Personal Information
Organization / Workplace
Hyderabad Area, India, Telangana India
Occupation
Assistant General Manager (AGM) - Quality Assurance at Aurobindo Pharma
Industry
Medical / Health Care / Pharmaceuticals
About
Good knowledge about current regulatory requirements and extensive experience in performing internal audits and ensuring the compliance.
Working experience for review and audit submission documents along with supporting data related to R&D, Production, Quality control and Regulatory Affairs.
Good working experience in handling OOS, OOT, Incidents and CAPA related to analysis.
Extensive experience in Analysis and Review of raw materials, finished products and stability samples.
Good working knowledge of software like Empower, Tiamo, SDMS, LIMS, QMS, DMS, TRIMS, LDRO etc.
Experience in Performing and Monitoring GMP activities.
Extensive experience in preparation of schedules, ...
Tags
pharmaceutical
warning letters
483s
news
new guidelines
guidance
fda warning letter
483's
non compliance reports
audit findings
gmp
regulatory
newsletter
fda
regulations
news uptoday new guidance new mapp release audit
analytical
eu non compliance reports
updates
data integrity
hplc
error
laboratory
buildings and facilities
21 cfr 211.42
ema non compliance reports
who noc
21 cfr 211.165
pharmaceutical news
21 cfr 211.100; gmp;
new
21 cfr 211.67
chromatography data system (cds) in pharma
investigations
batch record review
21 cfr 211.192
detecting and preventing issues
21 cfr 211.22
21 cfr 211.160
december 2014
quality control
glp
summary
october 2014
pharma septemer 2014 news
483
uk guest of the month dr. m damodharan - vice pre
bulgaria - scm pharma limited
india - vetprom ad
solid dosage processing
all about tablets (pharma)
tablet manufacturing process
introduction
processing problems
unit operations
excipients
oos
investigating aberrant potency values in pharma an
aberrant
investigation
- introduction - roles & responsibilities- reaso
sample preparation techniques of solid dosage form
hplc or gc chromatography - apextrack integration
regulations of july 2014
audit observations
pharma
noc
regulation of the month pharma june 2014
news uptoday new guidelines audit findings guest o
findings
guidelines audit
pharmaceutical industry
waters
chromatography
See more
Presentations
(17)Documents
(21)Likes
(3)New Draft FDA Guidance on Analytical Method Development & Validations.
GMP EDUCATION : Not for Profit Organization
•
8 years ago
Monthly Magazine - Pharma Uptoday Volume 9, Issue Dec 2014
Sathish Vemula
•
9 years ago
cGMP's for sterile products
GMP EDUCATION : Not for Profit Organization
•
10 years ago
Personal Information
Organization / Workplace
Hyderabad Area, India, Telangana India
Occupation
Assistant General Manager (AGM) - Quality Assurance at Aurobindo Pharma
Industry
Medical / Health Care / Pharmaceuticals
About
Good knowledge about current regulatory requirements and extensive experience in performing internal audits and ensuring the compliance.
Working experience for review and audit submission documents along with supporting data related to R&D, Production, Quality control and Regulatory Affairs.
Good working experience in handling OOS, OOT, Incidents and CAPA related to analysis.
Extensive experience in Analysis and Review of raw materials, finished products and stability samples.
Good working knowledge of software like Empower, Tiamo, SDMS, LIMS, QMS, DMS, TRIMS, LDRO etc.
Experience in Performing and Monitoring GMP activities.
Extensive experience in preparation of schedules, ...
Tags
pharmaceutical
warning letters
483s
news
new guidelines
guidance
fda warning letter
483's
non compliance reports
audit findings
gmp
regulatory
newsletter
fda
regulations
news uptoday new guidance new mapp release audit
analytical
eu non compliance reports
updates
data integrity
hplc
error
laboratory
buildings and facilities
21 cfr 211.42
ema non compliance reports
who noc
21 cfr 211.165
pharmaceutical news
21 cfr 211.100; gmp;
new
21 cfr 211.67
chromatography data system (cds) in pharma
investigations
batch record review
21 cfr 211.192
detecting and preventing issues
21 cfr 211.22
21 cfr 211.160
december 2014
quality control
glp
summary
october 2014
pharma septemer 2014 news
483
uk guest of the month dr. m damodharan - vice pre
bulgaria - scm pharma limited
india - vetprom ad
solid dosage processing
all about tablets (pharma)
tablet manufacturing process
introduction
processing problems
unit operations
excipients
oos
investigating aberrant potency values in pharma an
aberrant
investigation
- introduction - roles & responsibilities- reaso
sample preparation techniques of solid dosage form
hplc or gc chromatography - apextrack integration
regulations of july 2014
audit observations
pharma
noc
regulation of the month pharma june 2014
news uptoday new guidelines audit findings guest o
findings
guidelines audit
pharmaceutical industry
waters
chromatography
See more