AGENDA

Industry Training
That Held Back To Back With
5th ASEAN Medical Device Committee Meeting
and
Its Related Meeting

Day 1: Industry Training (October 4th, 2017)

Time SCHEDULE Speakers
09:00am - 10:00am Opening Ceremony
10:00am - 10:30am Registration and Coffee Break
PLENARY : Penetrate Regional Market Through ASEAN CSDT Implementation
- APACMed
10:30am - 11:00am AMDD overview and its benefits to industry, country and ASEAN region
- Regulator
11:00am - 11:30am Essential Principles of Safety and Performance of MD APACMed
11:30am - 12:00pm MD Risk Classification and Grouping Arrangement APACMed
12:00pm - 12:15pm Understand the Definition of MD, including Its Accessories and Spare Parts APACMed
12:15pm - 12:45pm CSDT and Good Registration Submission Practices APACMed
12:45pm - 1:45pm Lunch
PLENARY : Indonesia Registration Requirements
1:45pm - 2:15pm MD with Radio Frequency ID Regulators
2:15pm - 2:45pm MD which emit Radiation ID Regulators
PLENARY : Medical Device Post Market Surveillance
2:45pm - 3:30pm Post Market Surveillance : Complaint Handling, Adverse Event and Field Safety Corrective Action APACMed
3:30pm - 4:15pm Principles of Root Cause Analysis, Risk Analysis and CAPA APACMed
4:15pm - 4:30pm Coffee Break
PLENARY : Indonesia Practice Sharing for Post Market Surveillance
4:30pm - 5:00pm Mandatory Reporting - E-Report ID Regulators
5:00pm - 5:30pm Product Audit and Product Sampling ID Regulators
Day 2: Industry Training (October 5th, 2017)
Time SCHEDULE Speakers
08:30am - 9:00am Registration
Concurrent Session
Group 1 : Medical Device Quality & Safety
Group 2 : Implementation of ISO 13485
Assurance Through GDPMD Implementation
GDPMD definiton Product Lifecycle of MD and IVD
Special requirements for special products
Validation process (IQ, OQ, PQ)
09:00am - 10:30am specification APACMed

Quality Agreement and Warehousing Management Root Cause Analysis, Risk Analysis, and CAPA

Handling FSCA (e.g Recall, Field Safety Notice,

Supplier Qualification and Control
Shipment restriction)
10:45am - 11:00am Coffee Break
SHARING SESSION : Indonesia Experience
CDAKB : Indonesia experience in implementing CPAKB : Indonesia experience in implementing ISO
11:00pm - 12:00pm ID Regulators
GDPMD 13485
12:00pm - 1:00pm Lunch

1:00pm - 5:00pm Stakeholder Forum AMDC

 Please send your registration form not
later than August 29th, 2017
Email to :
5thamdccommittee@gmail.com

REGISTRATION FORM

Registration Details
Name (*Mr/Mrs) : __________________________________________________________________________
Company / Organization : __________________________________________________________________________
Title : __________________________________________________________________________

Full Address : __________________________________________________________________________

______________________________________________Postal Code __________________

Telephone / Mobile : Country Code___________Area Code__________Number___________________________

Fax Number : __________________________eMail___________________________________________

I Would Like to Register as (*Please Select the Category Bellow)

Indonesian Established Domestic Corporation IDR 5.000.000,- / Person

(PMDN, BUMN, Local Companies of GAKESLAB/ASPAKI Member)

Indonesian MNC, GAKESLAB/ ASPAKI Member IDR 6.500.000,- / Person

Foreign Corporation, Indonesian MNC Non GAKESLAB/ASPAKI Member USD 650,- / Person

Foreign Government Representative USD 500,- / Person

Note :

1. IDR 1.000.000,- (Local) or USD 100 (Foreigner) discount for Early Bird Registration by August 17th, 2017
2. IDR 4.000.000,- Registration Fee for 3rd person of same local companies (BUMN, GAKESLAB/ASPAKI Member)
3. IDR 5.000.000,- Registration Fee for 3rd person of same Indonesian companies non GAKESLAB/ASPAKI Member
4. Registration Fee Covers 2 days Training (4th & 5th October 2017) and Gala Dinner (4th October 2017)
I Would also like to Join Bromo Tour (*OPTIONAL)

BROMO PACKAGE TOUR

Indonesian Citizen / Local IDR 1.350.000,- / Person
Foreigner USD 120 / Person
Fee Includes Transportations, Snack, Breakfast, Lunch, Ticketing
*Limited Space, only for 120 Pax

PAYMENT METHODE :
Transfer Bank
IDR Currency USD Currency
Bank Name : Bank Central Asia Bank Name : Bank Central Asia

Branch : KCP ManggaDua Surabaya Branch : KCP ManggaDua Surabaya

Account Name : Nicky Johan Cahyono Account Name : Nicky Johan Cahyono

Account Number : 1070076213 Account Number : 1070076205

Swift Code : CENAIDJA

Note :
All banking charges, if any, are to be borne by the delegates
Please quote the 5th AMDC Meeting in the remittance document as the remittance message for our
Verification. Please submit the completed registration form together with the copy of remittance document
to: 5thamdccommittee@gmail.comOr email to ivanchristiawan@gmail.com

Important Note:
Registration fee is nonrefundable.
Meeting program is subject to change without prior notice.
The information provided in this form will only be used for processing your participation and
Communication with you on matters related to the 5thAMDC Meeting. If you wish to correct your personal
data, please email to 5thamdccommittee@gmail.com
Any copy of telegraphic transfer should be sent to 5thamdccommittee@gmail.com

Name& Signature Stamp & Date

Date