LaboratoryControls&Compliance PICK AND CHOOSE FROM OVER 40 INTERACTIVE WORKSHOPS AND SESSIONS 40 Hear from 32 Laboratory Experts including 2 Former FDA Officials and 17 Pharmaceutical/Biotechnology Manufacturers and Contract Labs… • AstraZeneca Liquid Production Sweden • AstraZeneca Pharmaceuticals • Aventis Pharma Deutschland GmbH • BD Medical Systems • Celgene Corporation • Chemir Pharma Services • Covance Laboratories Europe • DPT Laboratories • Eli Lilly and Company • G&W Laboratories, Inc. • GE Healthcare • GlaxoSmithKline • Hoffmann-La Roche • Intercell AG • Pfizer • Wyeth • Wyeth Vaccines Special Regulatory Focus for Laboratories: • Risk-Based and Science-Based Approaches • Risk Assessment and Risk Management • 21 CFR Part 11 and the Latest FDA Guidance • Current Regulatory Requirements • FDA Inspections and Trends CREATE-YOUR-OWN CONFERENCE: Pick and Choose from Over 40 Interactive Workshops, Expanded Sessions, and General Sessions Laboratory Controls & Compliance August 16-19, 2004 Philadelphia, PA Doubletree Hotel Media Partner: New Speaker Addition! FDA Regulations and Inspection Trends for the Laboratory Yvonne McKnight, Pharmaceutical Chemist, FDA
Transcript
LaboratoryControls&Compliance
PICK AND
CHOOSE FROM
OVER 40
INTERACTIVE
WORKSHOPS
AND SESSIONS
40
Hear from 32 Laboratory Experts including 2 Former FDA Officials and 17 Pharmaceutical/BiotechnologyManufacturers and Contract Labs…
• AstraZeneca Liquid Production Sweden• AstraZeneca Pharmaceuticals • Aventis Pharma Deutschland GmbH• BD Medical Systems• Celgene Corporation• Chemir Pharma Services• Covance Laboratories Europe• DPT Laboratories• Eli Lilly and Company• G&W Laboratories, Inc.• GE Healthcare• GlaxoSmithKline• Hoffmann-La Roche• Intercell AG • Pfizer• Wyeth• Wyeth Vaccines
Special Regulatory Focus for Laboratories:• Risk-Based and Science-Based Approaches • Risk Assessment and Risk Management • 21 CFR Part 11 and the Latest FDA Guidance• Current Regulatory Requirements • FDA Inspections and Trends
CREATE-YOUR-OWN CONFERENCE:Pick and Choose from Over 40 InteractiveWorkshops, Expanded Sessions, and General Sessions
Laboratory Controls & ComplianceAugust 16-19, 2004 Philadelphia, PA Doubletree Hotel
Media Partner:
New Speaker Addition!
FDA Regulations and Inspection Trends for the Laboratory
Yvonne McKnight, PharmaceuticalChemist, FDA
7:30 AM – Registration and Continental Breakfast
Workshop 8:30 am – 12:00 pmCalibration/Metrology Management for FDA-Regulated Industries
Richard Kucharyson, Automation Consulting and CalibrationServices Marketing Manager, Honeywell
The pharma industry has been drawing from various cali-bration, quality, and FDA GMP requirements to help imple-ment and control their instrument, equipment, andprocess calibration needs for validated control systems.Wewill explore strategies, techniques, and practices to helpdeliver a stable and solid calibration platform. You willlearn how to identify and create a cost effective and meas-urable modern calibration management system suitablefor the pharmaceutical industry.
I. Calibration Standards• Identify the industries that have calibration standards• Identify important cGMP calibration standards• Explain the golden rule of calibration
II. Calibration Flow • Identify the types of equipment to be calibrated • Describe Calibration Flow Charts with GMP requirements
III. Purpose & Benefits• Identify the purpose and benefits of calibrating equipment
IV. Calibration• Identify the MIL-STD-45662A, Z540-1-1994 and GAMP
definitions of calibration• Explain calibration certification
V. Introduction to GAMP Calibration Management• Explain the purpose of GAMP calibration management• Describe how the 4-to-1 Calibration Rule helps achieve
“high confidence”in product quality• Identify the elements of GAMP Calibration Management• Describe how to determine equipment critically• Discuss ISO/IEC 17025
VI. Calibration: Ensuring Good Quality andAccuracy
• Check equipment accuracy• Explain the purpose of 3-point calibration • Identify factors that affect the frequency of calibration • Describe the procedure to follow when an instrument is
out of tolerance • Describe a change control process
Workshop 8:30 am – 12:00 pmIdentification and Description of ElectronicLaboratory Records and Their Lifecycle
Akos Bartha, Ph.D.,Technical & Quality Adviser, AstraZenecaLiquid Production, Sweden
I. Electronic Records: Identifying What’s Neededwithin the Scope of Part 11• Identification of electronic records using a top-down
approach• Predicate rules and other record requirements• Electronic records required by Part 11• What to preserve and for how long• Practical template for documentation of record
requirements
II. Electronic Records Components• Understand what information constitutes a record• Learn about the importance and role of metadata• Components of the Good Electronic Record Management
(GERM) model • Ensure that records remain trustworthy• Discover a practical way of describing the components of
records
III. Record Lifecycle Concepts• The GERM model of record lifecycle• A simplified approach for defining the lifecycle of elec-
tronic records• System lifecycle versus electronic record lifecycle• Practical use of record lifecycle descriptions under FDA’s
narrow interpretation• Typical examples
IV. Record Identification Principles in Practice• Importance of structured working method and docu-
mentation• Steps to identifying and documenting records and their
lifecycle phases• Procedures and template uses through practical examples • Training and resources required• Benefits of documenting records and their lifecycles with
uniformity summarized
V. Interactive ExerciseAttendees will participate in an exercise for asimple laboratory system, using a work instruction andtemplates.They will identify the required records, docu-ment record requirements, describe the components ofthe electronic records, and identify their lifecycle phases.
