, Inc More Science. Less Paper. 7
8 The Paper-based QC Process Example: Manual Utility Sampling and Lab Processing NO Plan Print sampling schedule & labels per EM SOP Assign sampling activities to QC Analysts Reconcile planned samples with collected samples All samples accounted for? YES Close out sampling schedule per EM SOP NO Collect Put on sterile outer garments and enter processing area Identify area to collect samples from facility map Collect sample and affix label Record date, time and initials on paper schedule and media All samples collected YES Deliver sampling paperwork to QC Supervisor Deliver samples to Microbiology or Biochemistry for processing Process Record sample receipt Prepare samples for testing. Report media lot, equipment, dilution info Record incubation start date and time Incubate samples Record incubation stop date and time Analyze samples and record results Results in range? NO Notification of Alert or Action YES Review & Analyze Aggregate data Trend results Trends OK? NO Investigate excursion Report results YES MODA Technology Partners, Inc More Science. Less Paper. 8
9 The Paperless QC Process Example: Manual Utility Sampling and Lab Processing. 11 steps removed NO Plan Print sampling schedule & labels per EM SOP Assign sampling activities to QC Analysts Reconcile planned samples with collected samples All samples accounted for? YES Close out sampling schedule per EM SOP NO Collect Put on sterile outer garments and enter processing area Identify area to collect samples from facility map Collect sample and affix label Record date, time and initials on paper schedule and media All samples collected YES Deliver sampling paperwork to QC Supervisor Deliver samples to Microbiology or Biochemistry for processing Process Record sample receipt Prepare samples for testing. Report media lot, equipment, dilution info Record incubation start date and time Incubate samples Record incubation stop date and time Analyze samples and record results Results in range? NO Notification of Alert or Action YES Review & Analyze Aggregate data Trend results Trends OK? NO Investigate excursion Report results YES MODA Technology Partners, Inc More Science. Less Paper. 9
10 Paperless Efficiency Example Paper 8 hours Paperless 4 Hours = Savings 4 Hours MODA Technology Partners, Inc More Science. Less Paper. 10
11 Automated Reports & Analytics MODA Technology Partners, Inc More Science. Less Paper. 11
12 Webinar Focus Areas Lonza s Lean Six Sigma initiative Why MODA-EM for paperless QC Micro Lonza process improvements: reports, trending data, metrics Lonza ROI: Financial, Compliance, User Adoption Real-time Q&A with Lonza subject experts MODA Technology Partners, Inc More Science. Less Paper. 12
13 History Evaluated LIMSystem(s) Commercial off the shelf systems Tablet PC system Didn t proceed Corporate commitment MODA Technology Partners Presentation at PDA Conference Summer 06 Offered solution specifically for Environmental Monitoring (EM) Start-up company, flexible Investment MODA Technology Partners, Inc More Science. Less Paper. 13
14 Lean Six Sigma (LSS) Initiative Company wide initiative Eliminate Waste Reduce Lead/Labor Time LSS Microbiology Standardized EM program (SOPs) Revised SOPs and Forms Mistake-proofing (Forms) Maintenance of cleaning logs Reduce Lead and/or Labor Time Implement MODA-EM module Production staff performs all routine monitoring Eliminated unnecessary sites Revised requirements for Bacterial ID (based on criticality) Workshop held Three beta sites identified Timelines established Validated and implemented MODA Technology Partners, Inc More Science. Less Paper. 14
15 Lonza EM Program In support of 13 existing clean room suites; Walkersville, MD 1 clean room facility; Salisbury, MD Unique requirements (cell therapy to crab bleeding) Additional clean rooms to be built Program Total Particulates, Viable Air, Settling, Contact, Personnel Daily monitoring of Class 100 (ISO 5) & Class 10,000 (ISO 7) Production staff (>100) Perform most routine monitoring QC Micro staff (13) Plate enumeration, data review, trending, ID s Perform validations (aseptic process, cleaning, gowning) MODA Technology Partners, Inc More Science. Less Paper. 15
16 Micro EM Volume SOP Description Total (2006) Total (2007) Plate Enumerations BioProducts Cell Therapy 31,845 37,777 42,597 61, Total Particle Counts BioProducts Cell Therapy 8,650 4,291 11,258 7, Gowning Validations Various Aseptic Process Validations (APVs) BioProducts Cell Therapy Various Cleaning Validation Sessions (CVs) Total Testing 82, , MODA Technology Partners, Inc More Science. Less Paper. 16
17 Recurring Issues Paper based system (error prone) Duplication of effort Completing paperwork Data entry Timely data review (volume) Current database Limited selection of reports Time spent generating trending reports Not validated or CFR21 Part 11 compliant Requires data verification MODA Technology Partners, Inc More Science. Less Paper. 17
18 Paper-Based Data MODA Technology Partners, Inc More Science. Less Paper. 18
19 or Paperless Data MODA (Mobile Data Acquisition) Paperless Environmental Monitoring system Records same information as our current paper system Capable of generating trend reports User-friendly interface Selected three beta sites Sterility Core II LAL Core I CTS MODA Technology Partners, Inc More Science. Less Paper. 19
