REGISTRATION

Registration Fee

213 Jalan Bukit Gambir

Bukit Jambul
11950 Penang
Special rates for Superior Rooms

On or before August 11, 2000 RM950.00

After August 11, 2000
RM1,100.00
Kindly make cheque payable to Malaysian

(Without Breakfast)
Single or twin occupancy at RM102.00 nett
per person

Organisation of Pharmaceutical Industries

** Additional RM15.00 nett will be charged

if breakfast is required.

Name
Title

Contact Person
Organisation
Address

Tel

Fax

Email
Cheque &
Amount
Enquiries

1.

Associate Professor Dr Yuen Kah Hay

Tel
: 604-656 9040
Fax
: 604-659 6517
Email : khyuen@usm.my

2.

Karen Ho
Tel
: 603-7727 3486
Fax
: 603-7727 3487
Email : mopi@tm.net.my

Kindly submit application to

Karen Ho
MOPI Secretariat
5B Lorong Rahim Kajai 13
Taman Tun Dr Ismail
60000 Kuala Lumpur
(Tel, fax & email as (2) above)

Mr Ben Quah
Tel
:
Fax
:
mobile
:
Email
:

604-6468000
604-6468343
019-3380888
bquah.ytlhp@ytl.com.my

Cancellation
A cancellation fee of 20% will be charged for any
notice of cancellation in writing to the organizer 7
working days prior to the commencement of the
workshop. Substitutes for registered participants are
allowed with written notice to the organizer at least
2 working days prior to commencement of the
workshop.
Reservation
The organizer reserves the right to make changes to
the venue, date, trainers and cancellation of the
workshop if warranted by circumstances beyond their
control.
Registration
Registration is confirmed upon full payment and
clearance of the cheques presented (if payment by
cheque)
for
the
workshop.

SUGGESTED ACCOMODATION
Vistana Hotel (near USM)
Malaysian Organisation of
Pharmaceutical Industries

Universiti Sains Malaysia

VALIDATION
OF
ANALYTICAL
METHODS WORKSHOP
August 28-29, 2000 at
Universiti Sains Malaysia,
Penang, Malaysia

Degradation
mechanism
of
pharmaceuticals
and
stability
indicating methods
Regulatory requirements by NPCB,
focusing mainly on HPLC
Atomic absorption spectroscopy will
be covered where relevant.

AIM OF THE COURSE

Associate Professor Dr Tan Soo Choon,

Universiti Sains Malaysia

To provide
better understanding of the elements
required for validation of analytical
methods
hands-on training on validation
calculations and presentation of
validation parameters
preparation of reports

Mr Yuki Hashi, Shimadzu (Asia Pacific)

Pte Ltd

WHO SHOULD ATTEND

JH\
Trainers
Associate Professor Dr Yuen Kah Hay,
Universiti Sains Malaysia

All laboratory executives (basic degree

holders) from the pharmaceutical industry
who have a working knowledge of HPLC
but not well versed and wish to upgrade
their knowledge on the given topics.

TOPICS
Linearity and range of detector
response
System suitability for conduct of
analysis
Limit of detection and quantification of
analytical method
Precision and accuracy
Ruggedness of assay method

The workshop will comprise

lectures and emphasis on
hands-on
practical
sessions. Participants are
required
to
carry
out
validation
of
methods
provided,
calculate
the
relevant
validation
parameters and prepare a
final report.
5 or 6 participants
assigned to a system.

are

Jointly Organised by

Malaysian Organisation of
Pharmaceutical Industries

Universiti Sains Malaysia

PROGRAMME

August 29, 2000

August 28, 2000

8.30 am

8.00 am
8.30

8.40

8.50
9.15
10.00

11.00

Registration
Welcome address by
Professor Ahmad Pauzi
Md. Yusof, Dean,
School of
Pharmaceutical
Sciences, USM
Address by Dr. Anis
Ahmad, Director of
Pharmaceutical
Services, Ministry of
Health, Malaysia
Tea & Refreshments
System Suitability of
Analytical Equipments
Method Validation and
Validation Parameters
of Analytical Methods

Regulatory
Requirements in
Analytical
Methodologies
12.00 pm Briefing of Hands-on
12.45
LUNCH
1.45
Hands-on Session on
Stability Indicating
Determination
3.30
Tea Break
3.45
Continue
5.00
End of First Session
8.00 pm DINNER at Vistana
Hotel

Hands-on Session on
Determination of
Validation Parameters
10.30
Tea Break
10.45
Continue
12.45 pm LUNCH
1.45
Calculations of
Validation Parameters
and Preparation of
Reports
3.30
Tea Break
3.45
Presentation of
Reports
4.45
Presentation of
Certificates and
Closing of Workshop
The course fee includes all
materials for workshop, 4 tea
break refreshments, 2 lunches &
1 dinner.