2017 Education Seminar Series:
GMP/GDP Inspection on Biopharmaceuticals 2017

Venue: Royale Chulan Damansara Hotel Petaling Jaya
Time: 8:00 am –5:00 pm

Who should attend:
Pharmaceutical & Biopharmaceutical Manufacturers
Biopharmaceutical Importers & Distributors


  • Ordinary ISPE Member: RM 650
  • Non ISPE Members: RM 850
  • Government Agencies & Academia ISPE Members: RM 450

Payment Details:
Bank transfer /deposit:
Account name : ISPE Malaysia.
Bank : United Overseas Bank (M) Berhad
A/C No.: 1623023449(Swift Code: UOVBMYKL)

Payable to ‘ISPE Malaysia’
Address: C/O: SynertecAsia (M) SdnBhd
11thFloor, Block C, KelanaBusiness Centre
97, Jalan SS7/2, 47301 KelanaJaya, Selangor

Registration link:

Notes on Registration:

  • Confirmation of registration email will be sent to participant afte rregistration fee has been made.
  • A copy of the Confirmation email is to be presented during registration on 13 Nov 2017.


  • No refund will be given upon cancellation. However,a replacement will be accepted at noadditional cost with consent of the Secretariat.

Closing Date: 3 November 2017

Enquiries: contact
Registration (NPRA)
Lim FeiXin
Tel: 03-7883 5572

Alyaa Ismail
Tel: 03-7801 8438
Payment & HDRF (ISPE)

Rohani Mohammad
Tel: +6017 3381788

Objective of Training:

  • Highlight the requirements of GMP and GDP on manufacturing and distribution activity of biopharmaceutical products.
  • To share NPRA’s experience during GMP and GDP inspection related to biopharmaceutical products.

Closing Date: 3 November 2017 MONDAY 13 NOVEMBER 2017

08:00 –08:45

Arrival of Participant, Registration, Welcome Coffee and Networking

08:45 –09:00

Opening Speech and DoaRecitation

09:00 –09:45

Approaches for Biopharmaceutical Inspection

-What to prepare

Speaker: NPRA

09:45 –10:15

Morning Break and Networking

10:15 –11:00

Common Deficiencies Related to Biopharmaceutical Manufacturer

Speaker: NPRA

11:00 –11:45

Cold Chain Inspection: Common Issues

Speaker: NPRA

11:45 –12:30

Inspection of Critical Areas for Manufacturing of Drug Substance (DS) & Drug Product (DP)

Speaker: NPRA


Q & A


Lunch Break

14:00 –15:00

Quality Control : Lot Summary Protocol

Speaker: NPRA


SharingSession with Industry

Speaker: Industry

16:00 –16:30

Q & A


End of Session & Afternoon Break

Lunch and all breaks shall be provided