BA
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
2
Pre-Registration Sunday, August 15, 6-7pmPre-Conference Half-Day Interactive Workshops
Monday, August 16, 2004
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
3
Workshop 8:30 am – 12:00 pmCurrent Good Manufacturing Practice (cGMP)Testing Requirements in a Pharmaceutical Lab
Karen S. Ginsbury, President, PCI Pharmaceutical Consulting
I. Overview of cGMP Requirements for Testing in aPharmaceutical Quality Control Laboratory
• European and U.S. FDA regulatory requirements• Training and qualification of technicians and supervisors• Facility requirements• Equipment qualification, calibration, maintenance• Reagent and culture controls• Test methods and specifications• Documentation and reporting requirements• Retained samples and stability programs• Methods validation: Statistical Process Control (SPC,) and
Out-of-Specification (OOS) results
II. Controls, Standards, and Out-of-Specification(OOS) Results
• Procedures for purchasing laboratory reagents• Water quality for testing• Positive and negative controls, duplicates, and replicates• Procedures for sampling, handling, and retesting samples
Workshop 8:30 am – 12:00 pmQualification for Laboratory Instrumentation andComputer Systems
Steve P. Calabro, Manager,Validation and LaboratoryControls, AAI International, KC & Gary Clapp, Ph.D.,VicePresident of Operations, AAI International, KC
I. Validation Protocols• Exploring examples of effective documents• Discussing the Master Validation Plan (MVP)• Discovering where to start, who performs what duties,
and at what intervals
II. Critical Content of Your Documents and theVendor’s or Third Party’s Validation Packages
• Holistic or modular approach to validation • Revalidation and Performance Validation (PV)• Instrument relocation
III. Legacy Instrument Validation and SystemTracking
• Validating a part or the whole• Opening and closing the equipment information loop• Tracking and documenting the lifecycle of an instrument
12:00 PM – Luncheon for Workshop A, B, C, DAttendees
12:00 PM – Main Conference Registration
1:15 PM – Latest FDA Guidelines/Regulations;Advanced Thinking for the Laboratory from the FDA
Sandy Weinberg, Ph.D., Senior Director, Fast Trak – Vaccines,GE Healthcare
This presentation provides an up-to-the-minute summary of new FDA concerns in the laboratory, including:• Guidelines, rules, regulations, and interpretation • Latest guidance on 21 CFR Part 11 • General requirements of a risk assessment• Other regulatory agencies
2:15 PM – FDA Enforcement Strategies for theLaboratory
John Markus, Sr. Regulatory Consultant, AACConsulting Group, Former Chief Chemist andInvestigator, FDA
This session provides an agency perspective on laboratory investigations. By reviewing FD-483s andWarning Letters, you will be able to understand andanticipate FDA’s enforcement strategy related tolaboratories. Attendees will discuss:• Quality in the laboratory • Documentation • Integrity and reliability of results• Processes used in the investigative process • Success in the regulatory laboratory
3:00 PM – Refreshment Break
3:30 PM – Documentation in an AnalyticalLaboratory: How Basic Handwritten andElectronic Documentation Can Save You Time and Effort with Investigations and Auditors
K. Elia, Director Global Compliance Operations,Wyeth
This session will address the documentation issues andconcerns in today’s modern analytical laboratory.Electronic and handwritten methods of laboratory docu-mentation practices will be presented to reduce time andultimately result in cost savings.We will discuss ways tominimize and even eliminate auditors’concerns or need to delve deeper in reviewing laboratory documentation.Attendees will:• Learn how to avoid the common causes for being unable
to reproduce an experiment or test performed• Understand how analysts’documentation is requisite
D
C
Pre-Conference Half-Day InteractiveWorkshops Monday, August 16, 2004
Main Conference • General SessionsMonday, August 16, 2004
• Learn what tools analysts need in order to documentclearly, concisely, coincidently, accurately, and easily
• Gain an understanding of pitfalls for both electronicand handwritten documentation
• Understand the documentation reviewer’s criticalrole in verifying that the documentation is clear, con-cise, constant, and accurate
4:15 PM – A Scientific Approach to AnalyticalInstrument Qualification (AIQ)
Surendra K. Bansal, Ph.D., Research Director,Hoffmann-La Roche
Analysts (users) use analytical instruments and gener-ate reliable data for their intended purpose. AIQ helpsto justify the continued use of such instruments. Noauthoritative guide exists that considers the risk ofinstrument non-performance and combines that riskwith users’ scientific knowledge and ability to use theinstrument to deliver reliable data. In the absence ofsuch a guide, the qualification of analytical instru-ments has become a subjective and often document-generating exercise.Taking its cue from the new FDAinitiative,“Pharmaceutical GMP’s for the 21st Century,”an efficient, science- and risk-based process for AIQwill be discussed.The resulting process emphasizesthe AIQ’s place in the overall process for obtainingquality, reliable data.• AIQ is a component of achieving quality in analytical
data; learn what the other components are • Learn the timing, applicability, and activities for each
phase (DQ, IQ, OQ, PQ) of AIQ• Define the roles and responsibilities of users, quality
assurance, and the manufacturer regarding AIQ • Categorize instruments for qualification purposes
5:00 PM – 6:00 PM Evening Discussion Group and Social Hour:
Preparing For and Passing FDA Inspections inthe Laboratory
Workshop 8:30 am – 12:00 pmEnsuring Access Databases and ExcelSpreadsheets are Part 11 Compliant
– Dr. Dirk Bissinger, Industrial Operations Drug Products,Quality Assurance Manager, Aventis Pharma
– Frank Pagliusi, Data Information Manager, Pfizer– David Harrison, Senior Consultant, ABB Eutech.– Ty Mew, President, Ofni Systems Inc.– Derek Wimmer, President,Wimmer Systems, Inc.
Practical advice on using Microsoft(r) Access andMicrosoft(r) Excel in the regulated environment, cov-ering the entire lifecycle of the implementation fromdesign through audit. Case studies provide real-lifeexamples of how leading companies have addressedthese issues.