20 Current System vs. MODA Current System Particle-generating paper autoclaved into clean room Data capture onto paper Redundant Entry of data information in access/excel Numerous Corrections for Omissions and Errors MODA Clean room compatible *No paper* Real-Time electronic data capture Trending is manual, time- consuming and limited in scope One-Step Data Capture of information Reduces corrections through mandatory fields/dropdowns System generates a variety of automatic trend reports MODA Technology Partners, Inc More Science. Less Paper. 20
21 Implementation Timeline Sep 06 Vendor demo Dec 06 Discussed configuration Jan 07 Project kickoff Apr Aug 07 IT Transition delays Server requirements Computer hardware/software transition Jul 07 Oct 07 Nov 07 Dec 07 IT Support Software installed in test environment Installation Qualification (IQ) completed Operation Qualification (OQ) completed Performance Qualifications (PQ s) completed MODA Technology Partners, Inc More Science. Less Paper. 21
22 MODA Improves EM Processes Eliminates several steps from the paper-based p EM Process Reduces Task and Process Time Task Time Hands-on time to complete each task Process Time Turn Around Time Data readily available Improves overall compliance MODA Technology Partners, Inc More Science. Less Paper. 22
23 Current Paper-Based Process Flow Record Print Record Record Record Enter Forms Media Label Create Equip. Media Clean Expiration Plates Current Paper-Based Labels Process Room Calibration Expiration Dates Flow File Forms Record Data on Forms Dates Start Incubation Production Tasks Record Data on Forms Record Data on forms Complete Accession Log Collect Samples Submit Samples to QC Record Data on forms Exit Clean Room Stop Incubation Record Enumerate Data on Plates Forms QC Tasks Record Results on forms Verify Completed Verify Completed p Form (Analyst) (Analyst) Yes Incomplete No Follow up Verify Complete Form Excursion Complete ID Forms Enter into ID Database Excursion Log Spreadsheet Complete Notification Form, Corrective Action Form Notification Yes No Archive Forms File Completed Forms Data Entry Approve Forms Yes Complete Review Forms (Supervisor) No Trending Data Review Completed Forms Follow Up Manual Site/Type Charting Compile by Cleanroom/ Class Compile Excursions = Paper Based Task = Review/Trending Tasks Data Accuracy Trending Analysis/ Generate MODA Technology Partners, Inc More Science. Less Verification Paper. 23 Report = Process Tasks
24 Process Flow without Paper Tasks Enter Clean Room Start Incubation Label Plates Production Tasks Select Samples Collect Samples Submit Samples to QC Exit Clean Room Stop Incubation Select Samples Enumerate Plates Electronic Results Entry QC Tasks Excursion Complete ID Forms Enter into ID Database Complete Notification Form, Corrective Action Form Notification Yes No Data Entry Yes Complete Electronic Review and Approve No Trending Data Follow Up Manual Site/Type Charting Manual Site/Type Charting Compile by Compile by Cleanroom/ Class Class Compile Excursions Compile Excursions = Review/Trending Tasks Data Accuracy Verification Trending Analysis/ Generate Report = Process Tasks MODA Technology Partners, Inc More Science. Less Paper. 24
25 Process Flow with MODA MODA Technology Partners, Inc More Science. Less Paper. 25
26 User Feedback Perception Sampling, Incubation and Results Entry Prep Work Sampling Incubation Corrections Enumeration Report generation Monthly Trending Quarterly Trending Plate Counts Audit Report Review and Approval Review and Approve Corrections MODA Technology Partners, Inc More Science. Less Paper. 26
27 User Feedback Metrics Sampling and Incubation (Production) Prep Work Perform EM Incubation Corrections Results Entry (QC Micro) Prep Enumeration Data Entry Corrections Review and Approval Corrections Trending Monthly Quarterly Organism MODA Technology Partners, Inc More Science. Less Paper. 27
28 Estimated Time Savings Task Sampling and Incubation Time Saved Per person per day Number of Users per day Total Time Savings per day for Three cores 3 minutes 3 9 minutes Results Entry 36 minutes minutes Review and Approve 8 minutes 3 24 minutes Monthly Trending 13 minutes 5 65 minutes Quarterly Trending 17 minutes 1 17 minutes Excursion/Organism 22 minutes 1 22 minutes Trending TOTALS 4 hours Total Savings: 1 hour 20 minutes per core per day MODA Technology Partners, Inc More Science. Less Paper. 28
29 Model of Financial Benefits 1.3 hours/day x 3 beta sites = 3.9 hours/day 1.3 hours/day x 11 clean room suites = 14.3 hours/day 18.2 hours/day 8 hours day/analyst = FTEs Miscellaneous savings (binders, paper, ink, particle-counter tape, autoclave costs, archiving and storage of data) Favorable ROI MODA Technology Partners, Inc More Science. Less Paper. 29
30 cgmp Compliance Current System Significant number of documentation errors Long Turn around time for processing data Paper presents particulate and microbial contamination risk MODA Eliminates documentation errors Short-turn around time for processing data Clean room compatible equipment reduces contamination risk MODA Technology Partners, Inc More Science. Less Paper. 30
