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Training
Gallery &
​Review

List of Training / 2016

JULY
20-21 July : Transition to ISO13485 : 2016 Quality Management System, Penang

JUNE
10, 17 and 18 June : ISO13485 :2003 and ISO 9001 : 2008 Internal Auditor Training, Selangor
1-2 June : Medical Device Manufacturing Process Validation, Penang
1 June :  US FDA Quality System Inspection Technique (QSIT):  21 CFR 820 Inspectional Technique, Selangor

MAY
30-31 May :  21 CFR Part 820 Quality System Regulation (QSR) and FDA CGMP Requirements For Medical Devices, Selangor


APRIL
11  -12 April : EtO Sterilization Training,   NCIA Biotech Centre, Penang  and Field Trip to Synergy Health, Kuala Ketil.  GALLERY


MARCH
21- 22 Mar  : Process Validation for Medical Device , G Gurney Hotel, Penang
28-29 Mar :  Process Validation for Medical Device ,  G Gurney Hotel, Penang

FEBRUARY 
1- 2 Feb :  ISO13485 Internal Auditing ,  G Gurney Hotel, Penang
22-23 Feb :  Medical Device Design Control,  G Gurney Hotel, Penang   
29 Feb : Process Validation for Medical Device , G Gurney Hotel, Penang

JANUARY 
4-5 Jan  :  CE Marking and EU Medical Device Directive,  G Gurney Hotel Penang
18-19 Jan : Malaysian Good Distribution Practice for Medical Device (GDPMD) , G Kelawai Hotel, Penang
26-27 Jan :  Introduction to the Essential Principles of Safety & Performance of Medical Devices,  Petaling Jaya, Selangor  GALLERY




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26-27 Jan : Introduction to the Essential Principles of Safety & Performance of Medical Devices
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1-2 Feb : ISO13485 Internal Auditing Training

List of Training / 2015

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8-9 Dec : Design Control Training
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29-30 Oct : Process Validation Training
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22-23 July : 21 CFR Part 820 Training
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24-25 June : Risk Management Training
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8-9 January : Process Validation Training

DECEMBER
3- 4 Dec : Medical Device Manufacturing Process Validation,  G Hotel Kelawai, Penang
7 Dec: Post-Market Surveillance, Vigilance & Adverse Event Investigation,  G Hotel , Penang
8 - 9 Dec :  Medical Device Design Control, E&O Hotel, Penang  GALLERY
10-11 Dec : GDPMD Internal Auditor Training. Empire Hotel Subang  GALLERY
14  Dec   : EtO Sterilization for Medical Devices, Aloft Hotel, Kuala Lumpur  
15- 16 Dec :  Medical Device Manufacturing Process Validation, Malacca


NOVEMBER
2- 3 Nov :  Risk Management in Medical Device Manufacturing, G Hotel, Penang
14 Nov : Medical Device Classification, Phillipines
23-24 Nov: FDA Good Manufacturing Practice (21 CFR Part 820), G Hotel, Penang
26-27 Nov :  Understanding ISO 13485:2003 QMS, OWG, Selangor  GALLERY
30 Nov & 1 Dec :  FDA Quality System Inspection Technique,  G Hotel, Penang
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OCTOBER
12 Oct : Medical Device Classification and Labelling, G Hotel Penang
13 Oct : ISO 13485 Quality Management System , G Hotel, Penang
19  20  Oct : ISO 13485 Quality Management System , G Hotel Penang
26-27 Oct : ISO 13485 Quality Management System , G Hotel Penang
29 - 30 Oct:  Medical Device Manufacturing Process Validation,  Aloft Hotel Kuala Lumpur GALLERY

SEPTEMBER
21-22 Oct : Post-Market Surveillance, Vigilance and Adverse Event Investigation, G Hotel Penang GALLERY/ REVIEW

AUGUST
11-12 August  21 CFR Part 820 Quality System Regulation and  FDA cGMP Requirements for Medical Devices, ​ E&O Hotel, Penang  GALLERY/ REVIEW
19-20 Aug : Understanding & Implementing GDPMD in Malaysia,  Aloft Hotel Kuala Lumpur  GALLERY
26-27 Aug :  Post Market Surveillance, Vigilance and Adverse Event Reporting for Medical Devices, Aloft Hotel Kuala Lumpur GALLERY

JULY
22-23 July : 21 CFR Part 820 Quality System Regulation and  FDA cGMP Requirements for Medical Devices,  Taiping, Perak
30-31 July : 21 CFR Part 820 Quality System Regulation and  FDA cGMP Requirements for Medical Devices,  G Hotel Gurney Penang  GALLERY/ REVIEW

JUNE
15- 16 June  : Medical Device Product Registration, G Hotel Kelawai, Penang  GALLERY
22-23 June : Medical Device Product Registration,  Aloft Hotel Kuala Lumpur GALLERY
24-25 June :  Risk Management in Medical Device Manufacturing, E&O Hotel Penang. GALLERY/ REVIEW

MAY
18- 19 May  : Code of Practice for Good Engineering Maintenance,  Kota Damansara, Selangor
​28-29 May : Medical Device Manufacturing Process Validation,  Sungai Petani, Kedah

APRIL
6 -7 Apr : CE Marking and EU Medical Device Directive , Northam Hotel, Penang
13- 14 Apr : ISO13485 Internal Auditing, Northam Hotel, Penang
20-21 Apr : Medical Device Sterilization, The Light Hotel, Seberang Jaya
27-28 Apr : Risk Management in Medical Device Manufacturing , Northam Hotel Penang
27-28 Apr :  Code of Practice for Good Engineering Maintenance,   Bayan Lepas, Penang

MARCH
2- 3 Mar : FDA Good Manufacturing Practice (21 CFR Part 820), Northam Hotel, Penang
16-17  Mar : FDA Quality System Inspection Technique (QSIT), Northam Hotel, Penang
23 Mar : Medical Device Classification and Labelling​, Northam Hotel, Penang
24 Mar : Post-Market Surveillance, Vigilance and Adverse Event Investigation, Penang
30 - 31 March :  ISO13485 Internal Auditing  , Aloft Hotel Kuala Lumpur  GALLERY/ REVIEW

FEBRUARY
9 - 10 Feb :  FDA Good Manufacturing Practice (21 CFR Part 820), Northam Hotel, Penang

JANUARY
8 - 9 Jan :  Process Validation for Medical Devices, Northam Hotel, Penang
12 Jan :  Process Validation for Medical Devices, Northam Hotel, Penang
13-14 Jan : Medical Device Design Control, Northam Hotel, Penang
26-27 Jan : Malaysian Good Distribution Practice for Medical Device (GDPMD), Northam Hotel, Penang






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