I. Ensuring Excel Spreadsheets are Part 11Compliant
• Validating Excel spreadsheets and the challenges ofthe process
• Integrating Excel validation into your current CSVpractice• Balancing risk-based validation with efficiency• Introducing resource requirements, and key learning
points for Excel validation projects
II. Ensuring Access Databases are Part 11Compliant
• Databases for Part 11 compliance• Technical controls and functionality• Secure environment for Access software• Procedural controls required• Case studies and experiences across industry
III. Regulatory Audits of ComputerizedSystems
• Preparing for an inspection• Handling the inspection strategically• Discussing Aventis’experiences and audit outcomes
IV. Case Study of Aventis’ Excel SpreadsheetRemediation Project
• Aventis’approach to spreadsheet validation• Experiences with implementing a remediation
project• Business and regulatory benefits of implementation
E
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
4
Main ConferenceHalf-Day Interactive Workshops
Tuesday, August 17, 2004
Main Conference • General SessionsMonday, August 16, 2004
LabCompliance is a global online resource for validation andcompliance in laboratories. View and download more than100 pages and documents on www.labcompliance.com. Includes sections on method validation,computer validation, 21 CFR Part 11,warning letters, and free newsletterand discussion forum.
V. Case Study of Pfizer’s Implementation ofABB+Wimmer Systems DaCS™ for ExcelSpreadsheet Remediation
• Global spreadsheet remediation project management• Handling the diverse spreadsheets in the field• Business and regulatory benefits of implementation
Laboratory compliance is a major issue for all pharmaceu-tical firms, and the laboratory should have an on-goingprogram of self-assessment.This session will provide thebackground and tools for self-assessment.
I. Interactive Discussion: Establishing theLaboratory Assessment/Audit Program
• Regulations, including 21 CFR 211• Standards, including ISO 17025• Guidance, including ICH Q7A, GMP Preamble, Guide to
Inspection of Quality Control Laboratories• Internal procedures• Audits, scheduling
II. Performing a Laboratory Assessment • Auditor activities to plan for; questions to ask• Laboratory procedures that should be in place• Elements that should be contained within procedures• Records that are required by the procedures• Laboratory personnel who should be reviewed• Proper procedures and verifying that the laboratory is fol-
lowing them
III. Follow-Up of the Assessment• Developing a Corrective and Preventative Action (CAPA)
Plan• Supporting the assessment program: management
responsibility
Workshop 8:30 am – 12:00 pmConducting an Effective Laboratory FailureInvestigation: Writing an Investigation Report
Ann Gartska, Manager of Policies and Standards, CelgeneCorporation
A majority of FD-483 observations have been cited forpoor laboratory investigations.Writing an effective investi-gation is more than just putting pen to paper; it must be asuccinct, accurate description of an investigation. A well-written laboratory investigation takes into account root
cause analysis, CAPA, and trending. In this presentation,attendees will examine how to conduct an effective labo-ratory failure investigation, and it will provide soundguidelines on how to write an investigation report.
I. Evaluating Laboratory Data• Reviewing and discussing of the Barr Decision• Defining the difference between Out-of-Trend (OOT),
Out-of-Specification (OOS), and outliers• Scrutinizing the data; asking the right questions
II. Root Cause Analysis (RCA)• Developing critical thinking and investigation skills; basic
RCA mechanics• Identifying key contributing factors associated with test
methods, specifications, and laboratory equipment• Recognizing Root Causes (RCs) to respond to non-com-
pliance, failures, deviations, and complaints• Using innovative techniques for determining RC
III. CAPA – Solution Strategies • Highlighting the difference between corrective action
and preventive action• Determining the right CAPA, and how to best use this sys-
tem• Choosing and implementing the corrective action
IV. Trend Analysis• Identifying what to trend – quality markers• Identifying problems through effective use of trends
analysis
V. The Laboratory Investigation• Developing a checklist as a tool for failures• Exploring enhanced documentation practices to prevent
‘reinventing the wheel’ syndrome• Identifying lab investigations that should prompt manu-
facturing investigations
VI. Interactive Exercise Complaint Investigations
Attendees will review examples of com-plaint investigations and CAPA-related documentation.Attendees will critique examples of forms and documentsas related to writing styles and techniques.
Workshop 8:30 am – 12:00 pmTaking the Mystery Out of Pharmaceutical andMedical Device Stability Programs
Len Lawrence, QA Manager, BD Medical Systems
I. The Stability Program
H
G
F
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
5
Main Conference • Half-Day Interactive Workshops Tuesday, August 17, 2004
II. The Stability Chambers• Chamber Design: identifying the right chamber for the
intended purpose• Chamber Monitoring: defining daily and monthly moni-
toring requirements• Chamber Validation: validating a new and modified sta-
bility chamber• Chamber Control: maintaining a chamber and ensuring it
meets requirements• Chamber Calibration: discussing what needs to be includ-
ed in a chamber calibration
III. Stability Indicating Methods• Defining the components of a stability indicating method• Method Validations: performing stability-indicating
method validations• Method Qualifications: qualifying USP methods for both
active, inactive, and raw materials• Method Transfers: defining requirements for transferring
methods between laboratories• Method Control: enumerating the controls that should be
in place when updating and/or changing test method
IV. Stability Study Designs• Matrixes: developing a matrix and related considerations• Bracketing: bracketing, how and when to use it• Stability Parameters: testing - chemical, microbiological,
and physical tests
V. Stability Data Reporting• Study Reports: gathering data and formatting• Annual Product Reviews: identifying stability data and
data trending that needs to be included• Annual Reports: submitted to the FDA on each year:
including the correct elements and how they may differ from annual product reviews
VI. Interactive Activities• Stability Procedures: providing hands-on experience in
writing and understanding the contents of a stability pro-gram
• Stability Chamber Validation: determining the stabilitychamber validation protocol, content, and execution
12:00 Luncheon
1:15 PM – Current FDA Inspection Trends in theLaboratory and the System-Based Approach
David R. Dills, Director of FDA Regulatory Compliance &Validation Services, Focus Compliance & Validation Services
This session will provide a general overview of some of themost recent FDA inspections involving laboratoryoperations, including some of the well-known red flags.This session also introduces the audience to very recent483s, warning letters, and discusses the CPGM 7356.002(Compliance Program Guidance Manual) for DrugManufacturing Inspections.This session will address labo-ratory deviations and deficiencies covering allaspects of laboratory controls and compliance strategies.
