ISPE India Affiliate
Presents
Young Pharmaceutical Professional Education Program (YPEP)
On
Quality Management Systems & Schedule L1
26th February, 2011, Best Western Royal Park Hotel, Baddi
Who will Benefit ?
Quality Management
System
* Laboratory Analyst
and Technicians
* Production and Engineering Staff
* Q.A & Q.C Staff
Deviation Handling
* Warehousing Staff
Corrective and Preventive
Actions
* Regulatory Professionals
Change Control Process
For Registration &
Sponsorship Contact:-
Good Documentation
Practices
Mr. Shekhar Rawtani
1001 Dalamal House, Nariman Point,
Mumbai - 21
Environmental Monitoring
Training Fee: INR 1500
Payable by Cheque/D.D Only*
(Favor of “ISPE INDIA AFFILIATE” payable in Mumbai)
+91 22 3008 9475/76
admin@ispeindia.org
Truly international
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-forprofit association dedicated to educating and advancing pharmaceutical manufacturing
professionals and their industry. Founded in 1980, today ISPE serves 25,000 members in 90
countries.
ISPE has been recognized by the White House and regulatory bodies, globally, especially the
US FDA, EMEA, SPIC, DCGI and TGA, for contributions to the industry.
Schedule L1:Laboratory controls are critical aspects of Good Manufacturing Practices as the concept
includes consistent manufacturing and control too. The emphasis of GMP compliance and audits is placed
. Good Quality Control Laboratory Practices
on
The new Schedule L1 on GLP has become mandatory from November 1, 2010. It is important at this point
of time to understand, revisit and refresh GLP with new dimensions of legal and industrial compliance.
Understanding this need of the industry and in line with our mission "synergy for Success", this training
program on the above subject shall be helpful in understanding the complete requirements of Laboratory
Controls as a part of cGMP requirements as well as planning sustainable compliance in the area of GLP
Quality Management Systems:
Deviation Handling & CAPA:
FDA's Quality System Guide and ICH Q10 clearly emphasizes the
increasing relevance of a proper deviation management and CAPA.
As indicated in ECA's Warning Letter Report, production record review is one of the most frequent GMP
deviations observed by the FDA. In the fiscal years 2008, 2007 and 2005, observations regarding this subject
were No. 1 in the ranking of cited GMP deficiencies. After a closer look at these citations, it becomes obvious
that most observations are caused by failures in deviation management and CAPA. In most cases,
deviations were noticed by the pharmaceutical company but no sound investigation was performed and no
consequences were defined.
Change process control within Quality management systems (QMS) is a formal process used to
ensure that changes to a product or system is introduced in a controlled and coordinated manner. It reduces the
possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into
the system or undoing changes made by other users of software. The goals of a change control procedure
usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of
resources involved in implementing change.
Good Documentation Practices are the set of activities that enable you to record your raw data
and hand-written entries in a legible, traceable and reproducible manner. Compliance with FDA's GLP
regulations (21 CFR Part 58), as well as GMP regulations(21 CFR Part 211), requires the use of Good
Documentation Practices.
This seminar is intended to introduce and explain the concept of Good Documentation Practices, and provide
real-world examples of how to, and how not to, use GDPs.
Environmental Monitoring (E/M) is a program designed to demonstrate the control of viable
(living microorganisms) and non-viable particles in critical areas. These areas include clean-rooms for drug
fill/finish, formulation tank rooms, laminar flow hoods, biological safety hoods, isolators, glove boxes, molding
machines, kit assembly lines, Intravenous (IV) compounding areas and sterile packaging. The session will
discuss environmental monitoring from a viable particles perspective.
What is ISPE ?
We are an independent organization led by the world's top pharmaceutical manufacturing professionals. We provide an
inviting and neutral environment for experts, technologists, regulators, consultants and students to exchange ideas and
practical experience. As a vibrant community, ISPE’s Members work together to improve the industry, while helping each
other make more educated decisions, more quickly than ever before.
08:30 - 09:30
09:30 - 09:45
Breakfast & Registration
Mr R Raghunandanan,
Director, ISPE India Affiliate,
Mumbai
Introduction to ISPE
Sh.Navneet Marwaha
09:45 - 10:00
Drugs Controller Address State Drugs Controller,
10:00 - 10:45
Mr Kapil Bhargava,
Good Laboratory Practice Director, ISPE India Affiliate,
Mumbai
10:45 - 11:15
Himachal Pradesh
Schedule L1:
Tea/Cofee Break
11:15 - 12:00
Deviation Handling
Mr R Raghunandanan,
Director, ISPE India Affiliate,
Mumbai
12:00 - 12:45
Corrective &
Preventive Action
Mr R Raghunandanan,
Director, ISPE India Affiliate,
Mumbai
12:45 - 13:45
Lunch Break
Mr Vijay Kshirsagar,
Director, ISPE India Affiliate &
EVP, Corporate QA & RA,
Unichem Labs Ltd, Mumbai
13:45 - 14:30
Change Control
Process
14:30 - 15:15
Good Documentation
Practice
15:15 - 15:45
15:45 - 16:30
16:30 - 17:30
Dr Arvind Kumar Mishra,
President, Parabolic Drugs,
Chandigarh
Tea/Cofee Break
Environmental
Monitoring
Mr R Raghunandanan,
Director, ISPE India Affiliate,
Mumbai
Panel Discussion
REGISTRATION DETAILS
Fee: INR 1500/E-mail us at admin@ispeindia.org or write to Affiliate Manager, ISPE India,
1001 Dalamal House, 10th Floor
Nariman Point
Mumbai 400 021
T: +91 - 22 - 3008 9475
F: +91 - 22 - 2204 5309
E: admin@ispeindia.org
Registration form for program on
India
“Schedule L1 & QMS”
ISPE Affiliate
R
Venue: Best Western Royal Park Hotel
Baddi Nalagarh Road, Bhud
Dist. Solan, Baddi 174101, India
Ph: +91 1795 645555
Date: 26 February, 2011
ENGINEERING
PHARMACEUTICAL
INNOVATION
Registration Fees:
1500/4750/- (With 1 Year ISPE Membership)
Name (Dr./Mr./ Ms./ Mrs)
(In Block Letters)
(Surname)
(First)
(Middle)
Designation:
Organization:
Address of Correspondence:
(City)
Phone (Board)
(State)
(Pin)
Fax
Phone (Direct)
Email(Personal):
Mobile
Official:
Area of Interest:
I wish to be kept informed about ISPE events (Please Tick)
INR
Payment Details:
(Cheque/DD No.)
(Date)
(Amount)
(Payable in Mumbai)
Bank Details(Name & Address)
Payment must be made through Cheque / DD payable at Mumbai in favor of “ISPE INDIA AFFILIATE”
at the mailing address. The completed registration form is to be sent along with the payment
Send your applications to:
ISPE India Affiliate, 1001 Dalamal House, 10th Floor, Nariman Point, Mumbai 400 021
Before 22.02.2011 (Spot Registrations subject to availability)
Terms and Conditions:
1. Delegates may be substituted at any time
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, alterations or cancellations from your organization as a result of substitutions