50% funded under the HRDF Industry Certification (INDCERT) Scheme

MEDTECH TECHNICAL COMPETENCY COURSE

Track Record: Class of 2018 Medtech Technical Competency Course

Medtech Technical Competency Course

Course Outline• ISO13485 Quality Management System and Internal Audit• 21 CFR Part 820 and QSIT• EN ISO14971 Risk Management• Biological Evaluations• Process Validation• Sterilization• Test Method Validation (Including Gauge R&R)• Design Control / Quality Function Deployment• Medical Device Classification, Labelling, EUMDR and CE Marking• Statistical Hypothesis Testing and Capability Analysis• Design of Experiments• Statistical Process Control• Change Control• MDA Regulations

Target ParticipantsThis training aims to train cross functional technical specialists.

Training Venue

Faber TowersAddress: Level 18, Tower 1, Faber Towers, Jalan Desa Bahagia, Taman Desa, Kuala Lumpur

TRAINERS’ PROFILES

Tony is a CE Marking Notified Body Auditor with over 24 years’experience in conformity assessment (product, process &systems). In this span of time, his experience throughout theentire medical device product lifecycle as well as all 3 medicaldevice regulatory phases has covered contemporary medicaldevice technologies. Tony shares his expertise vide the provisionof training, assessment & advisory services on regulatorycompliance to Regulatory Authorities, other government agenciesand the healthcare industry. In addition to being the co-Chair ofthe Work Group on Standards, he is also the MalaysianRepresentative to the Asian Harmonization Working Party

TONY LOWDirector of Quality Assurance & Regulatory ComplianceCommissioning Agents International

GOBU DEVARAJANAssociate Director, QA/RA,APAC Quality AssuranceMedical Global Business Unit, Ansell Melaka.

Mr Gobu possesses Master Degree in Electrical and ElectronicEngineering and Certified Manager of Quality/OrganizationalExcellence (CMQ/OE, Certified Quality Auditor (CQA) fromAmerican Society of Quality (ASQ). Certified Six Sigma Green Belt.He has more than twenty five years of working experience withextensive knowledge in the field of Quality Engineering, StatisticalAnalysis and Quality System Requirements.

He possesses excellent communication and presentation skills. He iscapable of designing, conducting training programs and performgap analysis according to QSR (21 CFR Part 820), ISO 13485, ISO9001, ISO 16949 and ISO 14971. MDD 93/42/EEC, CMDCAS andJPAL.

He was Quality Technical Manager at Teleflex Medical beforeassuming his current position at Ansell.

Lim is a Certified Six Sigma Master Black Belt. He has a Bachelor ofScience in mechanical Engineering and a Master in BusinessAdministration. He has over 20 years of working experience in Process,Quality System and Business Process Improvement in variety ofindustries including medical device industry. He has worked with and atsenior management level to improve process efficiency, implementeffective Lean manufacturing systems and improve profitability. He hascoached and consulted for Motorola University’s clients which haveembarked on the Lean Six Sigma Business Improvement Campaign.

In addition to consulting, he has trained Six Sigma and Lean Green andBlack Belts candidates in Australia, New Zealand, People Republic ofChina, India, Malaysia, Singapore, Indonesia and Thailand. He is currentlyalso serving as advisor to senior leadership for companies in variety ofindustries, some of which are multinationals (MNC) and medical devicemanufacturing company.

L.K. LIMDirector, NexMU

Harry Wong has over 18 years’ of professional work experience in

Quality Assurance of medical device, Ceramic Former and Metal

Stamping for Electrical, Electronics and Automotive industries. He

currently holds the position of Senior Manager, Global Complaint and

Risk Management, Global Quality Assurance in one of the global leaders

in protection solutions.

As the subject matter expert of risk management, he provides advice,

direction and training for Risk Management personnel across global sites

and facilities; ensuring their risk management process complies with all

necessary regulatory standards including QSR (FDA), MDD and ISO

requirements. He is responsible for developing the global harmonized

risk management SOP and tools which are implemented in the global

organization facilities and sites.

Harry Wong is also an ASQ Certified Quality Engineer and Lead Auditor

for ISO 9001 and ISO 13485 and has extensive involvement in mock

audits for global sites preparing for CCC, ANVISA, SEI and FDA.

HARRY WONG HON MENGSenior Manager, Complaint and Risk Management,Global QA at Ansell

Course Exam & Certificate

AMMI Medtech Examination Committee

Company Committee Members Position

Abbott Ms Kek Soo Ling Director, Quality

Ambu Ms Koh Seok Ling Sr QA/RA Manager

Ansell Mr Khor Siek Meng Sr Director, QA

Haemonetics Ms Gan Poh Siew Director, QA/RA, APAC

Course Exam

Certificate of Competency

Certificate of Attendance

Passing Mark: 60/100

Less than or 59/100

The selected employee should have at least 80% training attendance to

complete the course.

AttendanceCommitment

Company shall pay back 100% of the training course fee to AMMI

if the selected employee’s attendance is less than 80%.

<80%

>80%

Penalty

Attendance commitment letter from the AMMI member companies and trainees

Agreement betweenCompany & AMMI

Attendance Commitment

Terms and Conditions

Eligibility • All HRDF registered employers (AMMI members and non-members) are eligible to participate under the INDCERT scheme.

• Each employer can only train a maximum of 25 employees for the approved courses under INDCERT scheme.

Employee • Each employee is only entitled to attend one approved course under the INDCERT scheme.

ReplacementReplacement of trainee before the training • Replacement of trainees is allowed with 5 working days

notification before the training commences.

WithdrawalWithdrawal or replacement of trainee after the training commences • Replacement of trainees is not allowed if the trainees withdraw

after the training commences.

Timeline and Registration Process Flow

1) Pre-registration for Medtech Courses • Submit registration via AMMI Medtech website• https://ammi.com.my/medtech-2020/

2) Confirmation of registration• Successful registration will receive a confirmation from

AMMI.

4) Successful Application• Upon approval by HRDF, successful application will receive

a notification from HRDF.

5) Submission of Commitment Letter• Company shall submit signed Letter of Commitment to

AMMI before commencement of training.

3) Online Application via HRDF portal • Upon receiving the required documents from AMMI,

company can submit the application via HRDF portal (www.hrdf.com.my).

Registration Process:

Process Flow

www.ammi.com.my

Association of Malaysian Medical Industries (AMMI) Tel : +6010 4040 662Fax : +603 2178 4347

Email : secretariat@ammi.com.my

Contact: Ms Heng Ee Ling : 010 4040 662Ms Melissa Khoo : 016 4224 818Mr CS Ching : 012 4766 558