2:00 PM - Planning For and Managing FDAInspections
Timothy P. Bechard, Principal Auditor,Wyeth Vaccines
This session will review the different methods of enforce-ment used by the FDA. FDA’s authority and expectations ofindustry will be discussed. Proper behavior during theinspection, at the exit meeting, as well as interactions withthe FDA, and discussion patterns to avoid, will be present-ed. Roles and responsibilities of the Inspection ReadinessTeam will be discussed as part of the preparation effort forinspections.Tips on FDA inspection techniques and rea-sons for FDA 483’s will be covered.The Do’s and Don’ts ofinspection will be reviewed.The potential path of an audi-tor through observation examples will be presented.• Learn the objectives of an inspection and the expecta-tions of industry.• Understand how discussion patterns with inspectors caninfluence the outcome of the inspection.• Learn how an inspection readiness team can avoid prob-lems and be better prepared.• Gain knowledge of inspection techniques and limitationsof authority.
2:45 PM – Refreshment Break
3:15 PM – A Mechanistic Approach to AberrantData Investigations for Analytical LaboratoryResults
Phil Meeks, CEO, Chemir Pharma Services
Aberrant data investigations can lead to retesting in orderto properly resolve an issue. One must balance the needfor such activities without inadvertently spiraling into acampaign of "testing into compliance." This presentationwill provide guidance for utilization of a mechanisticapproach to laboratory investigations. A system will be dis-cussed that allows for scientific, laboratory management,
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
6
Main Conference • General SessionsTuesday, August 17, 2004
Main ConferenceHalf-Day Interactive Workshops
Tuesday, August 17, 2004
and quality assurance staff to make rational decisionsbased on scientifically sound data. A step-wise approachwill be detailed.• Distinguishing between assignable, suspected, and unas-signable cause• Deciding between a resampling versus retestingapproach• Determining when not to retest• Practical tips for designing retest plans• Tracking and trending of data
4:00 PM – Reducing OOS Investigation Backlogs:Strategies to Prevent OOS Results Due ToAnalytical Error
Paul Newton, Ph.D.,Technical Project Manager,GlaxoSmithKline
This presentation will address the cost of laboratory inves-tigations due to analytical error. Prevention of OOS resultsdue to avoidable analytical test method error will also bediscussed in detail, with practical recommendations fortheir elimination.Tips will be provided on how to over-come invalid OOS results once they have been generated.• Common causes of OOS results due to analytical error• Laboratory analysts and how they can contribute to erro-neous test results• Invalid OOS results and how you can avoid generatingthem as regards 21 CFR Part 11 regulation• Test methods and how they can introduce error
4:45 PM – Upgrading a Pharmaceutical Laboratoryfor Part 11 Compliance
Akos Bartha, Ph.D.,Technical & Quality Adviser, AstraZenecaLiquid Production, Sweden
AstraZeneca LPS has a large quality control laboratory withmany systems bought from different vendors.This results ina number of challenges for bringing computerized systemsinto compliance with regulations for Electronic Recordsand Electronic Signatures (ER/ES). In order to optimize costsfor investment, validation and system administration, acommon strategy for compliance and IT-technical remedia-tion is needed.This lecture will present strategies and expe-riences from our ER/ES project, including examples of pro-cedural and technical remediations for laboratory systems.The impact of FDA’s new guidance on interpretation andremediation work will also be discussed.
6:00 PM – OPTIONAL Dinner Workshop andEvening Social: How to Build a Risk Assessmentand Risk Management Program
Ty Mew, President, Ofni Systems Inc.(Must pre-register to attend this dinner)
7:30 AM – Continental Breakfast
Workshop 8:30 am – 12:00 pmAnalytical Test Method Validation and Verification
Paul Newton, Ph.D.,Technical Project Manager,GlaxoSmithKline
I. Understanding Method Validation Terms andCurrent FDA Requirements and Other RegulatoryAgencies
• Definitions for each method validation parameter • Expectations emerging from current InternationalConference on Harmonization (ICH)
II. Designing the Process to be Meaningful andValuable: Specific Experiments and AcceptanceCriteria
• Detailed, specific experimental approaches to methodvalidation
• Specific quantitative acceptance criteria for each valida-tion parameter
III. Managing the Method Validation Process toIncrease Future Value, and Acting on ExperimentalFindings
• Establish standardized and optimized processes• Effective method validation exercises and testing with
properly validated test methods
IV. Documenting the Method Validation Exerciseto Realize Maximum Value
• Performing appropriate method validation exercises isnecessary, but not sufficient• Examining the quality of the validation exercise
V. Interactive Exercise: Understand MethodVerification, and Learn to Achieve It
Learn what is meant by, and is currently expected, regardingmethod verification. Attendees will discuss how method ver-ification is appropriate, versus performing full method vali-dation. Method verification documentation options will bediscussed, as well as what to do with this documentationonce it is completed.The issue of which specific extra activi-ties can be of potential benefit, and which activities add nopractical value will also be covered.
I
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
7
Main Conference • General SessionsTuesday, August 17, 2004
Main Conference • Half-Day Interactive Workshops
Wednesday, August 18, 2004
Workshop 8:30 am – 12:00 pmImplementing FDA’s New Approach for 21 CFRPart 11 in Laboratories
Ludwig Huber, Ph.D., Compliance Program Manager, AgilentTechnologies
To obtain the maximum benefit form this workshop,download workshop and reference material from theInternet: www.labcompliance.com/ivtGoing from paper to electronic records can significantlyincrease a laboratory’s efficiency. FDA’s regulation on elec-tronic records/signatures enables laboratories to fullyimplement electronic records systems. FDA’s risk-basednew approach for part 11 allows you to implement theregulation at lower cost. Using practical examples, thisworkshop will enable attendees to understand laboratory-specific requirements, and implement them using themost cost-effective approach.
I. Introduction to Part 11 and Impact onLaboratories
• Overview of Part 11 requirements• FDA’s new Part 11 guidance: scope and applications• Update from the FDA/Industry meeting in June 2004• New Part 11 rule making
II. Implementing Critical Requirements• Auditing, when e-audit trail is a must• Printing data and deleting e-records• Archiving and retrieving of data/meta data: short versus
long-term strategies• Making MS Excel applications compliant with Part 11
III. Structured Approach to Define and DocumentScope and Controls
• Identify and document business practices• Identify a regulated activity• Justify and document risks• Document your decision for the FDA and your management
IV. Interactive Exercise: Laboratory Case Studies
Using prepared case studies from a laboratory, small teams will discuss which typical records should complywith Part 11, and what this means in practice.
