Pharmaceutical courses and training institute, Thane presentation

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Title: Pharmaceutical courses and training institute, Thane

1

Raaj GPRAC Indias Best Training Institute,
Offers Advanced PG Diplomas through Various Fast
Track training and Distance Learning programmes
in
Regulatory Affairs
CTD/eCTD
Quality Assurance/Quality Management
Pharma Documentation
Clinical Research
Pharmacovigilance
Patent Laws Procedures
Patent Agent Exam Preparation
For Pharma/Biotech/Life Sciences working
Professionals Students
Eligibility Freshers like B.Pharm/M.Pharm/
PhD/B.Tech/M.Tech/ B.Sc/ M.Sc/Biotech/ BAMS/BHMS
/BDS/MDS/MBBS/MD and RA, QA, Clinical
Professionals

Category I 6m Advanced PG Diploma in
Drug Regulatory Affairs (Formulations)
Salient Features
Understanding Regulatory Affairs profession, its
role importance
General Overview of the Pharmaceutical Industry,
its functioning, role of various departments
Overview of Worldwide Regulatory Agencies
Drug Development Process with Clinical Phases I,
II, III IV
Drug Registration in Regulated Markets like
USFDA, EUROPE, Canada etc
Drug Registration with Rest of the World (RoW)
like ASEAN Countries, Latin America, Middle East
Countries, etc
Understanding of QbD and ICH topics from Q1, Q2,
Q3 to Q11, cGMP, GLP, GCP, etc
PDR (Product Development Report) and Writing as
per ICH Q8
Details of CTD modules I, II, III, IV V and
Understanding core concept of eCTD.
Electronic Submissions 21 CFR Part 11 NeeS,
eCTD, ESG, etc

Category II 6m Advanced PG Diploma in
Drug Regulatory Affairs (API)
Salient Features
Understanding Regulatory Affairs profession, its
role importance
General Overview of the Pharmaceutical Industry,
its functioning, role of various departments
API Characterization Impurities
Drug Substance Registration in Regulated Markets
like USFDA, EUROPE, etc
Drug Substance Registration with Rest of the
World (RoW)
CTD Format for DMF
Certificate Of Suitability (CoS), etc
Electronic Submissions 21 CFR Part 11 NeeS,
eCTD, ESG, etc

eCTD
Copyright Raaj GPRAC, Mumbai 2012-2013
www.rajgprac.com
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Category III/IV 4m Certification course in
CTD and eCTD in Formulation / API
Salient Features
Understanding Regulatory Affairs profession, its
role importance
General Overview of the Pharmaceutical Industry,
its functioning, role of various departments
Overview of ICH guidelines
Organization of CTD
Overview of eCTD
eCTD Submission for USFDA
eCTD Submission for European Union Filings
Differences between US Europe eCTD Submissions
Electronic Submissions 21 CFR Part 11 NeeS,
eCTD with xml backbone, etc

Category V 4m Certification course in
Quality Assurance Quality Management
Salient Features
Understanding Quality Assurance/ Quality Control
profession, its role importance
General Overview of the Pharmaceutical Industry,
its functioning, role of various departments
Overview of GLP, GMP
Introduction of ICH Emphasis on ICH Q7
Validations like Process, Water system,
Cleaning, HVAC, Sterile Procedures, Computer
Systems, etc
GMP-Schedule M of D C Act, WHO requirements,
USFDA guidelines, Documentation requirements
QA Aspects on Complaints, Recalls, Change
Control, Deviation Control, Vendor Approvals,
Recovery, Annual Product review, etc
Audit Preparations- GMP Compliance to
International Regulatory Standards such as WHO,
USFDA, EDQM, MHRA, FDA, etc
Vendor Auditing
Effective SOP Writing in a GMP environment, Good
Documentation Practices, etc

Category VII 3m Certification course in
Pharmaceutical Documentation
Salient Features
Understanding Pharma Documentation profession,
Quality Management system (QMS)
SOPs, Protocols, Master Formula plan,
Manufacturing Records, Packing Records, Batch
Records, BMR, Specifications, Warehousing,
Sampling, etc
Training Qualifications of Personnel
Validation Documentation
Documentation Control
Product Development Documentation
Specification of Drug Product
Stability testing Documentation

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