Presented by: Meena Chettiar SySy o snovis SuSu g … Presentation.pdf`Presented by: Meena Chettiar `SySy o snovis SuSu g ca srgicals,,ate o Baxter Bio ... design history of a finished

CBA Presentation by Meena Chettiar, MNASQ Summit

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Presented by: Meena Chettiar Synovis Surgicals, Baxter Bio SurgerySy o s Su g ca s, a te o Su ge yTues, 02/26/13

WELCOME and Are You in The Right Conference Room?

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Welcome and quick intro

Purpose of your presence here: Quick poll of your expertise

and goal

ASQ Certifications and CBA: for Medical Device

Professionals

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Professionals

Why is CBA the right/wrong certification

for you?Your questions and what next for you to become

CBA certified


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When planning for a year, plant corn. When planning for a decade, plant trees. When planning f l f d d l ”for life, train and educate people.”–Chinese proverb

So, here we are training you on what the BOK for CBA entails so you can decide if this is indeed the right career move for you!indeed the right career move for you!

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B.S; Chemistry, University of Madras, IndiaM.A.Sc : Chemical Engineering, University of B i i h C l bi C dBritish Columbia, CanadaM.S.RAS: Regulatory Affairs for Medical devices, St. Cloud State, USA10+ years at Agriculture and Health Canada in Calgary and Winnipeg, Canada4 years at Land O’Lakes, Scientist and Supervisor10 t T Ph i Ed P i i MN10 years at Teva Pharma in Eden Prairie, MN as Lab Supervisor, Manager; Completed MS RAS for Devices through SCS, Maple GroveNow: at Synovis-Baxter as Lead Auditor

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The body of knowledge comprising the certification exam is presented in the following modules:1. Auditing Fundamentals & Guidelines (ISO 19011 & GHTF)g ( )2. CFR 820 & ISO 13485 Quality System Regulations3. Supplier Quality Audits4. Design Control/Risk Management5. Software Development Guidelines6. Quality Tools7. US Regulations8. European Regulations

Bi tibilit9. Biocompatibility10. Sterilization/Environmental Controls11. QSIT – Quality System Inspection Technique

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4 hour exam In March & Oct, Multiple Choice, Open Book exam, 135 questions: 3-12

h f i /R i bmonths of review/Review courses by MNASQ/ASQ LI

Auditing Basics, Techniques and Inspection Processes for Medical devices: 34QMedical Device Laws & Regulations, QSR, g , Q ,MDD & Global Requirements 47QBio Medical Technical Knowledge: 40QQuality Techniques: 14Q

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M t ll f i fCreate (Synthesis)

• Mastery, recall of info

• Understand, summarize, differentiate

• Relate, skills and knowledge on the job

Apply (Application)

Evaluate (Evaluation)

Analyze (Analysis)

Understand• See patterns, hidden

• Synthesize and Evaluate,

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Understand (Comprehension)

Remember (Knowledge)


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Typical Sample Question #1• Audit Team Members are responsible for which two of the following?• Audit Team Members are responsible for which two of the following?

• I. Initiating the audit

• II. Remaining within the scope of the audit

• III. Compiling and analyzing evidence

• IV. Recommending specific corrective actions

a) I and III, b) I and IV, c) II and III, d) II and IV

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Internal First PartyBy the

organization for the organization

ExternalSecond Party

On a supplier by a customer

On an organization by i ti th t

the organization

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Third Party

an organization that is independent of the

supplier-customer relationship


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National or International standards: 21 CFR at o a o te at o a sta da ds C820, ISO 13485:2003Customer specificationsContracts, Industry codes and standardsGuides and handbooksPurchase ordersLaws and regulations

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Procedures’ parameters agree with validation? Design Validation?gCAPAs / Deviations?, Employee trainingDocumentation current/Controlled?Environmental tests? DI water? Instrument calibration, Rejected materials. Why? NCMR? Labeling controlWhy? NCMR? Labeling controlCustomer complaints, Follow up?

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Qualitative or quantitative records Gaps in quality system based on observation, Gaps qua ty syste based o obse at o ,measurement, or test, and which can be verified. System failuresGaps between procedures and practices for building the device, testing, labeling and packagingCorrelate to regulations

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Corrective action is…◦ Action taken to eliminate the causes of an existingAction taken to eliminate the causes of an existing

nonconformity, defect, or other undesirable situation in order to prevent recurrence.

Preventive action is…◦ Action taken to eliminate the causes of a potential

nonconformity, defect, or other undesirable situation in order to prevent occurrencesituation in order to prevent occurrence

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ISO 19011:Guideline for Quality and/or Environmental ISO 19011:Guideline for Quality and/or Environmental Management Systems AuditingGlobal Harmonization Task Force: GHTF-SG4 Auditing Guidelines◦ SG4(99)28, Guidelines for Regulatory Auditing of

Quality Systems◦ GHTF SG4(99)14, Audit Language Requirements( ) , g g q◦ GHTF SG4(00)3, Training Requirements For Auditors

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Assess manufacturer’s QMS and determine implementation effectivenessimplementation effectiveness

Understand regulations and applicable standards specific to QMS/medical device for its market

Understand user needs, intended use and risks associated with medical devices

Assess design, manufacturing processes and technologies utilized, Software, cleanroom etc.;

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Quality Systems Regulations and Standards:• General Provisions, Quality System

Requirements, Design Controls, Document Controls, Purchasing Controls, Identification and Traceability, Production and Process Controls , Acceptance Activities, Nonconforming product, Corrective and Preventive Action Labeling and Packaging C l H dli S Di ib i dControl ,Handling, Storage, Distribution and Installation Records Servicing Statistical Techniques