Workshop 8:30 am – 12:00 pmUsing Statistics for Manufacturing and QualityControl
Steven S. Kuwahara, Ph.D., Principal Consultant, GXPBioTechnology, LLC
Participants should bring calculators if they wish to partici-pate in the interactive parts of this presentation.
I. How to Compare Measurements• How to use the t-test to compare averages• How to compare two numbers• How to compare uncertainty levels
II. How to Measure the Uncertainty in Attribute Data • How to determine the problem• How to approach and solve it
III. How to Detect Outliers• What is a real outlier• How to determine the presence of a real outlier • How to decide which of the many outlier tests to use• Interactive: Calculating outliers by various methods
IV. How to Determine the Number of Replicates to Test• How a simple situation illustrates what information is
needed• How to determine replicates and specification setting• How to handle attribute data• How to overcome the problem of small samples and
attribute data• Interactive: How to calculate the proper numbers of
replicates
V. How to Establish Statistical Process (Quality)Control
• What is the History and theory• What are the basics of setting up different variables• How to think about attribute versus continuous variables• How to calculate the parameters of an SPC chart• Interactive: Calculation of the parameters for an attribute
chart
Workshop 8:30 am – 12:00 pmGMP Requirements for Training Programs ofLaboratory Personnel
Jerry Lanese, President,The Lanese Group, Inc.
I. Training Program• Where is it described• Program content• Responsibility for managing the program, and maintain-
ing the records
II. Job Description• Human relations department responsibilities• Laboratory responsibilities
L
K
J
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
8
Main Conference • Half-Day Interactive WorkshopsWednesday, August 18, 2004
III. Training Plan• Format review• Content, timing, and responsibilities
IV. Proficiency Testing• Does proficiency testing apply to all positions, and to all
skills• How is proficiency testing performed• What is the source of samples, and how to evaluate
results
V. Maintaining Demonstrated Proficiency• How is proficiency maintained• Does maintaining proficiency apply to all tasks or skills
12:00 PM – Luncheon
90-Minute Post-Conference Expanded SessionsWednesday, August 18, 2004
Session 1:30 pm – 3:00 pmDevelopment and Validation of Stability-Indicating Analytical Methods
Phil Meeks, CEO, Chemir Pharma Services
I. Developmental Requirements• Discussion of laboratory prerequisites • Method requirements • Role of forced degradation • Analytical instrument review
II. Validation Requirements• Setting of acceptance criteria• Defining FDA and ICH expectations• Discussing of validation characteristics• Coupling of validation tests
III. Development and Validation Process• Blending of science and regulations • Discussing quality perspectives • Using protocols • Defining re-validation requirements
IV. Interactive ActivityThis session will review the challenges in transfer of devel-oped and validated methods from R&D to QC. Attendeeswill break into groups, and a case study will be discussedwithin each group.
Session 1:30 pm – 3:00 pmValidation Case Study - Meeting the Requirementsof the OECD (Organization for EconomicCooperation and Development) GLP ConsensusDocument of Computerized Systems
Marian Mutch, QA Staff Associate, System Validation,Covance Laboratories, Europe
I. Understanding the OECD GLP ConsensusDocument: The Application of GLP Principles toComputerized Systems
• Background of the document • Responsibilities identified within the document• Key elements, including the importance of documentation
II. Validating a Computerized System• Validation methodology• Project planning• Validation team, their roles and responsibilities• Communication channels
III. Completing a Case Study• Strategy for the validation of a Chromatography Data
System, (CDS)• Validation Team Activities• Deliverables for each project phase• Continuity of the validated state
IV. Interactive ActivityAttendees will discuss their experiences of the validationof computerized systems, and share with each other somebest practices on meeting the challenges of ensuring thatsystems are maintained in a validated state.
Session 1:30 pm – 3:00 pmComputer System Audits in a PharmaceuticalLaboratory Environment
Hans Martens, Computer System Auditor, Eli Lilly andCompany
I. Scope: Currently, computers and computer systems are every-where and part of your daily life in the laboratory.Examples include: laboratory equipment, Laboratory man-agement Information System (LIMS), the network, servers,databases, individual workstations, or remote access toyour data.The laboratory staff, IT, and the Quality Controldepartment must work together to understand how ITimpacts their business and how to set appropriate con-trols. A practical and non-technical overview of what youneed to think about.
3
2
1
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
9
90-Minute Post-Conference Expanded SessionsWednesday, August 18, 2004
II. Performing a Laboratory Assessment:• Determine the scope of the assessment• Determine the standards for the IT-environment• Interpret your findings• Create an action plan
III. Interactive Session:Discussion of a number of examples from the laboratory.Attendees will have the opportunity to work through somelaboratory computer system examples, using the principlesand standards described in this presentation to familiarizethemselves with the computer system environment.
Session 1:30 pm – 3:00 pmRegulatory Considerations for the Testing ofSamples Obtained from Subjects in Clinical Trials
Steven S. Kuwahara, Ph.D., Principal Consultant, GXPBioTechnology, LLC
I. Regulatory Framework• Why GLP and GMP do not apply• What does apply
II. Rules and Regulations Concerning ClinicalSamples
• Federal Regulations• State Regulations• Examples from the State of California
III. Quality Issues• Quality Requirements• Personnel Requirements
IV. Interactive Session• A clinical trial scenario will be presented involving inter-
nal and external testing.
3:00 PM – Refreshment Break
Session 3:30 pm – 5:00 pmGMP Jeopardy…Can You Afford the Ri$k?
Anne M. Garstka, Manager of Policies and Standards, CelgeneCorporation
I. Identify and Understand Risk in the LaboratorySetting
• Gain insight from inspectional observations and FDAexpectations
• Learn how to adapt HACCP concepts as a tool to identify risk • Develop and implement training to recognize potential risks
II. Develop and Implement Risk ManagementTools for Use in the Laboratory
• Gain insight into applying risk assessment as a risk man-agement tool
• Learn how to develop a ’culture of compliance’as a pre-ventive risk tool
• Learn how to use Root Cause Analysis as a risk manage-ment tool
III. The Co$t of Risk• Understand the compliance burden involved with poor
risk judgment• Differentiate between tangible and intangible costs of risk• Learn about some outstanding fines imposed
IV. Interactive Session: GMP Jeopardy: ApplyingRisk Assessment Knowledge to the World ofPharmaceutical Decision Making
Using their GXP knowledge and indus-try experience,selected attendees will go through a “gameshow quiz”to determine their risk level. This interactive ses-sion will allow ‘contestants’to apply their own riskstyle/approach against inspectional observations,FDA expec-tations,and industry practices.
