KRC Inc. QUALITY ASSURANCE AND REGULATORY AFFAIRS

ON-LINE PROGRAM

In order to complete this program you have to answer all open questions and pass on-line exam. Please  don't copy your answers from the text of the sessions. Formulate your answers in your own words.

Why do we ask open questions? Because we wish to prepare our students for job interview with prospective employer. Most of open questions are based on questions asked by employers on interviews with our previous graduates. That is why it is so important that you will answer each question as deep as you can. In order to make a good impression on prospective employer you should show a great deal of competence in professional terminology and concepts. So, please, use this opportunity to prepare yourself for real job interview by answering our open questions as best as you can.

  

SESSION 1	Introduction
SESSION 2	Definitions
SESSION 3	Pharmaceutical Industry Overview
SESSION 4	Responsibilities of quality functions
SESSION 5	New FDA Strategic Action Plan and quality functions
SESSION 6	Drug Research and Development
SESSION 7	Pre-Clinical Studies of Drug / Product Candidates
SESSION 8	Testing of Experimental Drugs in Humans
SESSION 9	Pharmaceutical Manufacturing
SESSION 10	Setting up an organization for  Drug Development & manufacturing Process
SESSION 11	Day-to-day operations
SESSION 12	Profile of a research & development (pre-GMP) Company
SESSION 13	How can a successful pre-GMP become a successful GMP compliant company
SESSION 14	Purpose of QA documentation
SESSION 15	Good laboratory practice (GLP) documentation/BIORESEARCH MONITORING - GOOD LABORATORY PRACTICE
SESSION 16	GMP documentation/International Conference on Harmonization Good Manufacturing Practice Guidance CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS
SESSION 17	ICH ICH GCP Documents
SESSION 18	Overview of validation
SESSION 19	General system and process validation
SESSION 20	Validation of bulk drug manufacturing
SESSION 21	Validation of pharmaceutical manufacturing
SESSION 22	General topics, Calibration
SESSION 23	Materials qualification interactions
SESSION 24	Point of use for materials
SESSION 25	Testing
SESSION 26	Documentation for release of materials
SESSION 27	Physical tests
SESSION 28	Assays
SESSION 29	Potency tests
SESSION 30	Variation and error definitions
SESSION 31	Process capability-yield enhancement
SESSION 32	Sampling methods and applications
SESSION 33	Validation of analytical methods
SESSION 34	Statistical process control primer and reference tool
SESSION 35	Safety and waste management
SESSION 36	regulatory affairs
SESSION 37	Emergency response-evacuation planning
SESSION 38	Chemical handling and disposal
SESSION 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
SESSION 40	Canadian "Pharmacopeia"
SESSION 41	MANUFACTURING PROJECT MANAGEMENT
SESSION 42	INTRODUCTION TO SIX SIGMA
SESSION 43	HIPAA
SESSION 44	GENERAL PRINCIPLES OF PHARMACOLOGY
SESSION 45	PRINCIPLES OF PHARMACODYNAMICS, TRANSDUCTION AND NEUROTRANSMISSION
SESSION 46	KINETIC PRINCIPLES OF DRUG ADMINISTRATION (Pharmacokinetic)
SESSION 47	DRUG INTERACTIONS AND METABOLISM
SESSION 48	DRUGS ACTING ON THE SYMPATHETIC NERVOUS SYSTEM (ADRENERGIC DRUGS)
SESSION 49	ANTIBIOTICS
SESSION 50	DRUGS AFFECTING THE COAGULATION SYSTEM
SESSION 51	DRUGS USED IN TREATMENT OF ALLERGIES
SESSION 52	TREATMENT OF CENTRAL NERVOUS SYSTEM DEGENERATIVE DISORDERS
SESSION  53	DRUGS FOR THE TREATMENT OF VIRAL DISEASES
SESSION 54	CHEMOTHERAPY OF NEOPLASTIC DISEASES
SESSION  55	DRUGS ACTING ON THE PARASYMPATHETIC NERVOUS SYSTEM (CHOLINERGIC DRUGS)
SESSION 56	Drugs Used in Dermatology
SESSION  57	CARDIAC GLYCOSIDES, ANTIARRHYTHICS AND DRUGS, USED IN ISCHEMIC HEART DISEASE
SESSION 58	HORMONES, VITAMINS, AND MINERALS.
SESSION 59	HYPOTENSIVE DRUGS AND LIPIDS-LOWERING DRUGS
SESSION 60	OPIOID DRUGS
SESSION 61	NSAIDs - NONSTEROIDAL ANTIINFLAMMATORY DRUGS
Practical Projects	Begin KRC QA Internship
Submit the Article	Submission of Industry Related Article to International Biopharmaceutical Association Publications and/or other Industry Publications
FINAL EXAM	http://training.krigertraining.net/qa/qa_enter.htm
Resume Help	Resume Help Session

 

INTERNATIONAL REGULATORY MODULE

 

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Copyright Kriger Research Center Inc. 2003