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Non-conformities and Containment
28th, August 2010
Hotel Fortune Select Manohar, Hyderabad
ISPE Indias YPEP
(Young Pharmaceutical Professionals Education Programme)
OnNon-conformities and Containment
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Under the auspicious of GCLP COP and Local Containment COP, ISPE
has pleasure in announcing
this one day training programme for young pharmaceutical
professionals.
Who will benefit
Laboratory analysts/technicians, Production and engineering
staff, QA staff Supervisory staff from all Operational areas.
Non-conformities in laboratories and production floors are
important events that need to be investigated
in detail and documented without ambiguity. It is a regulatory
expectation that all non-conformities are
investigated in detail and corrective and preventive actions are
put in place. CAPAs need to be appropriate
for the non-conformities and need to be followed up till closed
out. Experts from industry and regulatory
agencies will share their experiences and also discuss current
quality system related expectations as well as
regulatory expectations in these areas.
Containment is of great importance to pharmaceutical manufacture
both from the point of product quality
as well as patient safety. Containment is also important from
the operators perspective. Demonstration
that pharmaceutical products are free from cross contamination
is a GMP and regulatory expectation.
Experts from pharmaceutical and support industry will share
their experiences in handling containmentissues through case
studies and presentations.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering,
is the Society of choice for 25,000
pharmaceutical science and manufacturing professionals in 90
countries. ISPE aims to be the catalyst for
Engineering Pharmaceutical Innovation by providing Members with
opportunities to develop technical
knowledge, exchange practical experience, and collaborate with
global regulatory agencies and industry
leaders, Founded in 1980, ISPE has worldwide headquarters in
Tampa, Florida, USA; its European office
in Brussels, Belgium; its Asia Pacific office in Singapore.
Visitwww.ISPE.orgfor additional Society news
and information.
For Registration or Sponsorship Opportunities please
contact:
Ms. Kavita Rao, Affiliate Manager.
Email:[email protected]
http://www.ispe.org/http://www.ispe.org/http://www.ispe.org/mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.ispe.org/
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Schedule Venue:Hotel Fortune Select Manohar ,Hyderabad
Saturday, August 28 2010
0830-0900 Hrs Registration Ms Kavita Rao, Affiliate Manager,
ISPEIndia
0900-0915 Hrs Introduction to ISPE India Affiliate Mr. Gopal
Nair, Vice Chairman, ISE India
0915- 1000 Hrs Dealing with non-conformities in
manufacturing
Mr. Kapil Bhargava, Director ISPE India
and Retired Dy Drugs Controller, CDSCO,
Mumbai
1000-1030 Hrs Tea / Coffee
1045-1130 Hrs Dealing with non-conformities in
laboratories
Mr. ARM Rao, Vice President, Aurobindo
Pharma Ltd, Hyderabad
1130-1215 Hrs CAPA management Mr. R Raghunandanan, Director,
ISPE
India and Pharma Consultant, Mumbai
1215-1245 Hrs Open session All
1245-1345 Hrs Lunch
1345-1430 Hrs Introduction to Containment Mr. S M Mudda, ISPE
Director and
Executive Director, Operations, MicroLabs Ltd, Bangalore
1430-1515 Hrs Containment Case study Mr Sunil Singhai, Director,
Mfg, Dr
Reddys Lab, Hyderabad
1515-1545 Hrs Tea / Coffee break
1545-1615 Hrs Containment Solutions to
Pharmaceutical Manufacturing
Mr. P K Kulkarni, Chief Executive Officer,
Technolutions Projects Pvt.Ltd.
1615-1645 Hrs Case study on Penicillincontamination Mr. S M
Mudda, ISPE Director andExecutive Director, Operations, Micro
Labs Ltd, Bangalore
1645-1715 Hrs Open session All
1715 Hrs Close and distribution of certificates
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Registration form for program onNon-conformities and
Containment
Registration fees:
Rs. 1500/- ISPE Member/Non-Member Event Date: August 28
2010Venue: Hotel Fortune Select Manohar,
Old Airport Road, Begumpet, Hyderabad
Registration
FormName(Dr./Mr./Mrs./Ms.):________________________________________________________________________
(Surname) (First) (Middle)
Designation:___________________________________________________________________________________
Organization:__________________________________________________________________________________
Address of
Correspondence:______________________________________________________________________
_____________________________________________________________________________________________
___________________I____________________________I_____________________________________________
City Pin State
_____________________I_______________________I__________________I_____________________________
Phone (board) Phone(direct) Fax Mobile
Email:________________________________________________________________________________________
Area of
Intrest:_________________________________________________________________________________
_____________________________________________________________________________________________
Payment Details: Cheque payable at Mumbai /DD no &
Date:___________________________________________
Issuing Bank, Address & Amount:
_________________________________________________________________
Payment must be made through Cheque/DD payable at Mumbai in
favor ofISPE India Affiliate, at the mailing address. Thecomplete
registration form is to be sent along with the payment.
Send your application to : ISPE India Affiliate,1001 Dalamal
House,10th Floor, Nariman Point, Mumbai 400 021
Terms & Condition:
1. Delegates may be substituted at any time by registrants.
2. No refund will be given on cancellations, after the payments
have been received.
3. ISPE will not be responsible for any loss or damage,
alteration or cancellations from your organization as a result
ofsubstitutions.
