Risk Management through Electronic EnforcementRisk Management through Electronic EnforcementFDA Regulatory and Compliance SymposiumManaging Risks – From Pipeline to Patient
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software2
WHAT WE HAVE:A collection of manufacturing assets, products and technologies, that continue to be insufficient, and are by design, incapable of meeting the new challenges.
“We’ve had a few problems scaling up from the lab”Source: Medical Manufacturing, New Technology Imperative, James Bradburn, IBM Life Sciences
Life Science Manufacturing Realities?Life Science Manufacturing Realities?
Hazard
Risk
Potential source of harmProbability of the
occurrence of harm and theseverity of that harm.
IntroductionIntroduction
Hazard
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software4
Process of completing risk analysis and risk evaluation.Risk Assessment
Process through which decisions are reached and protective measures are implemented for reducing or maintaining risks within specified levels.
Risk Control
Risk remaining after protective measures have been taken.Residual Risk
Systematic application of management policies, procedures, and practices toward analyzing, evaluating, and controlling risk.
Risk Management
Based on the risk analysis, a judgment of whether a risk is acceptable based on societal values.
Risk Evaluation
Systematic use of available information to identify hazards and estimate risk.
Risk Analysis
Probability of the occurrence of harm and the severity of that harm
Risk
Potential source of harmHazard
DefinitionsDefinitions
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software5
Time to focus on Operational Excellence BasicsTime to focus on Operational Excellence Basics•• The cost of nonconformance extends beyond the direct costs of quThe cost of nonconformance extends beyond the direct costs of quarantining, arantining,
recall and rework, and fines to the destruction of brand equity.recall and rework, and fines to the destruction of brand equity.
•• Compliance strategy needs to be centrally developed and coordinaCompliance strategy needs to be centrally developed and coordinatedted——it it cannot be delegated to individual manufacturing sites.cannot be delegated to individual manufacturing sites.
•• The silos of quality and manufacturing must be broken down, and The silos of quality and manufacturing must be broken down, and a tighter a tighter integration of technology is required to sense, correct, preventintegration of technology is required to sense, correct, prevent, and report , and report effectively on manufacturing nonconformance events.effectively on manufacturing nonconformance events.
•• This problem is endemic to the pharma and life science industry.This problem is endemic to the pharma and life science industry. Disconnects Disconnects exist between different parts of the manufacturing product supplexist between different parts of the manufacturing product supply, regulatory, y, regulatory, and commercial functions.and commercial functions.
•• This is primarily a This is primarily a business process problembusiness process problem, as process requirements and , as process requirements and written procedures are not consistent throughout the organizatiowritten procedures are not consistent throughout the organization. But many n. But many pharma and life science organizations still have not reengineerepharma and life science organizations still have not reengineered their d their processes and organizational structures, relying on inconsistentprocesses and organizational structures, relying on inconsistent and manually and manually enforced compliance processes.enforced compliance processes.
Source: AMR Research, Compliance Trouble at Boston Scientific: An Isolated Incident or Part of a Growing Industry Liability?, February 09, 2006; Hussain Mooraj, Colin Masson, Roddy Martin
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software6
Multiple Compliance FrontsMultiple Compliance Fronts
Management of
Regulatory Compliance
Management of
Regulatory Compliance
Sarbanes Oxley
Sarbanes Oxley
HIPAAHIPAA21
CFR Part 11
21 CFR
Part 11
cGMPcGMP
Chief Compliance Officer
Regulatory Affairs
CAPA
Ex Com
QA/QC
CIO / ITFDAFDA
SECSEC
EPAEPA
OIGOIG
Source: AMR Research, Compliance Webinar, Roddy Martin, Joseph Vinhais, May 2004
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software7
How do you drive Governance and Compliance into Manufacturing?
Driv
e C
ompl
ianc
e
Time to Market
Share H
older Value
Who are the stake holders?Who are the stake holders?
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software8
Synchronizing change, execution, and enforcementSynchronizing change, execution, and enforcement
Compliance and process improvement are both based on following documented processes. Three mechanisms need to be coordinated:
Execute process —Train employees on the process, assess their performance, and, if necessary, take steps to improve their performance and adherence to it by improving training or other actions.
