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Clinical Investigator Program + GCP Certificate + Full set of Clinical Site SOP's - CRI005

The Clinical investigation program offered by Clinwell coordinates scientists with complementary expertise who work together on defined research paths and share their data with one another.

The goal of the program is to train physicians in therapeutic areas in techniques and process utilized in patient-oriented research. The program prepares graduates to follow a career path as clinical scientists and possessing the technical skill and knowledge to solve the challenges faced on-the-job. It allows trainees to develop direct experience in the performance of clinical investigation and at the same time, through didactic course work, provides them with a strong foundation in the computational and statistical sciences, biomedical ethics, and principles of clinical pharmacology, in vitro and in vivo measurement techniques, and many aspects of the drug development process.

Students develop a strong foundation in patient-oriented research. Upon completion of the program, they are able to apply contemporary research tools to clinically relevant areas of investigation, and are competitive for careers in patient-oriented research in academic medicine, industry, and regulatory affairs.

Chapter 1	Introduction
Chapter 2	Definitions
Chapter3	Pharmaceutical Industry Overview
Chapter 4	Responsibilities of quality functions
Chapter 5	New FDA Strategic Action Plan and quality functions
Chapter 6	Drug Research and Development
Chapter 7	Pre-Clinical Studies of Drug / Product Candidates
Chapter 8	Testing of Experimental Drugs in Humans
Chapter 9	Pharmaceutical Manufacturing
Chapter 10	Setting up an organization for Drug Development & manufacturing Process
Chapter 11	Day-to-day operations
Chapter 12	Profile of a research & development (pre-GMP) Company
Chapter 13	How can a successful pre-GMP become a successful GMP compliant company
Chapter 14	Purpose of QA documentation
Chapter 15	Good laboratory practice (GLP) documentation/Bioresearch monitoring - Good laboratory practice
Chapter 16	GMP documentation/International Conference on Harmonization Good Manufacturing Practice Guidance
Chapter 17	ICH ICH GCP Documents
Chapter 18	Overview of validation
Chapter 19	General system and process validation
Chapter 20	Validation of bulk drug manufacturing
Chapter 21	Validation of pharmaceutical manufacturing
Chapter 22	General topics, Calibration
Chapter 23	Materials qualification interactions
Chapter 24	Point of use for materials
Chapter 25	Testing
Chapter 26	Documentation for release of materials
Chapter 27	Physical tests
Chapter 28	Assays
Chapter 29	Potency tests
Chapter 30	Variation and error definitions
Chapter 31	Process capability—yield enhancement
Chapter 32	Sampling methods and applications
Chapter 33	Validation of analytical methods
Chapter 34	Statistical process control primer and reference tool
Chapter 35	Safety and waste management
Chapter 36	Regulatory affairs
Chapter 37	Emergency response-evacuation planning
Chapter 38	Chemical handling and disposal
Chapter 39	Part 1 - Regulatory Affairs Part 2 - FDA Part 3 - Rulemaking and Adjudication Part 4 - United States Pharmacopeia (USP) and National Formulary (NF) Part 5 - Product characterization Part 6 - Functions of regulatory affairs Part 7 - Conclusion: Regulatory Affairs Part 8 - Europe is not only EC Part 9 - Issues in the EC Part 10 - Issues in the EFTA
Chapter 40	Canadian "Pharmacopeia"
Chapter 41	Manufacturing project management
Chapter 42	Introduction to six sigma
Chapter 43	HIPAA
Chapter 44	General principles of pharmacology
Chapter 45	Principles of pharmacodynamics, transduction and neurotransmission
Chapter 46	Kinetic principles of drug administration (Pharmacokinetic)
Chapter 47	Drug interactions and metabolism
Chapter 48	Drugs acting on the sympathetic nervous system (Adrenergic drugs)
Chapter 49	Antibiotics
Chapter 50	Drugs affecting the coagulation system
Chapter 51	Drugs used in treatment of allergies
Chapter 52	Treatment of central nervous system degenerative disorders
Chapter 53	Drugs for the treatment of viral diseases
Chapter 54	Chemotherapy of neoplastic diseases
Chapter 55	Drugs acting on the parasympathetic nervous system (Cholinergic drugs)
Chapter 56	Drugs used in dermatology
Chapter 57	Cardiac glycosides, antiarrhythics and drugs, used in ischemic heart disease
Chapter 58	Hormones, vitamins, and minerals
Chapter 59	Hypotensive drugs and lipids-lowering drugs
Chapter 60	OPIOID drugs
Chapter 61	NSAIDs - Nonsteroidal Antiinflammatory drugs