31 21 CFR Part 11 Compliance Current Database Access database for data storage is not validated No control of changes in access database No electronic signature for changes All users have all privileges. Data stored in binders that are stored on and off site. MODA Validated system Audit trail tracks all changes/records Electronic signature for all major steps to ensure traceability Varying levels of access to system dependent upon job function Data stored on servers that are backed up on a routine basis MODA Technology Partners, Inc More Science. Less Paper. 31
32 FDA Aseptic Processing Guide Regulatory Expectations* The quality control unit should provide routine oversight of near-term (e.g., daily, weekly, monthly, quarterly) and long-term trends in environmental and personnel monitoring data Trend reports should include data generated by location, shift, room, operator, or other parameters The quality control unit should be responsible for producing specialized data reports (e.g., a search on a particular isolate over a year period) with the goal of investigating results beyond established levels and identifying any appropriate follow-up actions. Significant changes in microbial flora should be considered in the review of the ongoing environmental monitoring data * Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good ManufacturingPractice MODA Technology Partners, Inc More Science. Less Paper. 32
33 Trending/Report Generation Compliance Current System 5 Analysts 8-10 hours per month after data entry Limited Scope of Trending Reports No Formal way of tracking flora Limited Time frames All trending performed by QC for QA and Manufacturing MODA Quick and efficient trending in real time Wide array of trend report formats Flora can be trended by person, site, room, facility Time frame can be specified Ease of trending allows others (QA, Manufacturing) to perform their own trending MODA Technology Partners, Inc More Science. Less Paper. 33
34 Benefits of MODA Clean room compatible equipment Instant data entry eliminating paper transpositions Eliminates duplication of efforts in data entry and trending Equipment Interface (MetOne Particle counter) 21 CFR Part 11 compliant Generation of timely trending reports Storage of paper documentation eliminated Severability: Continues sampling process without wireless internet connection Added bonus: DMS access through PC tablets i.e. Documentum, NovaManage MODA Technology Partners, Inc More Science. Less Paper. 34
35 Recommendation Based on potential cost savings, compliance, and end-user satisfaction, we recommended site-wide id implementation ti of MODA MODA Technology Partners, Inc More Science. Less Paper. 35
36 Path Forward Phased site-wide implementation Cell Therapy Media (Core, TBS, Hood, Sterilization & PMPD) LAL (Core II, Formulation & Salisbury) QC (Sterility Core I, Sterility Hood, Micro & backup/training) Other sites (QA Inspection, Utilities) Site Licensure Transition to new version Including VIP module Possible implementation ti at other company sites MODA Technology Partners, Inc More Science. Less Paper. 36
37 Summary Employed LSS tools to identify areas for improvement Used EM Program requirements to justify the need for a software solution Selected MODA-EM for beta site evaluation Demonstrated benefits Financial Compliance End-user satisfaction Corporate support for site-wide implementation MODA Technology Partners, Inc More Science. Less Paper. 37
38 Acknowledgments QC MODA Project Team Jeremy Tanner, Susan Harrison, Sue Stoops, Valerie Williams, Jennifer Lesko, Melissa McLearen, Joe Matta & Jason Smith Others QA: Vijaya Rangavajhula, Ward Broadrup, Heath Coats IT: Maria Hess, Makiese Lukama, Nicole Norwood, Greg Jilek Production: Kara Anlauf, Mike Shutty, Monyque Bruchey MODA Technology Partners Brad Turner, Michael Marshall, Steve Kirsch, Nicole Quinlan & Mike Desiderio MODA Technology Partners, Inc More Science. Less Paper. 38
39 Today s Cleanroom Source: Environmental Monitoring A Comprehensive Handbook, Volume 1 cleanroom touch pads or computer terminals that allow for automated data entry IN THE ROOM. palm-pilot-type of data collection devices that can directly download to the computer system and allow for direct data transfer without risk of contamination. real time data for many of the chemistry and microbiology tests that must be performed MODA Technology Partners, Inc More Science. Less Paper. 39
40 Today s QC Micro Lab Source: Environmental Monitoring A Comprehensive Handbook, Volume 2 analysis and trending of environmental data is essential to aid in the interpretation of process stability and assess overall control performance. EM Reports must be accurate, traceable, timely, and well-documented MODA Technology Partners, Inc More Science. Less Paper. 40
41 Bob Toal MODA (484) x133 Questions & Answers To submit a question, use the Q&A feature of WebEx (bottom right of your screen). If we do not answer a question online, we will be sure to follow up with an MODA Technology Partners, Inc More Science. Less Paper. 41