Session 3:30 pm – 5:00 pmProper Qualification and Use of ReferenceStandards in the Pharmaceutical AnalyticalLaboratory
Mike Cutrera, Director – ARMD, G&W Laboratories, Inc.
This presentation will cover the following key aspects ofthe proper characterization, qualification, and use of refer-ence standards in the laboratory:
I. Establishing and Qualifying a ReferenceStandard
• Analytical and physical tests• Microbiological tests• Certification
II. Using Best Scientific and Compliance Practices• Calibration• Traceability to recognized reference
III. Storing, Handling, and Using of ReferenceStandards in the Laboratory
• Standard inventory and usage
IV. Establishing the Shelf Life and Re-Qualificationof Reference Standards
6
5
4
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
10
90-Minute Post-Conference Expanded SessionsWednesday, August 18, 2004
V. Defining Requirements for the ProperDocumentation of Reference Standards
• Characterization of the standard• Comparison of house standard to compedial standard
Session 3:30 pm – 5:00 pmRisk-Based Approach toValidation/Documentation of Computer Systems
Robert W. Stotz, Ph.D.,Vice President,ValidationTechnologies, Inc.
On August 21, 2002 the US Food and Drug Administration(FDA) announced “a significant new initiative to enhancethe regulation of pharmaceutical manufacturing andproduct quality and to bring a 21st Century focus to thisFDA responsibility.”The goals of the initiative are to focusregulatory attention on those aspects of manufacturingthat pose the greatest risk, to ensure that FDA’s work doesnot impede innovation, and to enhance the consistency ofFDA’s regulatory approach. Although the agency has beenproposing and implementing risk-based programs for anumber of years, the intent of the new initiative is to devel-op a more systematic and rigorous risk-based approach.
I. FDA/Industry Activity and InfrastructureDevelopment
• Review FDA activity and industry practice• Develop a procedure/guideline for a risk-based approach
II. Criteria for Classification of Computer Systems• Defining the criteria for classification into critical or non-
critical systems• Basing documentation requirements on potential of sys-
tem to adversely impact quality or release status of products
III. Function Risk-Assessment Methodology• Determining risk associated with each major system
function• Defining categories of risk• Assessing risk based on probability and consequences of
failure• Discussing example methodology
IV. Interactive Exercise• Attendees will be provided with example documentsfrom a number of projects involving assessment of risk for laboratory and process equipment, as well as for docu-ments for a database management system. Attendees willhave an opportunity to perform a risk assessment.
Session 3:30 pm – 5:00 pmSpecial Considerations for OOS LaboratoryInvestigations of Batch Uniformity
Paul Newton, Ph.D.,Technical Project Manager,GlaxoSmithKline
I. Strategies to Prevent Out-of-Specification(OOS) Uniformity
• Preventing OOS uniformity results by optimizing the lab-oratory analytical process
• Investigating for uniformity OOS results should bedesigned differently from the "normal" OOS result labo-ratory investigation
• Developing laboratory investigation protocols
II. The Potential Gains and Risks• Differences between uniformity and non-uniformity test
results• Batch uniformity testing• Examples of laboratory investigation procedures• Industry examples on uniformity samples
III. Interactive ExerciseAttendees will share ideas of how they currently performlaboratory investigations for uniformity testing
5:00 pm – 6:00 pm Evening Discussion Group andSocial Hour:Effectively Managing International Compliance inToday’s Laboratories
Ludwig Huber, PhD, Compliance Fellow, Agilent Technology
Laboratories are frequently faced with the situationwherein they must comply with multiple regulations andquality standards. Examples are GLP’s, GMPs, and GCP’sfrom multiple countries; ICH; and the ISO Standard 17025.Complying with all these can be quite time consumingwhen trying to develop and implement procedures indi-vidually for each situation.This presentation will discuss astrategy for addressing multiple requirements with a sin-gle quality system.
8
7
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
11
90-Minute Post-Conference Expanded SessionsWednesday, August 18, 2004
Doubletree Hotel Philadelphia 237 South Broad Street Philadelphia, Pennsylvania, 19107-5686 USATelephone: (215) 893-1600Fax: (215) 893-1664www.philadelphia.doubletree.com
Contact the hotel directly and mention IVT to receive the reduced room rate.
Hotel Information
7:30 AM – Continental Breakfast
Session 8:30 am – 10:00 amRegulatory Agency Perspective: Auditinga Quality Control Pharmaceutical Laboratory
Jay S. Allen, Sr. Consultant, Stelex – The Validation Group,former FDA Investigator
I. Achieving Laboratory Compliance• Equipped and staffed laboratory is essential for compli-
ance with cGMPR• Laboratory requirements of 21 CFR subpart 1 – Sections
211.160, 211.176
II. Conducting the Audit• Receipt and documentation of samples received• Step-by-step determination of a laboratory’s compliance• Requirements for maintaining compliance
III. Interactive Exercise: FDAObservations• Discuss common observations found during the FDA
inspections
Session 8:30 am – 10:00 amRegulatory Requirements for Change Control inthe Laboratory
Jerry Lanese, President,The Lanese Group
I. Regulatory Requirements for Change Control• 21 CFR 211• Proposed amendments• International Conference on Harmonization (ICH) Q7A
II. The Change Control System• Relation of laboratory to site change control system
III. Laboratory-Specific Changes• Changes to specifications, sampling plans, and test
methods• Change of site • Change of instruments or instrument components
Session 8:30 am – 10:00 amAnalytical Methods Transfer: The Right Way andthe Wrong Way
Linda Proctor, President, Blue Water Technical Services, LLC
I. What are the Regulatory Requirements andExpectations for Methods Transfer?
• Decision making• Basis for the decisions
II. When are Analytical Methods TransfersRequired?
• Development and research to production• Site to site• Site to contract
III. What are the Considerations for MethodsTransfer
• Equipment• Solvents, columns• Analyst• Reproducibility; how good is good enough
IV. What are the Pitfalls of Methods Transfer
V. Interactive –Designing a MethodsTransfer ProtocolThe participants will develop methods transfer protocols andestablish acceptable limits for variation.