Enforce controls —Compliance adds a duty to control the process actively, perhaps by technical means, such as workflow. Companies must also audit the results to ensure that the controls work and detect any changes in the process, systems, or people that affect compliance. In addition, companies must constantly evaluate the controls to see if they are in fact meeting the desired control objectives.
Change process —For both compliance and business improvement purposes, companies need to evaluate their processes constantly and look for ways to improve them. This starts a new cycle of process design, followed by a project to implement the changed process.
Source: AMR Research, 2003
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software9
Medical Devices
ISO 14971, Application of RiskManagement to Medical Devices
Pharmaceuticals
cGMPs for the 21st CenturyA Risked-Based Approach
FDA’s 5 Part Strategic Plan
Quality Systems-based Inspections
1. Quality System2. Facilities & Equipment
system3. Materials System4. Production System5. Packaging & Labeling
System6. Laboratory Control
System
1. Quality System2. Facilities & Equipment
system3. Materials System4. Production System5. Packaging & Labeling
System6. Laboratory Control
System
1. Management Responsibility2. Design Control3. CAPA4. Production and Process
Control5. Records/Document Change
Controls6. Materials Controls7. Facilities & Equipment
Controls
1. Management Responsibility2. Design Control3. CAPA4. Production and Process
Control5. Records/Document Change
Controls6. Materials Controls7. Facilities & Equipment
Controls
1. Efficient Science-Based Risk Management
2. Patient & Consumer Safety
3. Better Informed Customers
4. Counterterrorism5. A Strong FDA
1. Efficient Science-Based Risk Management
2. Patient & Consumer Safety
3. Better Informed Customers
4. Counterterrorism5. A Strong FDA
cGMP CompliancecGMP Compliance
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software10
Source: ISO13485:2003 – An Overview (Bangkok, Thailand, June 2005), Gunter Frey, GHTF SG3
Global Medical Devices - Quality System RequirementsGlobal Medical Devices - Quality System Requirements
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software11
ICH Q9 Quality Risk ManagementICH Q9 Quality Risk Management
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software12
Implementation ofRisk Control
Measures
Culture on RiskCommunication
RMPolicy
An Integrated RiskManagement Process
(for all phases of the life of the product)
TrainingOf
Personnel
PostProductionMonitoring
RiskGraph
ResidualRisk
Risk Hazard
Cause
VerificationOf
Effectiveness
Source: ASQ Biomedical 09 December 2004, Alfred M. Dolan
EU14971:2003 Corporate Risk Management ProgramEU14971:2003 Corporate Risk Management Program
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software13
Low impact Medium impact High impact
Select good IT practice
Select generic & specific controls
Select generic controls
Periodic review and evaluationStep 5
Step 4
Identify generic hazards
Assess severity & likelihood
Identify generic & specific hazards
Assess probability of detection
Derive risk priorityConsider risks
Identify the electronic records and signatures
Assess impact of records and signatures
Step 3
Step 2
Step 1
The GAMP 4 Risk Model for Electronic Records and Electronic Signatures (ERES)
Source: FDANews, 2005
GAMP 4 and Part 11GAMP 4 and Part 11
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software14
GHTF Risk Management Activities in Design & DevelopmentGHTF Risk Management Activities in Design & Development
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software15
Source: GHTF. 2005
How risk management can be integrated into the CAPA processHow risk management can be integrated into the CAPA process
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software16
Risk Analysis• Intended Purpose Identification• Hazard Identification• Risk Estimation
Risk Evaluation
• Risk Acceptability Decision
Risk Control• Options analysis• Implementation• Residual Risk Evaluation• Overall Risk Acceptance
Post-production Information• Post-production experience• Systemic Procedures• Identification of new Hazards• Change Control & Feedback Loop
RiskAssessment
RiskManagement
Preliminary Hazard Analysis
Fault Tree AnalysisFunctional Analysis
Tolerability of RiskCost-Benefit AnalysisSocio/Ethical Analysis
FMECAHACCPHAZOPPAT
Six SigmaSPCCAPAComplaint Mgmt.
