GUIDANCE ON FDA REGULATORY REQUIREMENTS FOR INDIAN PHARMACEUTICAL INDUSTRY - Seminar By GlobalCOmpliancePanel

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FDA India Seminar 2011 at Mumbai
GUIDANCE ON FDA REGULATORY REQUIREMENTS FOR
INDIAN PHARMACEUTICAL INDUSTRY
Overview
Dr. Kuwahara’s presentation will benefit all kinds of pharma
Dr.Steven S Kuwahara
companies, right from small molecule drug companies to
Founder & Principal, GXP Biotechnology
biologics companies and API and generics manufacturers
Steven S. Kuwahara, Ph.D. is the founder

and Principal of GXP BioTechnology
It will be very useful for Managers, Directors, Regulatory
LLC, a consulting firm that works in the
Associates and Analysts. The seminar will offer important
areas covered by the GLP and GMP of
learning to Quality and Regulatory and Research and
drugs, biologics, and nutraceuticals.
Development groups Heads.
Steve has over 30 years of experience in supervising quality

control laboratories, including an animal testing facility, and
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in performing GLP and GMP audits of internal and external
testing laboratories . Steve has participated in the

development of drugs and biologicals through all phases of
Date and Venue
clinical research and final product production.

more...
May 9th, 10th and 11th, 2011
Banquet hall (Majestic), Intercontinental

The LaLit,

Sahar Airport Road, Andheri East,
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Mumbai – 400059 INDIA
 
Contact number: 022 66992222
Seminar Content:
Conference timings: 9:00 am - 6:00 pm
Day 1 - 9th May 2011
Day 2 - 10th May 2011
Day 3 - 11th May 2011
Session 1: Introduction to U.S. Drug
Session 5: Violations and
Session 9: Out-Of-Specification
Regulation (90 min)
Responses (90 min)
(OOS) Test Results (90 min)
l
History of drugs and drug regulation
l
Inspections
l
Definitions and history of the OOS
up to the Food, Drug, and Cosmetic
l
Observations and 483’s
problem
Act(FDCA).
l
Warning Letters
l
Key amendments to the Food,
l
Beyond the Warning Letters
l
Including Out-of-Trend
Drugand Cosmetic Act.
l
Responding to the U.S. FDA
l
Definitions of Drugs, Biologics and
l
Current FDA Guidance
Devices.
Session 6: Filings & Submissions –
DMF and Clinical Trials (90 min)
Session 2: Laws and Regulations in
l
Responsibilities of the
l
Drug Master Files (DMF)
the U.S.(90 min)
laboratory
l
Clinical Trial (Research) Permits
l
FDCA to the regulations.
l
The full investigation
l
Application of risk analysis
l
Early Phase (Pre-clinical)
l
Need for CAPA
l
The U.S. Good Laboratory
l
Phase 1
l
OOS Investigation Protocol and
Practices (GLP)
l
Phase 1a
Report
l
The U.S. Good Manufacturing
l
Phase 1b
Practices (GMP)
l
Phase 2
¡ Including the Quality
Session 10: Risk Analysis and
l
Phase 2a
System Regulations for
Corrective and Preventive Actions
l
Phase 2b
Devices
(CAPA) (90 min)
l
Phase 3
l
Pharmacopeias
l
Pivotal Trials
l
Basic methods
l
Points-to-ConsiderG
l
Special Clinical Studies
l
Guidance Documents
l
Brain Storming, Brain Writing
l
The International Conference
 
l
Applications under the Animal Rule.
l
Fish Bone Diagrams and
on Harmonization (ICH)
related techniques.
l
World Guidance and World
GMP
l
Risk assessment and Scoring
Session 7: Filings & Submissions –
l
Fault Tree Analysis (FTA)
Session 3: The U.S. Drug GMP Part 1
NDA and BLA (90 minutes)
l
Applications to CAPA
(90 min)
l
The New Drug Application (NDA)
Session 11: Validations (90 min)
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Key definitions.
l
Basic requirements of the GMP-Part
l
Cleaning Validations
l
The Abbreviated New Drug
1
l
Sanitization and Sterility Validations
Application (ANDA)
l
Organization and Personnel
l
Environmental Monitoring and
l
Special Drug Applications
Validations
l
Buildings and Facilities
l
Equipment
l
Facility Commissioning
l
Control of Components.
l
The Biologics License Application
l
Analytical Method Validation
(BLA)
l
The ICH Common Technical
Session 12: Process Validation
Session 4: The U.S. Drug GMP –
Document(CTD)
(90 min)
Part 2 (90 min)
Session 8: Inspections and Audits
l
Combining the other validations
l
Basic requirements of the GMP –
(90 min)
l
The FDA Guidance Document on
Part 2.
l
The Quality System Inspection
Process Validation
l
Packaging and Labeling Controls
l
Inspections by Regulatory Bodies
l
Maintaining the process in a
l
Holding and Distribution
l
Preparation for Inspections and
validated state
l
Laboratory Controls
Audits
l
Records and Reports
l
Managing an inspection or audit
l
Returned Goods and Salvaging
l
Responding and follow-up to 483s
 

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Pricing List
Contact Information:
Ask for Suraj or Shwetha
Coordinators - India Seminar
Register By
Price INR
Savings
Phone number: +91 80-2642-1482 /
Between Mar 7th and Apr 9th
16,000
2,000
+91 80-3201-4957 / +91 80-3221-
3341.
Between Apr 11th and May 8th
18,000
0
Email:
customersupport@globalcompliancepanel.com We will be able to accommodate limited number of attendees so if you and your
GlobalCompliancePanel
 
colleagues would like to attend this training seminar, call us today at +91 80-
C/O Nichepro Consulting Pvt Ltd
2642-1482 / +91 80-3201-4957 / +91 80-3221-3341 to reserve your seat.
4th Floor, A, Block, Brigade Software
Park, Banashankari 2nd stage,
Bangalore-560070. INDIA
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Best regards,
Team
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