Session 8:30 am – 10:00 amEstablishing Meaningful System SuitabilityCriteria for Chromatographic & Non-Chromatographic Systems
Bradford J. Mueller, Ph.D., Manager-Analytical Development,AstraZeneca Pharmaceuticals LP
System suitability tests are conducted on analytical sys-tems to establish their acceptability for use in GMP datageneration. ICH and national compendia require such test-ing.The selection of appropriate tests and acceptance cri-teria are dependent upon the required specificity, sensitivi-ty, accuracy, and precision of the analytical measurement.The suitability tests and corresponding acceptance criteriashould ensure that the analytical system is capable ofdelivering results which will meet the intended purpose ofthe analytical method. In this presentation, the develop-ment of appropriate system suitability criteria for variousanalytical systems will be discussed. Guidance on theselection of appropriate system suitability requirementswith respect to the product specifications is provided.
Interactive Exercise:Attendees will have an opportunity to “develop”meaning-ful system suitability tests for hypothetical analytical meth-ods based on drug product characteristics and qualitycontrol limits.
12
11
10
9
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
12
90-Minute Post-Conference Expanded SessionsThursday, August 19, 2004
Session 10:30 am – 12:00 pmValidation of HPLCs Used in RegulatoryApplications
Jeff Schlichting, Manager of Quality Systems, DPTLaboratories
I. Validation as Part of a Documentation System• Validating a process and not an event• Documenting the instrument lifecycle• Documenting validation activities
II. Creation of the Validation Protocol• Writing user specifications• Defining elements of Installation Qualification (IQ),
Operational Qualification (OQ), and PerformanceQualification (PQ) for High Performance LiquidChromatography (HPLC)
• Managing change control and revalidation• Discussing expectations and pitfalls of vendor validation
protocols
III. Classification Strategy for LaboratoryInstruments
• Defining scope of documentation• Supporting documentation• Documenting practices for instrument failure
IV. Interactive Exercise: Instrument SystemsAttendees will classify an instrument system, propose OQand PQ challenges, and develop on-going performance test-ing based on the provided user specifications.The group willthen perform an assessment of a number of instrument fail-ures and discuss documentation practices.
Session 10:30 am – 12:00 pmGuidelines for Handling Out-of-Trend QC results
Mohammad M. Kazemi, PhD, Quality Compliance Consultant
I. Understanding Different Types of OOT QCResults
• Defining and classifying of OOT results• Distinguishing between different types of OOT results
II. Investigating OOT Results• Investigating OOT results• Considering the different phases of investigation• Emphasizing the importance of a successful root cause
analysis of OOT results• Exploring corrective and preventive measures for contin-
uous improvement of procedures and processes
III. Retesting, Documenting, and Handling OOTResults According to FDA Guidance Document
• Flow chart covering how to handle various OOT results• Elements to consider for repeat test and retesting of OOT
results• Elements to consider when compiling final reportable
results• Proper documentation of OOT results investigation
IV. Interactive Exercise:• Discuss examples of various factors to con-
sider in laboratory and manufacturing phases of investi-gation
• Historical data for investigation
Session 10:30 am – 12:00 pmFrom Research to Routine - Implementing GoodLaboratory Practice (GLP) in a DevelopmentLaboratory
Thomas Kreuzer, Quality Operations, Intercell AG (Vienna)
• Setting priorities for the implementation of GLP require-ments
• Documenting requirements in the laboratory • Developing training programs• Establishing instrument qualification and maintenance
programs• Qualifying analytical methods prior to routine use• Establishing a practical approach for implementation
Session 10:30 am – 12:00 pmProper Documentation and SOPs to EnsureCompliance in the Laboratory
Linda Proctor, President, Blue Water Technical Services, LLC
I. Developing SOPs for Laboratory Equipment• Operating and procedural environment SOPs
II. Training and Validation Documentation• Developing appropriate training• Training records• Validating, calibrating, and change control
III. Investigational Documentation• OOS and resolutions
IV. Interactive ExerciseThis session will include a checklist to deter-mine the challenges of writing effective and accurate SOPs
16
15
14
13
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
13
90-Minute Post-Conference Expanded Sessions Thursday, August 19, 2004
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
14
Institute of Validation Technology w w w. i v t h o m e. co m 561-790-2025
SUNDAY, AUGUST 156:00 pm – 7:00 pmPre-Registration
MONDAY, AUGUST 16, 20048:30 AM – 12:00 PMPre-Conference Half-DayInteractive Workshops
7:30 AM – Registration andContinental Breakfast
8:30 am – 12:00 pm
WORKSHOP A
Calibration/MetrologyManagement
WORKSHOP B
Identification and Description of Electronic Lab Records
WORKSHOP C
cGMP Testing Requirements
WORKSHOP D
Qualification for LaboratoryInstrumentation & ComputerSystems
12:00 PM Luncheon forWorkshop A, B, C, D attendees
Main Conference GeneralSessions
12:00 PM
Main Conference Registration
1:15 PM
Latest FDA Guidelines/Regulations
2:15 PM
FDA Enforcement Strategies
3:00 PM
Refreshment Break
3:30 PM
Documentation in an AnalyticalLaboratory
4:15 PM
A Scientific Approach to AnalyticalInstrument Qualification
5:00 PM
Evening Discussion Group andSocial Hour: Preparing for andPassing FDA Inspections in theLaboratory
TUESDAY, AUGUST 17, 2004Main Conference Half-DayInteractive Workshops
7:30 AM – ContinentalBreakfast
8:30 am – 12:00 pm
WORKSHOP E
Access Databases and ExcelSpreadsheets - Part 11Compliance
WORKSHOP F
The Self Audit: Assessing LabCompliance
WORKSHOP G
Lab Failure Investigations:Writing an Investigation Report
WORKSHOP H
Pharmaceutical and MedicalDevice Stability Programs
12:00 Luncheon
Main Conference GeneralSessions
1:15 PMFDA Inspection Trends and the
System-Based Approach
2:00 PMPlanning for and Managing FDA
Inspections
2:45 PMRefreshment Break
3:15 PMAberrant Data Investigations
4:00 PMReducing OOS Investigation
Backlogs
4:45 PMUpgrading a Lab for Part 11
Compliance
5:30 PMClose of Day Two
6:00 PMOPTIONAL Dinner Workshop and
Evening Social: How to Build aRisk Assessment and RiskManagement Program(must pre-register to attend)
WEDNESDAY, AUGUST 18, 2004Main Conference Half-DayInteractive Workshops
7:30 AM – ContinentalBreakfast
8:30 am – 12:00 pm
WORKSHOP I
Analytical Test Method Validationand Verification
WORKSHOP J
Implementing FDA’s NewApproach for 21 CFR Part 11
WORKSHOP K
Using Statistics forManufacturing and QC
WORKSHOP L
GMP Requirements for TrainingPrograms
12:00 PM – Luncheon
90-Minute Post-ConferenceExpanded Sessions
1:30 pm – 3:00 pmSESSION 1
Development and Validation ofStability-Indicating AnalyticalMethods
SESSION 2
GLP Consensus Document ofComputerized Systems
SESSION 3
Computer System Audits
SESSION 4
Regulatory Considerations forthe Testing of Samples fromClinical Trials
3:00 PM – Refreshment Break
3:30 pm – 5:00 pmSESSION 5
GMP Jeopardy…Can You Affordthe Ri$k?