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• ISO 13485 Medical devices – Quality SO 3 85 ed ca de ces Qua tymanagement systems – Requirements for regulatory purposes• Intended to facilitate harmonized medical

device regulatory requirements for QMS• Requirements, are specific to organizations

providing medical devices, regardless of product type or size

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Requirements FDA QSR ISO 13485Planning 820.30(b) 7.3.1g ( )Input 820.30(c) 7.3.2Output 820.30(d) 7.3.3Review 820.30(e) 7.3.4Verification 820.30(f) 7.3.5Validation 820.30(g) 7.3.6D&D Ch 820 30(i) 7 3 7D&D Changes 820.30(i) 7.3.7Transfer DHF 820.30(h), 820.30(j) FDA QSR only

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Procedures to control NCMs, product from suppliers and in process products pp p p

(21 C.F.R. §820.90) Unique for Device world!

Proper disposition of NCMs to ensure the S&E of devices that are distributed for use.

Procedures for identification, documentation,Procedures for identification, documentation, evaluation, segregation and disposition of

NCMs.

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21 CFR 820.12021 CFR 820.13021 CFR 820.14021 CFR 820.15021 CFR 820.16021 CFR 820.170DHR: A compilation of records for theDHR: A compilation of records for the design history of a finished device. 820.3 (e); DMRs: Recipe for device build

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Function/PerformanceRegulatory & LegalRegulatory & LegalInformation from similar designsIdentified RisksPackaging & LabelingHuman Factors & BrandingSoftware

f & Q l

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Manufacturing & QualityInstallation & ServicingSafety & Environmental


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• ISO13485: The organization shall establishISO13485: The organization shall establish documented requirements for risk management throughout product realization. Records arising from risk management shall be maintained. References ISO 14971 as standard to use for risk management.g

• ISO 14971: Standard for the application of risk management to medical devices

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Development planning

Requirements analysis

Architectural design

Detailed designSoftware unit

implementation and verification

Software integration and

integration testing

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Software system testing Software release

◦ Be validated.◦ Protect the records to ensure its accuracy and

allow the availability during the retention period.◦ Allow access only to authorized users.◦ Have an audit trail.◦ Assure the completeness of the predefined

sequences.◦ Usage of mechanisms to verify accuracy and g y y

validity of info.◦ User training in system operation & commitment

to security

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1. Data Collection Tools, Data Analysis2. Quality Improvement ToolsQua ty p o e e t oo s3. Lean Concepts4. Process Capability5. Qualitative and Quantitative Analysis6. Sampling Techniques7. QSIT Sampling Plans7. QSIT Sampling Plans8. Statistical Techniques

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Device classifications: Class I,II, IIIAdulteration (Section 501 of Act)du te at o (Sect o 50 o ct)

• In general, based on device requirements and specifications and primarily relates to contamination.Misbranding (Section 502 of Act)

• In general, based on labeling and claims (e.g., incomplete, misleading, false, etc.

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IVD: Reagents, instruments, and systems intended for use in diagnosis of disease or gother conditions, to cure, mitigate, treat, or prevent disease or its progression.Product specs include performance and physical characteristics, microbiological quality, and chemical compositionIVDs have unique requirements

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Minimum requirements for reporting:Minimum requirements for reporting: contents are specified in 21 CFR 806.10(c)Record RetentionProduct recallsMedical Device Tracking: 21 CFR 821 implements section 519(e) of the Actimplements section 519(e) of the Act

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FDA 820.3(b) Complaint:Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution.

This process is different for EU MDD

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Active Implantable Medical Devices Directive 90/385/EEC (AIMD)In Vitro Diagnostic Directive 79/98/EC (IVDD)Medical Devices Directive 93/42/EEC (MDD)Active Implantable Medical Devices Directive 90/385/EEC (AIMD)European New Approach: Various Relationships within EU Manufacturers

CE marking, Conformity assessment routes

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Harmonized standards with particular relevance to QMS audits include:

• Quality Assurance System Requirements:EN ISO 13485 (EN ISO 9001 may also be utilized)

• Risk Management: EN ISO 14971, Packaging: EN ISO 11607• Labeling/DFU content: EN 980, EN 1041• Biocompatibility: EN ISO 10993 series• Sterilization:• Sterilization:

EN ISO 11135 (EO)EN ISO 11137 (Gamma)EN ISO 11134 (Moist Heat)

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Use of ISO 10993-1:2003 (now 2009) and FDA Blue Book Memorandum #G95-1. Approach taken by both is based on 1) type of tissue contact and 2) Duration of contact.Moist Heat, Ethylene OxideRadiationIncludes gamma and electron beamISO 14644-2 for Clean room compliance

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BOK: Can everything be studied to pass the exam? May be…y

Experience really helps integrate the material and correlate to the real world of medical devices. If you are in the device industry/ want to be or a supplier to Medical Device

CBA ill b !arena, CBA cert will be a great career move!

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CBA vs CQA?Device world vs Pharmae ce o d s a aDevices vs Food, Nutraceuticals?Device regulations: US vs ROW?MNASQ will offer certification prep.sessionsfor Oct 5th CBA exam for the 1st time!What Next FOR YOU????

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Pl. fill in feedback form! THANK YOU!

Documents

Presented by: Meena Chettiar SySy o snovis SuSu g … Presentation.pdf`Presented by: Meena Chettiar `SySy o snovis SuSu g ca srgicals,,ate o Baxter Bio ... design history of a finished