42 Wrap-up Additional Customer-Focused Events in 2009 Topics being considered: d Bridging the gap between LIMS and EM needs Advancements in automated Endotoxin testing Use of Pre-Barcoded d Media in QC Micro Advancements in automated Air Testing Personal consultation: Bob Toal, btoal@modatp.com, (484) x133 Learn more: A copy of this presentation and the movie of the live session will be available for download from the MODA website shortly after the presentation MODA Technology Partners, Inc More Science. Less Paper. 42
Workflow System for Paperless Air Monitoring Powered by MODA. Presented by
Introducing Hach s MET ONE Compliance Workflow System for Paperless Air Monitoring Powered by MODA Presented by Scott Hjelmervik Bob Toal Systems Director Vice President Hach Company MODA Technology Partners
MODA Solution Automated QC Microbiology Processes for Regulated Manufacturing
Pharma&Biotech MODA Solution Automated QC Microbiology Processes for Regulated Manufacturing Informatics for Rapid Testing Pharma&Biotech MODA TM Solution Informatics for Rapid Testing «Eliminate unnecessary
White Paper. The Gap Between LIMS Capabilities and Environmental Monitoring Needs. Abstract. The Environmental Monitoring Workflow
The Gap Between LIMS Capabilities and Environmental Monitoring Needs Abstract White Paper While laboratory tests are an important part of Environmental Monitoring (EM) operations, the EM workflow is complex
Design, Operation and Management of GTP/GMP Cell Engineering Facilities
Design, Operation and Management of GTP/GMP Cell Engineering Facilities Scott R. Burger, MD Advanced Cell & Gene Therapy BFDA 2007 International Symposium on Regulation of Human Cell and Tissue- Based
Building the Business Case for Automated Rapid Testing: Translating the benefits of rapid automated microbial testing into dollars saved
Building the Business Case for Automated Rapid Testing: Translating the benefits of rapid automated microbial testing into dollars saved A whitepaper by: Opportunities in Micro Quality Control According
Pharmagraph. GMP/GLP Monitoring System
Pharmagraph GMP/GLP Monitoring System Pharmagraph GMP/GLP Monitoring System Demonstrates GMP/GLP compliance for cleanrooms and laboratories Monitors, Alarms, Logs and Reports Airborne particle counts,
Pharmaceutical Industry Whitepaper
Pharmaceutical Industry Whitepaper Cleanroom Data Management Challenges Labor and time intensive particle counting documentation can be streamlined Cleanroom Data Management Challenges Introduction Pharmaceutical
Library Guide: Pharmaceutical GMPs
Library Guide: Pharmaceutical GMPs Table of Contents Overview...3 Courses Listed by Functional Area... 4 Course Descriptions: A Step-by-Step Approach to Process Validation (PHDV79)... 7 A Tour of the FDA
WinKQCL 5 Endotoxin Detection and Analysis Software We Analyze Endotoxin Data Every Day
Pharma&Biotech WinKQCL 5 Endotoxin Detection and Analysis Software We Analyze Endotoxin Data Every Day For Endotoxin Detection Pharma&Biotech WinKQCL 5 Software for Endotoxin Detection and Analysis WinKQCL
Facility Cleaning & Monitoring. Cleaning
Facility Cleaning & Monitoring Cleaning GTP Regulations: 21CFR Part 1271.190 Maintain facility in clean, sanitary & orderly manner Establish & maintain procedures for facility cleaning Assign responsibility
Raleigh, NC May 12 th & 13 th 2016. Meeting The New ISO Cleanroom Standards And Changing EU Guidance How Will You Comply?
Raleigh, NC May 12 th & 13 th 2016 Meeting The New ISO Cleanroom Standards And Changing EU Guidance How Will You Comply? The International Cleanroom Standards (ISO 14644-1 & 2) have been updated, these
TSI BIOTRAK REAL-TIME VIABLE PARTICLE COUNTER FACILITY MONITORING SYSTEMS
TSI BIOTRAK REAL-TIME VIABLE PARTICLE COUNTER FACILITY MONITORING SYSTEMS APPLICATION NOTE CC-105 (US) Introduction This application note will demonstrate how real-time viable particle count data will
Aligning Quality Management Processes to Compliance Goals
Aligning Quality Management Processes to Compliance Goals MetricStream.com Smart Consulting Group Joint Webinar February 23 rd 2012 Nigel J. Smart, Ph.D. Smart Consulting Group 20 E. Market Street West
Particle Monitoring Requirements in Pharmaceutical Cleanrooms
Particle Monitoring Requirements in Pharmaceutical Cleanrooms All drugs must be manufactured in accordance with the current Good Manufacturing Practice (cgmp) regulations. Pharmaceutical manufacturers
Cellular Therapy Liaison Meeting 10 September 2009 BECS. M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB
Cellular Therapy Liaison Meeting 10 September 2009 BECS M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB Definition from October 2007 draft guidance BECS Validation In the User s Facility
Risk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI
Risk-Based Environmental Monitoring Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Presenter Marsha Stabler Hardiman Over 20 years experience in the
FDA and the Compounding Pharmacy
FDA and the Compounding Pharmacy Scott Sutton, Ph.D. scott.sutton@microbiol.org 41 Overview of Presentation The Recent Events GCP and GMP Basics the 483 Review H.R. 3204 Outsourcing Facility Preparation
Computerised Systems. Seeing the Wood from the Trees
Computerised Systems Seeing the Wood from the Trees Scope WHAT IS A COMPUTERISED SYSTEM? WHY DO WE NEED VALIDATED SYSTEMS? WHAT NEEDS VALIDATING? HOW DO WE PERFORM CSV? WHO DOES WHAT? IT S VALIDATED -