Aligning Risk Management ToolsAligning Risk Management Tools
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software17
Source: GHTF. 2005
Risk Chart for Communicating Internal Risk Management ActivitiesRisk Chart for Communicating Internal Risk Management Activities
Site Risk Potential (SRP) Site Risk Potential (SRP)
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software19
Product quality and performance achieved and Product quality and performance achieved and assured by design of assured by design of effective and efficient effective and efficient manufacturing processesmanufacturing processes
Product specifications based on mechanistic Product specifications based on mechanistic understanding of how formulation and process understanding of how formulation and process factors impact product performancefactors impact product performance
Continuous Continuous "real time" assurance of quality"real time" assurance of quality
Source: The Process Analytical Technology Initiative: PAT and the Pharmacopeias, Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Science CDER, FDA
Desired StateDesired State
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software20
all critical sources of variability identified and explained
variability managed by the process
product quality attributes can be accurately and reliably predicted
product specifications based on understanding of how formulation and process factors impact product performance
Source: PDA, PAT & Risk Based Initiatives, Implementation Issues: C. Cambell
Know your processes!Know your processes!
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software21
Materials
MethodsMan
MediumMachine
Measurement
Input Process OutputManagement
Source: PDA, The Harmonized PAT Solution: Application of Risk-Based Tools & PAT Strategies in Pharmaceutical Product Manufacture: J. Priem
Process Variation - Seven (7) M’sProcess Variation - Seven (7) M’s
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software22
INPUTS
(x)
Machine
Methods
Measure System
Prior Ops
Materials
Man
Machine - Equipment
Method - Process
Medium - Environment
Materials
Measurement
Man - People Inputs to the process Inputs to the process control variabilitycontrol variability
of the outputof the output
Output
y = f(x)y
Variability - source of the “Process” risks to the product
Source: Risk Reduction in Pharmaceutical Manufacturing using Process Analytical Technology, Brian Davies, Thermo Electron Corporation
Sources of VariabilitySources of Variability
Example50 Products
X10 Operations
X10 Orders per Year
X10 Lots/Batches/Units per Order
X12 Months (30 days per order)
X10 Transactions per Unit per Operation
=6,000,000 Transactions per year
3.43.499.999799.9997(top companies)(top companies)
+/+/-- 6 sigma (near 6 sigma (near perfect)perfect)
23323399.9767099.97670+/+/-- 5 sigma5 sigma
6,2106,21099.37999.379+/+/-- 4 sigma4 sigma
66,81066,81093.3293.32(most companies)(most companies)
+/+/-- 3 sigma3 sigma
308,700308,70069.1369.13+/+/-- 2 sigma2 sigma
697,700697,70030.2330.23+/+/-- 1 sigma1 sigma
Defects per Defects per OpportunityOpportunity
(traditionally PPM)(traditionally PPM)PercentPercentSpec LimitSpec Limit
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software23
Work Processes
AbnormalNormal
Non Value Add
UnnecessaryNecessary
EliminateReduce
Value Add
Flow
eliminate the abnormal and the unnecessary non- value added tasks
reduce the non-value added but necessary, e.g. regulatory
place the value-added processes into a natural sequence
Evaluation of Process StepsEvaluation of Process Steps
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software24
Value-creating tasks: Actions necessary for making products, such as welding or drilling.
Incidental work: Actions necessary to make products, but that don’t create value from the customer’s standpoint. Such actions include reaching for a tool or clamping fixture.
Waste: Actions that (a) create no value from the customer’s perspective and (b) can be eliminated from a process; e.g. walking to get tools that can be positioned within reach of a worker.
Value-Creating
Tasks12%
Incidental Work41%
Pure Waste47%
In a typical company, the greatest percentage of time is spent on tasks that are pure waste. Source: Lean Advisors Inc.
Source: Manufactures Get Lean to Trim Waste, William Leventon, Medical Device & Diagnostic Industry, September 2004
Identifying value added and non-value added
Value-Stream MappingValue-Stream Mapping
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software25
IncomingMaterials.
