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Uday Shetty
Works at Drug Regulations
Attended University department of Chemical Technology
Lives in Mumbai


Uday Shetty

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Presentation on New WHO Guidance on Validation
WHO has recently issued draft
document titled "Guidelines on Validation".   These guidelines (i.e., the main text included
in this working document) cover the general principles of validation and
qualification. These guidelines focus mainly on
the overall c...
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Uday Shetty

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FDA Issues Technical Reference Document for Quality Metrics
FDA released a technical
reference document provides recommendations on the submission of data to
support quality metrics as part of the process validation lifecycle and
pharmaceutical quality system (PQS) assessment. The guide will provide clear
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Uday Shetty

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Presentation on New WHO Guidance on Computer System Validation
Computerized systems should be validated at the level appropriate for their intended use and in accordance with quality risk management principles. This applies to systems used in all good (anything) practices (GXP) activities (e.g. good clinical practice (...
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Uday Shetty

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US FDA Issues New Guidance on Elemental Impurities.
US FDA has issued a draft
guidance, which provides recommendations regarding the control of elemental
impurities of human drug products marketed in the United States consistent with
implementation of International Council for Harmonization (ICH) guidance fo...
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Uday Shetty

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The Generic Drug Approval Process
Original Article : CDER Conversations : US FDA  Generic drugs are copies of innovator or brand-name prescription drugs and make up about 88 percent of prescriptions filled in the United States. Brand-name drugs must demonstrate their safety and effectivenes...
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Uday's Collections
Quality Management
  • Drug Regulations
    Founder, 2010 - present
  • Janssen Pharmaceutica
    Site Head & VP, 1990 - 2010
Map of the places this user has livedMap of the places this user has livedMap of the places this user has lived
Mumbai - Mumbai
Providing Free Online Resources for the Pharmaceutical Professional.
Dr. Shetty is a  Pharmaceutical Management Professional with extensive experience in quality management, product development, technology transfers, commercial product support. His specialized expertise includes  contract manufacturing and process validations.  He has Supervisory experience in support functions like EHS, engineering and purchase.He is Quick and innovative thinker with ability to adapt rapidly to dynamic situations and is a consummate team player. 

In the immediate past he was the  Director at Contract Research Organization which he co-founded. Before that he was in leading Pharmaceutical companies like Janssen,GSK and Wyeth.He supervised large teams of Quality assurance, Quality Control and Product development. As a site head with Janssen he also supervised  general management functions like Finance, Purchase, Imports, engineering, EHS and Project Management. Dr. Shetty has set up, nurtured and grew number of organizations to deliver superior business results in the field of Quality management , Contract Research and Manufacturing. His specialties include Quality Management and Product Development. 
  • University department of Chemical Technology
    Pharmaceutical Technology, 1976 - 1984
Basic Information
Uday Shetty's +1's are the things they like, agree with, or want to recommend.
“No company will live or die because of high price premiums for drugs bu...

Reuters recently reported that Swiss drugmaker Roche plans to offer two blockbuster cancer drugs to the Indian consumers at significantly re

FDA issues a new SOP dealing with cargo thefts.

Warehouse thefts like Lilly's in 2010 are on the rise. Cargo theft mainly occurs during transportation as thieves make off with unattend

New PIC/S Recommendation for Risk-Based Inspection Planning in the GMP E...

This PIC/S Recommendation sets out a simple and flexible Quality Risk Management tool that may be used by Inspectorates when planning the fr

EMA's International Collaboration on Good Manufacturing Practice Inspect...

The European Medicines Agency has expanded the scope of the International Collaboration on Good Manufacturing Practice Inspection. The overa

FDA issues final rule for control & use of cut lables.

Due to significant problems with label mix ups and consequent recalls, FDA in 1987 and in 1990 reviewed the labeling procedures. The review

New FDA Draft Guidance on Appropriate Size Range for Beads Administered ...

Certain drug products that contain beads within a capsule indicate in the labeling that the capsule can be broken and the internal beads can

Should India Modify the Compulsory Licensing Provision of the Patent Law?

On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license

New FDA and EU regulations for packing of medicines.

Falsified medicines or counterfeits are a big problem in many parts of the world and has significant implications for patient safety. It als

New EU recommendations for laboratories that perform analysis of clinica...

Analysis and evaluation of samples collected from subjects participating in clinical trials forms a key part of the clinical trials process.

Is continuing manufacturing when acceptable smoke test results are await...

A scrutiny of the 483's and warning letters issued by the FDA in the last year or so indicate increasing vigilance of FDA on aseptic pro

Does WEST have monopoly over Moral and Ethical standards?

Chris Hansen of "Dateline" journeyed to India to expose CROs for indulging in unethical practices... Using publicly available info

New FDA guidance on Stability Evaluation

FDA has issued new draft guidance for Veterinary Medicine (CVM) which aims to implement the ICH requirements for Registration of Veterinary

Should Novartis withdraw the Patent Law challenge in India for Increment...

Ahead of the hearing of patent litigation for its anti-cancer drug Glivec in Supreme Court later this month, Novartis has said the outcome o

New FDA draft guidance on the use of Phthalates as Excipients.

Phthalate esters are synthetic chemicals with a broad spectrum of uses. Phthalates are found in certain pharmaceutical formulations, primari

Authorized Generics

Competition from authorized generics during the 180-day marketing exclusivity period has led to lower retail and wholesale drug prices. Spec

ICH S10 Guideline reaches Step 2 of the ICH Process

The purpose of this document is to recommend international standards for photosafety assessment, and to harmonise such assessments supportin

From Tylenol to Tylenol - A Missed Opportunity

Once upon a time many Johnsonian's and Ex-Johnsonian's were admirers of the J and J credo in light of the extraordinary positive les

Are Quality Professionals caught between the Devil and the Deep Sea ?

During last year Quality professionals have seen two large companies; Ranbaxy and Johnson and Johnson enter into a consent decree with the U