Raaj gprac courses

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Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com

Raaj GPRAC India’s 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 & StudentsEligibility: 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

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We have our expertise in following courses: Category I: 6m Advanced PG Diploma in Drug Regulatory

Affairs (Formulations) Category II: 6m Advanced PG Diploma in Drug Regulatory

Affairs (API) Category III: 4m Certification course in CTD and eCTD in

Formulation Category IV: 4m Certification course in CTD and eCTD in API Category V: 4m Certification course in Quality Assurance &

Quality Management Category VI: 4m Certification course in Clinical Research Category VII: 3m Certification course in Pharmaceutical

Documentation Category VIII: 3m Certification Course in Pharmacovigilance Category IX: 6m Advanced PG Diploma in Patents Laws and

Procedures Category X: 3m Patent Agent Exam Preparation Course Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com

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What you will learn under each category of course?


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Category I: 6m Advanced PG Diploma in Drug Regulatory Affairs (Formulations)


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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


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Category II: 6m Advanced PG Diploma in Drug Regulatory Affairs (API)


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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


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Category III/IV: 4m Certification course in CTD and eCTD in Formulation / API


eCTD

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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 Copyright: Raaj GPRAC, Mumbai 2012-2013 www.rajgprac.com

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Category V: 4m Certification course in Quality Assurance & Quality Management


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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


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Category VI: 4m Certification course in Clinical Research


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Category VI: 4m Certification course in Clinical Research

Salient Features : Clinical Research profession, its role & importance General Overview of the Pharmaceutical Industry, CRO’s its functioning,

role of various functions like Clinical Research associate, Clinical Team Leader, Project Manager, Manager-Clinical Trial Supplies, QA Manager, Data Manager, Medical & Regulatory Affairs Manager, Biostaticians, Data Entry Operator, Head of Clinical Operations, etc

Drug Development Process including Clinical trials Animal studies in drug development, Regulatory process in preclinical

studies GCP as per ICH E6 Fundamentals of Monitoring Clinical Trials Project management along with Risk Management Clinical Safety & Pharmacovigilance-AE, ADR, SAE, UADR, etc With additional information on Clinical Data Management


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Category VII: 3m Certification course in Pharmaceutical Documentation


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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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Category VIII: 3m Certification Course in Pharmacovigilance


DRUG SAFETY

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Category VIII: 3m Certification Course in Pharmacovigilance

Salient Features : Introduction & Objectives of Pharmacovigilance ADR –Classification & types, PMS ICH Guidelines with respect to Quality & safety Pharmacovigilance Methods Wings & Role of Pharmacovigilance Scope of Pharmacovigilance Signal Detection & Analysis Good PV Practices Periodic Safety Updates (PSUR)


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Category IX: 6m Advanced PG Diploma in Patents Laws and Procedures


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Category IX: 6m Advanced PG Diploma in Patents Laws and Procedures

Salient Features : Overview of the Pharmaceutical Industry and Importance

of IPR & Patents International Treaties/ Conventions on IPR Patents Laws and Procedures for Indian patents USPTO, Title 35 CFR European Patent regime Business Model Patents- Biotech Patents Software Patents Patentability of Life Forms Many Case Studies on Patent Laws


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Raaj gprac courses