SpecificationsRelevant to
“Process-ability”
Incoming material attributesused to predict/adjust
optimal processing parameterswithin established bounds
(more flexible bounds)
PACPACPACPAC
PACPAC
PCCPPCCP
LTLTCMCMITIT
Direct or inferentialassessment of quality
and performance (at/on-line)
Control of process criticalcontrol points (PCCP).
Process end point (PEPs’) rangebased on “performance” attributes.
PEP’s
Chemometrics (CM)and IT Tools
for “real time”control and decisions
At-lineIn/On-Line
Process AnalyticalChemistry Tools Laboratory
or othertests
LTLT
Development/Optimization/Continuous Improvement(DOE, Evolutionary optimization, Improved efficiency)
MultivariateSystems Approach
RiskClassificationand MitigationStrategies
Source: ACPS, Process Analytical Technologies (PAT) Sub-Committee Report: T. Layloff, Ph.D
PAT Conceptual FrameworkPAT Conceptual Framework
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software26
Strength
PurityQuality
Identity
Potency
FailureMode
Cause Effect
Ishikawa
P o t e n t i a lF a i l u r e M o d e a n d E f f e c t s A n a l y s i s
( D e s i g n F M E A )_ _ S y s t e m_ _ S u b s y s t e m_ _ C o m p o n e n t
M o d e l Y e a r / V e h i c l e ( s ) :C o r e T e a m :
D e s i g n R e s p o n s i b i l i t yK e y D a t e :
F M E A N u m b e r :P a g e 1 o r 1P r e p a r e d b y : L e e D a w s o nF M E A D a t e ( O r i g . ) :
I t e m
F u n c t i o n
P o t e n t i a lF a i l u r eM o d e
P o t e n t i a lE f f e c t ( s ) o f
F a i l u r e
P o t e n t i a l C a u s e ( s ) /
M e c h a n i s m ( s )O f F a i l u r e
C u r r e n tD e s i g n
C o n t r o l sP r e v e n t i o n
C u r r e n tD e s i g n
C o n t r o l sD e t e c t i o n
R e c o m m e n d e dA c t i o n ( s )
R e s p o n s i b i l i t y& T a r g e t
C o m p l e t i o nD a t e
A c t i o n sT a k e n
A c t i o n R e s u l t sSEV
CLASS
OCCUR
DETEC
R .P .N .
SEV
OCC
DET
R .P .N .
P o t e n t i a lF a i l u r e M o d e a n d E f f e c t s A n a l y s i s
( D e s i g n F M E A )_ _ S y s t e m_ _ S u b s y s t e m_ _ C o m p o n e n t
M o d e l Y e a r / V e h i c l e ( s ) :C o r e T e a m :
D e s i g n R e s p o n s i b i l i t yK e y D a t e :
F M E A N u m b e r :P a g e 1 o r 1P r e p a r e d b y : L e e D a w s o nF M E A D a t e ( O r i g . ) :
I t e m
F u n c t i o n
P o t e n t i a lF a i l u r eM o d e
P o t e n t i a lE f f e c t ( s ) o f
F a i l u r e
P o t e n t i a l C a u s e ( s ) /
M e c h a n i s m ( s )O f F a i l u r e
C u r r e n tD e s i g n
C o n t r o l sP r e v e n t i o n
C u r r e n tD e s i g n
C o n t r o l sD e t e c t i o n
R e c o m m e n d e dA c t i o n ( s )
R e s p o n s i b i l i t y& T a r g e t
C o m p l e t i o nD a t e
A c t i o n sT a k e n
A c t i o n R e s u l t sSEV
CLASS
OCCUR
DETEC
R .P .N .
SEV
OCC
DET
R .P .N .
FMECA
0123456789
10
Qua
ntity
A. Very High B. High C. Moderate D. Low E. Remote
I. CatastrophicII. Critical
III. MarginalIV. Minor
Probability of Occurance
Severi
ty
Criticality Matrix
DOE
Multivariate Analysis
SPC
RawMaterial Dispensing Granulation Drying Milling Mixing Tabletting Coating
Source: ISPE-Boston, Feb. 2005
PAT ExamplePAT Example
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software27
Site Risk Potential
Product Process Facility
CD1 CD2 CP1 CP2 CF1 CF1
Top Level Components
Categories ofRisk Factors
Risk Factors(quantitative or qualitativevariables)
Dosage form; intrinsicchemical properties
Poor cGMP compliancehistory
Measuring; mixing; compression; filling
FDA’s SRP Hierarchy (Sept. 04)FDA’s SRP Hierarchy (Sept. 04)
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software28
SystemsDirect Indirect Non
gmp
gep gepgep
+
ComponentsCritical Non Critical
comm.
qual.
comm.