SESSION 6
Proper Qualification and Use ofReference Standards
WEDNESDAY, AUGUST 18, 200490-Minute Post-ConferenceExpanded Sessions continued
3:30 pm – 5:00 pm
SESSION 7
Risk-Based Approach toValidation of Computer Systems
SESSION 8
Considerations for OOS LabInvestigations of BatchUniformity
5:00 pm – 6:00 pmEvening Discussion Group and
Social Hour: Effectively ManagingInternational Compliance inToday's Laboratories
THURSDAY, AUGUST 19, 2004 90-Minute Post-ConferenceExpanded Sessions
7:30 AM – ContinentalBreakfast
8:30 am – 10:00 am
SESSION 9
Auditing a Quality ControlPharmaceutical Laboratory
SESSION 10
Change Control in the Laboratory
SESSION 11
Analytical Methods Transfer
SESSION 12
Establishing Meaningful SystemSuitability
10:30 am – 12:00 pm
SESSION 13
Validation of HPLCs
SESSION 14
Handling Out-of-Trend QC Results
SESSION 15
Implementing GLP in aDevelopment Laboratory
SESSION 16
Proper Documentation and SOPs
12:00 PM – Conference Close -Departure
You MUST mark the sessions and workshops you will be attending.Fax, E-mail, Mail, or Call Us Today. Payment is required at time of registration.Registration Form: Print Clearly or Attach Business Card
Complete this registration form, include payment in U.S. funds, and send to:Institute of Validation Technology • 200 Business Park Way, Suite F • Royal Palm Beach, Florida 33411-1742(561) 790-2025 or (800) 276-4242 (U.S. only) • Fax: (561) 790-2065 • E-mail: [email protected]
PRE-CONFERENCE, HALF-DAY, INTERACTIVEWORKSHOPS
Monday, August 16, 20048:30 AM – 12:00 PM . ………………………… $795.00A ■■ B ■■ C ■■ D ■■ (Choose one)
MAIN CONFERENCEMonday – Wednesday, August 16-18, 2004
■■ Main Conference ………………………… $1895.00
Monday, August 16, 200412:00 PM – 5:00 PM – General Sessions
Tuesday, August 17, 20048:30 AM – 12:00 PM – Half-Day Interactive WorkshopsE ■■ F ■■ G ■■ H ■■ (Choose one)
1:15 PM – 5:30 PM – General Sessions
Wednesday, August 18, 20048:30 AM – 12:00 PM – Half-Day Interactive WorkshopsI ■■ J ■■ K ■■ L ■■ (Choose one)
OPTIONAL DINNER WORKSHOP………… $50.00■■ Tuesday, August 17 (must pre-register to attend)
Method of Payment:
Please note that payment is required in advance of the conference. Please make checks
(in U.S. funds drawn on a U.S. bank) payable to Institute of Validation Technology.
Confirmation of your registration will be sent. Full payment must accompany registration
form. Registrations received without payment will not be processed.
Cancellations/Substitutions:
Your registration form may be transferred to a member of your organization at any time.
Requests for cancellations (by mail or fax) must be received by June 9,2004 in order to
receive credit for attending another IVT event.Please be aware that cancellations will not
be accepted after that date.All cancellations are subject to a $325.00 processing fee. IVT
reserves the right to cancel an event. IVT is not responsible for any airfare,hotel,or other
costs incurred by registrants.Speakers subject to change without notice.
■■ The Ultimate Passport $2,595.00The Passport Package includes:
• One Pre-conference Workshop on Monday
• Full Main Conference Monday,Tuesday, and Wednesday
• Four Post-conference Expanded Sessions Wednesday & Thursday
• Dinner Workshop (must pre-register to attend)
• All Networking and Cocktail Receptions
Attend the entire eventat this best value price!
Monday, August 16, 2004 – Pre-ConferenceWorkshops A-D $795 $_______________
Wednesday, August 18 and Thursday, August 19, 2004– Post-Conference Expanded SessionsSessions 1-16 ____________ X $395 = $ _______________(Choose up to four)
Monday – Wednesday, August 16-18, 2004 Main Conference $1,895.00 $_______________
Dinner Workshop $50.00 $_______________
TOTAL Enclosed: $ _______________
The Ultimate Passport $2595.00 $_______________(Please check the boxes of the workshops and sessions you wish to attend. )
✹ Multiple Registrations: Send three attendees and the fourthis FREE!
For hotel information see page 11.
Hear from 32 LaboratoryExperts including 2 Former FDA Officials and 17 Pharmaceuti-cal/Biotechnology Manufac-turers and Contract Labs…
• AstraZeneca Liquid ProductionSweden
• AstraZeneca Pharmaceuticals • Aventis Pharma Deutschland
GmbH• BD Medical Systems• Celgene Corporation• Chemir Pharma Services• Covance Laboratories Europe• DPT Laboratories• Eli Lilly and Company• G&W Laboratories, Inc.• GE Healthcare