Monitoring the autoclaving process in the pharmaceutical industry
Application Description AD/RandC/006-EN Monitoring the autoclaving process in the pharmaceutical industry - Provides independent verification and validation monitoring of the autoclaving process - Enables
Qualification of an Environmental Monitoring Program
[ Scott Sutton Qualification of an Environmental Monitoring Program Scott Sutton Microbiology Topics discusses various topics in microbiology of practical use in validation and compliance. We intend this
Regulatory Asset Management: Harmonizing Calibration, Maintenance & Validation Systems
Regulatory Asset Management: Harmonizing Calibration, Maintenance & Validation Systems 800.982.2388 1 Introduction Calibration, maintenance and validation activity, despite operating within the same department
ENVIRONMENTAL TESTING & MONITORING: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers A WHITE PAPER
A WHITE PAPER ENVIRONMENTAL TESTING & MONITORING: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers By Scott Mackin A WHITE PAPER ENVIRONMENTAL TESTING & MONITORING:
FDA 21 CFR Part 11 Electronic records and signatures solutions for the Life Sciences Industry
FDA 21 CFR Part 11 Electronic records and signatures solutions for the Life Sciences Industry The Rule 21 CFR Part 11 Handwritten signature means the scripted name or legal mark of an individual handwritten
Conducting Effective OOS or OOT Investigations for Unexpected Results from the BET Assay
Pharma&Biotech Conducting Effective OOS or OOT Investigations for Unexpected Results from the BET Assay Lonza Cologne GmbH, Cologne / 10 May 2013 Lonza Dealing with Unexpected Results in Routine Testing
Pharmaceutical, Biotech and Medical Device Manufacturers. Be Compliant and Audit Ready - Implement an LMS!
Pharmaceutical, Biotech and Medical Device Manufacturers Be Compliant and Audit Ready - Implement an LMS! Organizations in the life sciences industry such as pharmaceuticals, medical devices and biotech
Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy
Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy Global Pharma Sourcing Conference December 6-7, 2011 Philadelphia, USA Nigel J. Smart, Ph.D. Smart Consulting
Testing Automated Manufacturing Processes
Testing Automated Manufacturing Processes (PLC based architecture) 1 ❶ Introduction. ❷ Regulations. ❸ CSV Automated Manufacturing Systems. ❹ PLCs Validation Methodology / Approach. ❺ Testing. ❻ Controls
ISO/IEC 17025 QUALITY MANUAL
1800 NW 169 th Pl, Beaverton, OR 97006 Revision F Date: 9/18/06 PAGE 1 OF 18 TABLE OF CONTENTS Quality Manual Section Applicable ISO/IEC 17025:2005 clause(s) Page Quality Policy 4.2.2 3 Introduction 4
Monitoring manufacturing, production and storage environments in the pharmaceutical industry
Application Description AD/RandC/005-EN Monitoring manufacturing, production and storage environments in the pharmaceutical industry - Provides independent verification and validation of the manufacture,
ALACC Frequently Asked Questions (FAQs)
Updated October 17, 2012 ALACC Contents Web Introduction to FAQ... 2 FAQ #6... 3 ALACC Section: How to Meet ISO 17025 Requirements for Method Verification (Page 9)... 3 FAQ #13... 4 ALACC Section ALACC
Cord Blood Licensure. Session 2C: Advanced Cell Therapies April 11, 2013
Cord Blood Licensure Session 2C: Advanced Cell Therapies April 11, 2013 Objectives Describe rationale for cord blood licensure Cite licensure regulations Illustrate a case study of one program s pathway
Calibration & Preventative Maintenance. Sally Wolfgang Manager, Quality Operations Merck & Co., Inc.
Calibration & Preventative Maintenance Sally Wolfgang Manager, Quality Operations Merck & Co., Inc. Calibration: A comparison of two instruments or measuring devices one of which is a standard of known
INTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to
INTRODUCTION This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software
LIBRARY GUIDE. Online Courses. March 2012
LIBRARY GUIDE Online Courses March 2012 i Table of Contents OVERVIEW..................................................................................... 1 COURSE DESCRIPTIONS (LISTED ALPHABETICALLY)...............................................
Product Lifecycle Management in the Medical Device Industry. An Oracle White Paper Updated January 2008
Product Lifecycle Management in the Medical Device Industry An Oracle White Paper Updated January 2008 Product Lifecycle Management in the Medical Device Industry PLM technology ensures FDA compliance
Regulations Concerning
Regulations Concerning Airborne Particle Counting Two types of activities performed with an airborne particle counter: Classification focuses primarily on the environment Particle Counting Applications
Design, Construction, Commission, and Qualification of Critical Utility Systems: Part III
Design, Construction, Commission, and Qualification of Critical Utility Systems: Part III BY DAVID W. VINCENT AND HERBERT MATHESON HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SYSTEMS INTRODUCTION
MeriCal Quality Profile
January 5, 2015 Dear Valued Customer, Since the implementation of new federal regulations, MeriCal Inc. has received a large volume of questionnaires and surveys regarding our services and procedures.