+
cGMP Impact Assessments
&
Source: PDA, PAT & Risk Based Initiatives, Implementation Issues: C. Cambell
Physical RiskPhysical Risk
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software29
Class-I Class-II Class-III
IntolerableRisk cannot be
justified except in
extraordinarycircumstances
UndesirableTolerable only
if risk reduction is impracticable or
the costs are grossly disproportionate
to the improvementgained
TolerableTolerable if the cost of the risk
reductionwould exceed the
improvement gained
NegligibleTolerable if the cost of the risk
reductionwould exceed the
improvement gained
IECFunctional Safety: safety-related systems
Class-IV
Source: PDA, PAT & Risk Based Initiatives, Implementation Issues: C. Cambell
Functional RiskFunctional Risk
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software30
111122LowLow
112233MediumMedium
223333HighHigh
Low ImpactLow ImpactMediumMediumImpactImpact
High High ImpactImpact
ProbabilityProbability
Risk ClassRisk Class
MMLLLL11
HHMMLL22
HHHHMM33
LowLowDetectionDetection
MediumMediumDetectionDetection
HighHighDetectionDetection
Risk PriorityRisk Priority
Risk ClassRisk Class
Class f (probability, impact) Priority f (class, detection)
Source: PDA, PAT & Risk Based Initiatives, Implementation Issues: C. Cambell
Process RiskProcess Risk
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software31
PhysicalRisk
C N
FunctionalRisk
IIIIII IV
ProcessRisk
M LH 0
StandardComponents
StandardOperations
StandardParameters
SRPMitigation
Plan
Source: PDA, PAT & Risk Based Initiatives, Implementation Issues: C. Cambell
Risk IntegrationRisk Integration
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software32
CNIIIIIIHML
IQ OQ PQ PV PAT QADQ
X X X X
FDA
Process Risk
FunctionalRisk
PhysicalRisk
X X X X
X X X X
X
X
Source: PDA, PAT & Risk Based Initiatives, Implementation Issues: C. Cambell
Risk DividendRisk Dividend
Electronic EnforcementElectronic Enforcement
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software34
Execution Systems Orchestrate ProductionExecution Systems Orchestrate Production
Machine Line Plant Enterprise
Controls
Parameters
Data ReadingsStatus
People
Shop Packet
Work Status
ProductionStatus
ERP
Product & process
data definitions
Product & process data
definitions
ProductionOrders
Execution System
Set points
Equipment
PLM/EDM
Manufacturing Process
Product & process
data definitions
TraceabilityInventory
Picklist
Consumption
PACPACPCCPPCCP
CMCMITIT
PEP’s
PAT
Source: IBM Life Sciences, James Bradburn
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software35
PLM CRMERP
Financials BOM OrderFulfillment Inventory
Automation and Data Capture
RawMaterial Machining Cleaning Assembly Testing Packaging
QMS AQP Auditing Training InspectionTest
NCR(CAR, SCARs)
CAPAComplaints
Service Oriented Architecture & Integration Framework
Process & Equipment Optimization Layer
Manufacturing Execution
BatchControl
LineMonitoring
Weigh &Dispense
Material Flow& Lot Tracing
ContainerManagement
Dat
a C
olle
ctio
n,
Rep
ortin
g, M
etric
s/K
PIs
Ala
rms
& E
scal
atio
ns
Stat
istic
al
Proc
ess
Con
trol
WIP
Tra
ckin
g
Equi
pmen
tM
anag
emen
t
Proc
ess
Plan
ning
Work Order Management
MBOM
Work Instructions & Procedures
Operator Tracking
(change, execution, and enforcement)O
pera
tiona
l/Tra
nsac
tiona
l Con
trol
Enterprise M
anufacturing Com
pliance
Risk Management “File”
Align Enterprise ApplicationsAlign Enterprise Applications
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software36
Initiate Containment
Action
Initiate Root Cause
Analysis
Initiate CAPA
Process
Request for CAPA Plan
Review CAPA Plan
CAPA Plan Approved?
