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
Fees:
- 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)
Cheque:
Payable to ‘ISPE Malaysia’
Address: C/O: SynertecAsia (M) SdnBhd
11thFloor, Block C, KelanaBusiness Centre
97, Jalan SS7/2, 47301 KelanaJaya, Selangor
Registration link:
https://docs.google.com/forms/d/1ylm1XWcVFSFTOe3Bc1_KjgJ3eSavjFGD02jBvlXia5w/edit
Notes on Registration:
Confirmation
- 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.
Cancellation
- 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
lfxin@npra.gov.my
Alyaa Ismail
Tel: 03-7801 8438
alyaa.ismail@npra.gov.my
Payment & HDRF (ISPE)
Rohani Mohammad
Tel: +6017 3381788
ispe.malaysia@gmail.com2017
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.
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Closing Date: 3 November 2017 MONDAY 13 NOVEMBER 2017 |
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08:00 –08:45 |
Arrival of Participant, Registration, Welcome Coffee and Networking |
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08:45 –09:00 |
Opening Speech and DoaRecitation |
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09:00 –09:45 |
Approaches for Biopharmaceutical Inspection -What to prepare Speaker: NPRA |
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09:45 –10:15 |
Morning Break and Networking |
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10:15 –11:00 |
Common Deficiencies Related to Biopharmaceutical Manufacturer Speaker: NPRA |
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11:00 –11:45 |
Cold Chain Inspection: Common Issues Speaker: NPRA |
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11:45 –12:30 |
Inspection of Critical Areas for Manufacturing of Drug Substance (DS) & Drug Product (DP) Speaker: NPRA |
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12:30–12:45 |
Q & A |
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12:45–14:00 |
Lunch Break |
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14:00 –15:00 |
Quality Control : Lot Summary Protocol Speaker: NPRA |
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15:00–16:00 |
SharingSession with Industry Speaker: Industry |
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16:00 –16:30 |
Q & A |
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16:30–17:00 |
End of Session & Afternoon Break |
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Lunch and all breaks shall be provided |
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