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	Read the Session: Pharmaceutical Industry Overview and Responsibilities of quality functions   Part 1 Introduction and Definitions Part 2 Pharmaceutical Industry Overview Part 3 Responsibilities of quality functions Part 4 New FDA Strategic Action Plan and quality functions
Answer the question:	Why quality systems are necessary?

 

Session 2	Read the Session:  Setting up an organization for  DRUG DEVELOPMENT & manufacturing PROCESS  Part 1 Drug Research and Development Part 2 Pre-Clinical Studies of Drug / Product Candidates Part 3 Testing of Experimental Drugs in Humans Part 4 Pharmaceutical Manufacturing  Part 5 Setting up an organization
Answer the question:	Propose QA organization with minimum staff for start-up company. Explain why your proposal should be accepted.

 

Session 3	Read the Session: Day-to-day operations
Answer the question:	What are the main principles of setting daily standards?

 

Session 4	Read the Session: The quality function
Answer the question:	What is the difference between QC and QA?

 

Session 5	Read the Session: Conclusions: QA functions
Answer the question:	What are the main reasons for failure of quality efforts in new start-up companies' ? Explain why.

 

Session 6	Read the Session: Profile of a research & development (pre-GMP) Company
Answer the question:	What are main characteristics that most research and development (R&D) companies have in common?

 

Session 7	Read the Session: Profile of a production (GMP compliant) company
Answer the question:	What are the main differences in quality assurance functions between  start-up R&D and GMP compliant companies?

 

Session 8	Read the Session: How can a successful pre-GMP become a successful GMP compliant company (Sorry graphics disabled)
Answer the question:	What is corrective action plan?

Sample Documents

 

Session 9	Read the Session: Conclusions on GMP Compliance
Answer the question:	Why GMP regulations can be considered an excellent business outline?

 

Session 10	Read the Session: Purpose of QA documentation
Answer the question:	List fundamental purposes that QA documentation serves.

 

Session 11	Read the Session: Types and purposes of documents and documentation
Answer the question:	What SOP-s in QA are about?

Sample Documents Sample: Guidelines for Writing an SOP

 

Session 12	Read the Session: Good laboratory practice (GLP) documentation
Answer the question:	What are the requirements for laboratory documents  outlined in 21 CFR 211.194 ?
BIORESEARCH MONITORING - GOOD LABORATORY PRACTICE GLP
Sample Documents

 

Session 13	Read the Session: GMP documentation
International Conference on Harmonization Good Manufacturing Practice Guidance CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS

Answer the question:

What GMP documentation should include?

 

Session 14

Read the Session: GCP

ICH GCP Documents
Answer the question:	What are main principles of GCP?

 

Session 15	Read the Session: Overview of validation
Answer the question:	What  philosophy stands behind  Validation?

 

Session 16	Read the Session: General system and process validation
Answer the question:	Talk in your own words about validation of filtration.

 

Session 17	Read the Session: Validation of bulk drug manufacturing
Answer the question:	Why in biopharmaceutical production, it is often easier to achieve a specific level of product purity than it is to prove it?

 

Session 18	Read the Session:Validation of pharmaceutical manufacturing
Answer the question:	Talk about Aseptic Processing.

 

Session 19	Read the Session: General topics, Calibration
Answer the question:	What is Calibration?

 

Session 20	Read the Session: Materials qualification interactions
Answer the question:	What system is used for material selection and control  in most biotechnology organizations?

 

Session 21	Read the Session: Qualification of materials
Answer the question:	Why it is recommended that small biotechnology companies use most experienced suppliers?

 

Session 22	Read the Session: Point of use for materials
Answer the question:	What are two basic types of uses for materials?

 

Session 23	Read the Session: FDA
Answer the question:	What are five centers FDA is divided into, and what are their functions?

 

Session 24	Read the Session: Testing
Answer the question:	What specifications are required for raw materials?

 

Session 25	Read the Session:Documentation for release of materials
Answer the question:	What documentation is needed to operate the materials release system?

 

Session 26	Read the Session: General overview of analytical methodologies
Answer the question:	What are basic characteristics of protein products?

 

Session 27	Read the Session: Tests  Physical tests Identity tests Assays Potency tests Purity tests Conclusion
Answer the question:	Please, list basic characteristics of quality tests.

 

Session 28	Read the Session:  Variation and error definitions Estimating the standard deviation Cookbook comparison techniques
Answer the question:	Why terms "precision" and "accuracy" are  different   statistically?

 

Session 29	Read the Session:  Process capability—yield enhancement Documents
Answer the question:	What steps should be implemented for a yield enhancement study?

 

Session 30	Read the Session:  Sampling methods and applications
Answer the question:	What important things should one keep  in mind  applying sampling plans?

 

Session 31	Read the Session:  Validation of analytical methods Summary concepts in experimental design Statistical process control primer and reference tool
Answer the question:	What is SPC? Give appropriate explanations.

 

Session 32	Read the Session:  Safety and waste management Setting up the program The paper trail The regulatory jungle
Answer the question:	What is EHS? Give appropriate explanations.

 

Session 33	Read the Session:  Emergency response-evacuation planning Other required reports Key elements Emergency response teams-programs
Answer the question:	What do CPR techniques include?

 

Session 34	Read the Session:  Chemical handling and disposal Biological materials Where to find regulatory information
Answer the question:	What are general principles of chemical handling and disposal?

 

Session 35	Read the Session:  Regulatory affairs FDA Rulemaking and adjudication United States Pharmacopeia (USP) and National Formulary (NF) Product characterization Functions of regulatory affairs Conclusion Europe is not only EC Issues in the EC Issues in the EFTA
Answer the question:	Please, formulate definitions of "drug", "device", "biological product".

 

Session 36	Read the Session:  Canadian Pharmacopeia
Answer the question:	What is DPD and NOC?

 

Session 37	Read the Session:  MANUFACTURING PROJECT MANAGEMENT
Answer the question:	What are the main principles of manufacturing projects management?

  

Please make sure you have completed all the necessary requirements: (you have to submit the answers to  all open questions) before you begin. If this is a second attempt, make sure you have waited until the specified re-test date or your score will not be recorded. PROCEED TO FINAL QA EXAM

PROCEED TO QA PRACTICAL PROJECT

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