Initiate Implementation
Implement&
Sign-Off
Verify Effectiveness
Close CAPA
PROCEDURE
REGULATIONClient
ReporterCRM Sys. Paper Trail begins,
Notifications to appropriate parties
Complaint Submission Process
AcknowledgementLetter to Customer
Issue a CAPA to Plant
ReviewEdit/Close
Regulatory Submission( Such as 30 day MDR5 day MDR, Summary)
Complaint Coordinator Process
Complaint Coordinator
Plant Complaint Coordinator
Closure LetterTo Client
SOP
CORPORATEPOLICY
Existing Regulatory Process ControlExisting Regulatory Process Control
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software37
Electronic EnforcementElectronic Enforcement
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software38
Regulatory/Compliance “Process” ManagementRegulatory/Compliance “Process” Management
• Start jobs based upon:• Web service external event• Web service start job request• Repository updates (filtered) from MES,
MCS or other data sources• Scheduled start
Multiple workflow paths depending on eventRun Rules and Reports for decision supportContext filtering and evaluationSynchronization with multiple start events or wait for events
Multiple responses possible depending on flow pathExecute web service calls to external systems such as MES, ERP, CAPA and othersExecute email, logging, exporting SQL, external applications, and other executions
Manufacturing Compliance Framework
• FDA Regulatory and Compliance Symposium© 2006 Brooks Software39
• GHTF, Implementation of risk management principles and activities within a Quality Management System, May 20, 2005
• FDANews, Introduction to GAMP Good Practice Guide: A Risk-Based Approach to E-Record Compliance, Per Olsson
• FDA, A Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century
• PAT & Risk-Based Initiatives: Implementation Issues; PDA New England - 08 Dec 2004, Cliff Campbell B.E., C.Eng
• The Harmonized PAT Solution: Application of Risk-Based Tools & PAT Strategies in Pharmaceutical Product Manufacture; PDA New England – 08 Dec 2004, Jeffrey A. Priem
• Process Analytical Technologies (PAT) Sub-Committee Report ACPS Meeting 21 October 2002, Tom Layloff, Ph.D.
• Risk Management, From Basic to Advanced; RAPS – 11 October 2004, Kevin P. Bassett; Matthias M. Buerger; Oliver P. Christ
• Importance and Impact of ISO 13485:2003, RAPS – 13 October 2004, Ed Kimmelman, JD
• Risk Management of Medical Devices: Implementation, ASQ Biomedical 09 December 2004, Alfred M. Dolan
• Implementation of Risk Management Principles within a Quality Management System, 09 December 2004, Kimberly Trautman
• ISO 14971:2000, Essentials 1st Edition, A practical handbook for implementing the ISO 14971 Standards for medical devices, Canadian Standards Association
• IEE Tolerability of Risk Framework hsc36, Health and Safety Briefings - October 2000
• FDA, A perspective on Risk Analysis for the GMP Initiative - April 2003, H. Gregg Claycamp, Ph.D., CHP
• Risk Reduction in Pharmaceutical Manufacturing using Process Analytical Technology, Brian Davies
• Risk-Based Method for Prioritizing cGMP Inspections – September 2004, Department of Health and Human Services U.S. Food and Drug Administration
• Pharmaceutical Manufacturing: New Technology Opportunities – 16 November 2001, G.K.Raju, Ph.D
• PAT Progress Report: 13 April 2004 ACPS Meeting, Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Science CDER, FDA
• Guidance for Industry, PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance DRAFT GUIDANCE
• Process Analytical Technology (PAT): What’s in a name? – 09 April 2004, D. Christopher Watts, Ph.D. Office of Pharmaceutical Science, CDER, FDA
SourcesSources
Thank YouThank YouJoseph [email protected]://lifesciences.brookssoftware.com
Top Related