Practical Series Seminars and Workshops INTENSIVE TRAINING IN ENVIRONMENTAL MONITORING, DISINFECTANT QUALIFICATION AND CLEANROOM CONTAMINATION CONTROL
QUALIFICATION AND CLEANROOM CONTAMINATION CONTROL Who should attend: Quality Assurance, Quality Control, Operations, Regulatory and Manufacturing Supervisors, Cleanroom Operators and Facilities Personnel
COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS
COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS Primer CONTENTS INTRODUCTION...3 QUALITY AND COMPLIANCE IN QUALITY CONTROL LABORATORIES...5 Compliance
4Sight Calibration Management Software
GE Measurement & Control Solutions 4Sight Calibration Management Software 4Sight calibration and maintenance management software provides visibility to the assets, data, and resources that affect maintenance,
9 Things you need to know about Continuous Monitoring Systems in FDA-Regulated Environments
9 Things you need to know about Continuous Monitoring Systems in FDA-Regulated Environments If you work in a life science company or any company that is regulated by the FDA, you know that you will have
Operations Management and the Integrated Manufacturing Facility
March 2010 Page 1 and the Integrated Manufacturing Facility This white paper provides a summary of the business value for investing in software systems to automate manufacturing operations within the scope
Introduction. Editions
Introduction TRAIN TRACK Employee Training Management Software gives you the tools you need to make sure employee training requirements are met. Assign required training for groups or individuals. Easily
MHRA GMP Data Integrity Definitions and Guidance for Industry January 2015
MHRA GMP Data Integrity Definitions and Guidance for Industry Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This
Environmental Monitoring
Environmental Monitoring Purpose of Environmental Monitoring Critical process within the pharmaceutical and biotechnology industries. Determines the microbial and particulate content of cleanroom air and
The Impact of 21 CFR Part 11 on Product Development
The Impact of 21 CFR Part 11 on Product Development Product development has become an increasingly critical factor in highly-regulated life sciences industries. Biotechnology, medical device, and pharmaceutical
How a LIMS Can Save Your Laboratory Money and Enhance Data Quality
How a LIMS Can Save Your Laboratory Money and Enhance Data Quality Steve Rayburn, Director of Training and Validation and Dr. Christine Paszko, Vice President of Sales and Marketing Accelerated Technology
MATRIX GEMINI LIMS AT WORK IN THE FOOD INDUSTRY
MATRIX GEMINI LIMS AT WORK IN THE FOOD INDUSTRY Real Time Traceability in Microbiology at Westward Laboratories Cornwall Quality is the Result "Using the configuration tools we have been able to update
ISO 9001:2008 STANDARD OPERATING PROCEDURES MANUAL
8200 Brownleigh Drive Raleigh, NC 27617-7423 Phone: (919) 510-9696 Fax: (919) 510-9668 ISO 9001:2008 STANDARD OPERATING PROCEDURES MANUAL ALLIANCE OF PROFESSIONALS & CONSULTANTS, INC. - 1 - Table of Contents
Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E.
Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E. President & CEO Agenda Introduction Who is Malisko Engineering? Title
1 The quality management system (QMS) is the corner stone of compliance to GMP. The QMS is made up of several documents, that when followed ensures the GMP compliance of the process, facility and company.
Why Use Software for Calibration Management? Calibration White Paper. Beamex. INCLUDES CUSTOMER CASE STORY: Heineken España A.S.
Beamex Calibration White Paper info@beamex.com Why Use Software for Calibration Management? INCLUDES CUSTOMER CASE STORY: Heineken España A.S. Calibration management software can benefit all sizes of process
Task Manager. Task Management
Task Management ibpms Business Process Applications (BPAs) are the innovative, new class of Service Oriented Business Applications (SOBAs) that help businesses automate and simplify the management of missioncritical,
ComplianceSP TM on SharePoint. Complete Document & Process Management for Life Sciences on SharePoint 2010 & 2013
TM ComplianceSP TM on SharePoint Complete Document & Process Management for Life Sciences on SharePoint 2010 & 2013 Overview With increasing pressure on costs and margins across Life Sciences, the industry
CHAPTER 13. Quality Control/Quality Assurance
CHAPTER 13 Quality Control/Quality Assurance Quality Control/Quality Assurance (QC/QA) can be defined as the set of planned and systematic activities focused on providing confidence that quality requirements
How to implement a Quality Management System
How to implement a Quality Management System This whitepaper will help you to implement a Quality Management System (QMS), based on Good Manufacturing Practice (GMP), ISO 9001 or ISO 13485 within your
Addressing Risk in Partner / Contractor Selection and Onboarding. Michael Davidson VP Quality Systems and Compliance March 2014
Addressing Risk in Partner / Contractor Selection and Onboarding Michael Davidson VP Quality Systems and Compliance March 2014 Industry Trends Pfizer Overview Pfizer s Approach Risk Based Robust Due Diligence
Diane Kadidlo MT(ASCP) SBB University of Minnesota Joanna Stanson, M.S. University of Pittsburgh
Production Records & Documentation Diane Kadidlo MT(ASCP) SBB University of Minnesota Joanna Stanson, M.S. University of Pittsburgh Production Records This Session: Production Records Basic Elements Regulatory
Considerations When Validating Your Analyst Software Per GAMP 5
WHITE PAPER Analyst Software Validation Service Considerations When Validating Your Analyst Software Per GAMP 5 Blair C. James, Stacy D. Nelson Introduction The purpose of this white paper is to assist
Aseptic preparations, including TPN, for a limited number of patients
Aseptic preparations, including TPN, for a limited number of patients Group F (TPN) 1 Objective Presentation of our business case: setting up an aseptic TPN production in the Hilton Pharmacy instead of
How CMOs are Turning Their Training Programs into Market Differentiators
How CMOs are Turning Their Training Programs into Market Differentiators How CMOs are Turning Their Training Programs into Market Differentiators A Contract Manufacturing Organization (CMO) has as much
Standardizing Best Industry Practices
MEDICAL DEVICES Current market conditions have created a highly competitive and challenging environment for the medical device industry. With stricter FDA regulatory oversight, increasing material costs
On-Site GMP Training GMP COMPLIANCE TECHNICAL
PharmaNet On-Site GMP Training GMP COMPLIANCE TECHNICAL 284 E Lake Mead Pkwy Suite C-278 Henderson, NV 89015 Phone: 702-558-0094 Fax: 702-558-0079 www.gmpseminars.com Key to Level of Program Level A: Program
GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 032-2 8 January 2010 RECOMMENDATION GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE
MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015
MHRA GMP Data Integrity Definitions and Guidance for Industry Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This
International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation
International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation Ludwig Huber, Ph.D. ludwig_huber@labcompliance.com Overview GMP requirements for Quality Control laboratories
Managing Compliance Risks with EAM / CMMS
Managing Compliance Risks with EAM / CMMS 01. Managing Compliance Risks with EAM / CMMS With recent changes at the FDA, it is increasingly important for Life Sciences companies to fully leverage EAM/CMMS
opennms reporting generation tool
opennms reporting generation tool Juan Pedro Escalona DevOps Southampton, UK - 2014 Juan Pedro Escalona DevOps / Systems Administrator with over 6 years experience administering different OS, network systems
NC SBI QUALITY ASSURANCE PROGRAM
NC SBI QUALITY ASSURANCE PROGRAM for the SBI Reviewed by: Deputy Assistant Director Bill Weis Date: Approved by: Assistant Director Jerry Richardson Date: Originating Unit: SBI Effective Date: July 25,
DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION
1 US FDA Form 483: A Case Study DISCUSSION TOOL PRESENTED TO THE AABB CT REGULATORY AFFAIRS SUBSECTION DEVELOPED BY FRAN RABE 2 Introduction This case study is intended to extract portions of information
Quality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702
Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 9.2 Status : APPROVED Effective: 9/25/2015 Page 2 of 23 Quality Manual Table of Contents
Clinical Data Management (Process and practical guide) Nguyen Thi My Huong, MD. PhD WHO/RHR/SIS
Clinical Data Management (Process and practical guide) Nguyen Thi My Huong, MD. PhD WHO/RHR/SIS Training Course in Sexual and Reproductive Health Research Geneva 2013 OUTLINE Overview of Clinical Data
Xiaoming Wang, MD. MS. Manager QC Microbiology ImClone Systems A wholly-owned subsidiary of Eli-Lilly and Company
Xiaoming Wang, MD. MS Manager QC Microbiology ImClone Systems A wholly-owned subsidiary of Eli-Lilly and Company USP Microbiological Best Laboratory Practices USP 32 page 616 Introduction: good laboratory
Roadmap for study startup
How-To Guide Roadmap for study startup Deploying Adobe technology to automate clinical study startup procedures Section 1: Introduction and overview 2 1.1 Introduction 2 1.2 Overview of the clinical study
Designing a CDS Landscape that Ensures You Address the Latest Challenges of the Regulatory Bodies with Ease and Confidence
Designing a CDS Landscape that Ensures You Address the Latest Challenges of the Regulatory Bodies with Ease and Confidence Heather Longden Senior Marketing Manager, Informatics Regulatory Compliance 2015
Compliance Control Procedure Execution Management System Reduces Compliance Risks by 10X
Compliance Control Procedure Execution Management System Reduces Compliance Risks by 10X By John Helfrich, VelQuest Corporation INTRODUCTION The top drug GMP violations in 2009 involved failings in manufacturers'
Laboratory Information Management System
Laboratory Information Management System Lab Inventory Statistical Process Control LIMS Calibration Stability Dispensing Reagents Management Instrument Interfacing ERP Interface Complaint Tracking Process
Computerized System Audits In A GCP Pharmaceutical Laboratory Environment
IVTGXP_july06.qxd 6/28/06 1:09 PM Page 36 Computerized System Audits In A GCP Pharmaceutical Laboratory Environment By Maintaining data integrity for both clinical laboratory processes and patient data
Computer System Validation - It s More Than Just Testing
Computer System Validation - It s More Than Just Testing Introduction Computer System Validation is the technical discipline that Life Science companies use to ensure that each Information Technology application
EXAMPLE <PROJECT NAME> DATE
EXAMPLE DATE TABLE OF CONTENTS 1. EXECUTIVE SUMMARY... 2 1.1. Issue... 2 1.2. Anticipated Outcomes... 2 1.3. Recommendation... 2 1.4. Justification... 3 2. BUSINESS CASE ANALYSIS TEAM...
TrackWise - Quality Management System
TrackWise - Quality Management System Focus area: Electronic Management of CAPA Systems in the Regulated Industry May 11, 2007 Yaniv Vardi VP, Operations Sparta Systems Europe, Ltd. Agenda Sparta Systems
ISCT Cell Therapy Liaison Meeting AABB Headquarters in Bethesda, MD. Regulatory Considerations for the Use of Software for Manufacturing HCT/P
ISCT Cell Therapy Liaison Meeting AABB Headquarters in Bethesda, MD September 10, 2009 David Doleski, Team Leader, Branch 2 Division of Manufacturing and Product Quality (DMPQ) Office of Compliance and
Project Update December 2, 2008 2008 Innovation Grant Program
Tri-University Vulnerability Scanning/Management Solution Project Update December 2, 2008 2008 Innovation Grant Program 1 Project Summary This grant application is part of a previous project report presented
Quality Assurance (QA) & Quality Control (QC)
Quality Assurance (QA) & Quality Control (QC) In the laboratory Georges Ruta Water Quality Scientist City West Water 1 City West Water Water Supply & Sewerage Authority Melbourne Pop. >800,000 Area 580
Electronic Raw Data and the Use of Electronic Laboratory Notebooks
7th WRIB- M-2 Workshop Electronic Raw Data and the Use of Electronic Laboratory Notebooks Ron Shoup Outline for Today Raw Data- defining it, creating it, and keeping it for posterity Hybrid Data- paper,
Leveraging Data to Create a Paradigm Shift from Reactive to Proactive Utility Management
Leveraging Data to Create a Paradigm Shift from Reactive to Proactive Utility Management Chuck Scholpp Director, Integrated Information Management Hach Company Brent Fewell VP, Environmental Compliance
EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART
EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,
ISO 9001:2008 QUALITY MANUAL. Revision B
ISO 9001:2008 QUALITY MANUAL Revision B Because we want you to achieve the highest levels of performance, we connect care Because with leading we want science you to achieve continuously the highest improve,
Quality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702
Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 9.1 Status : APPROVED Effective: 12/11/2014 Page 2 of 23 Quality Manual Table of Contents
A Complete Drug Stability Program. Stability Lab Information Manager SL IM
A Complete Drug Stability Program Stability Lab Information Manager SL IM SLIM is a Fully Validated, World-Class Stability LIMS. SLIM combines the ease of use of browser style user interface and industry
cgmp Challenges for Cord Blood Banks
cgmp Challenges for Cord Blood Banks Donna M. Regan, MT(ASCP)SBB St. Louis Cord Blood Bank @ SSM Cardinal Glennon Children s s Medical Center Cord Blood Bank processing facility challenges What does cgmp
Making Sense of Your Environmental Monitoring Data. Presented by Dawn McIver MicroWorks, Inc.
Making Sense of Your Environmental Monitoring Data Presented by Dawn McIver MicroWorks, Inc. Objectives Environmental Monitoring Basics Importance of Tracking and Trending EM Data Techniques for Tracking
Section 1 Project Management, Project Communication/Process Design, Mgmt, Documentation, Definition & Scope /CRO-Sponsor Partnership
Section 1 Project Management, Project Communication/Process Design, Mgmt, Documentation, Definition & Scope /CRO-Sponsor Partnership PROJECT MANAGEMENT - SCOPE DEFINITION AND MANAGEMENT Understands the
Effective Training for Cell Therapy Laboratories. Diane Kadidlo MT(ASCP) University of Minnesota Molecular and Cellular Therapeutics Facility
Effective Training for Cell Therapy Laboratories Diane Kadidlo MT(ASCP) University of Minnesota Molecular and Cellular Therapeutics Facility Training Personnel Biggest resource of an organization Reflect
OPERATIONAL STANDARD
1 of 11 1. Introduction The International Safe Transit Association (ISTA), a non-profit association whose objective is to prevent product damage and excess packaging usage within the distribution environment.
Continuous compliance through good governance
PCI DSS Compliance: A step into the payment ecosystem and Nets compliance program Continuous compliance through good governance Who are the PCI SSC? The Payment Card Industry Security Standard Council
CHAPTER 7 QUALITY ASSESSMENT
CHAPTER 7 QUALITY ASSESSMENT Chapter 7 QUALITY ASSESSMENT 7.1 OVERVIEW OF CBB-SPECIFIC QUALITY ASSURANCE/QUALITY CONTROL PROGRAM An extensive, site-specific Quality Assurance/Quality Control (QA/QC) program
Bika Open Source LIMS. Top level functional specification Inventory and Supply Chain Management
Bika Open Source LIMS. Top level functional specification Inventory and Supply Chain Management This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.