All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.

SOUTH AFRICAN QUALIFICATIONS AUTHORITY

REGISTERED QUALIFICATION THAT HAS PASSED THE END DATE:

Postgraduate Certificate: Total Quality Management: Pharmaceuticals

SAQA QUAL ID	QUALIFICATION TITLE
17102	Postgraduate Certificate: Total Quality Management: Pharmaceuticals
ORIGINATOR
Health Science Academy (Pty) Ltd
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY			NQF SUB-FRAMEWORK
-			HEQSF - Higher Education Qualifications Sub-framework
QUALIFICATION TYPE	FIELD		SUBFIELD
National Certificate	Field 03 - Business, Commerce and Management Studies		Generic Management
ABET BAND	MINIMUM CREDITS	PRE-2009 NQF LEVEL	NQF LEVEL	QUAL CLASS
Undefined	120	Level 7	Level TBA: Pre-2009 was L7	Regular-Provider-ELOAC
REGISTRATION STATUS		SAQA DECISION NUMBER	REGISTRATION START DATE	REGISTRATION END DATE
Passed the End Date - Status was "Registered"		SAQA 1536/01	2003-07-01	2006-06-30
LAST DATE FOR ENROLMENT		LAST DATE FOR ACHIEVEMENT
2007-06-30		2010-06-30

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.

This qualification does not replace any other qualification and is not replaced by any other qualification.

PURPOSE AND RATIONALE OF THE QUALIFICATION

Provide qualifying learners with the skills to enable them to be considered eligible for employment at a management level in the pharmaceutical industry, having shown competence in knowledge and application in the fields of Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practices and Medicine Registration (Good Regulatory Practice)

LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING

1. Learners who register for this qualification will already have a B Pharm degree or other similar tertiary qualification or qualifications in the medical or pharmaceutical industry 2. This qualification recognises, through the submission of portfolio of evidence, the formal/non-formal/informal prior learning which learners who register for the programme leading to the award of the qualification bring to the learning situation More advanced courses such as Managing Clinical Trials, Clinical Trial Regulatory update, Total Quality Management. GMP & GLP training can be progressed from this qualification as well The GCP course will assist an applicant in securing a position in the Pharmaceutical Industry and particularly clinical research. With this qualification an inexperienced person will be able to pursue the following positions; clinical trial assistant, clinical research associate, clinical trial co-ordinator, etc. Recognition of prior learning: This qualification may be achieved in whole or in part through the recognition of prior learning

RECOGNISE PREVIOUS LEARNING?

Y

EXIT LEVEL OUTCOMES

a). Critical cross-field outcomes: Identify and solve problems in which responses display that responsible decisions, using critical and creative thinking, have been made Work effectively with others as a member of the team or group Organise and manage one self and one`s activities responsibly and effectively Collect, analyse, organise and critically evaluate information Communicate effectively, using visual, mathematical and/or language skills, either orally or written Use science and technology effectively and critically showing responsibility towards the environment and the health of others Demonstrate understanding of the world as a set of related systems Contribute to the full personal development of each learner and the social and economic development of the society at large b). Specific outcomes: Part 1. Good Clinical Practice: 1. Understand the process of new drug development, from product discovery and development through the classic phases of research 2. Understand and be able to explain the importance of GCP in today`s current environment, through thorough knowledge of the origin, history & development of GCP. The learner will also be able to relate to the need for GCP, its legal status & implementation 3. Have knowledge of and be able to adhere to the principles of the ICH Guidelines for clinical research, both in terms of the conduct and reporting of clinical studies 4. Interpret and evaluate a clinical trial protocol, in accordance with the requirements of ICH GCP. Distinguish between the different types of trial design and clinical research methodologies 5. Interpret a Case Report Form and assess both the practical and theoretical aspects of this document, as well as its relevance to the protocol 6. Identify the purpose, contents & management of the Investigator`s Brochure 7. Understand the important component of Ethics in Clinical Research, specifically with regard to GCP and be able to apply the ethical principles of the Declaration of Helsinki to the constitution & composition of Ethics Committees, and the Informed Consent process in a practical situation 8. Monitor a study according to ICH GCP, as a result of having acquired working knowledge of the purposes, phases and functions of the monitoring process 9. Clearly identify the Essential Documents for the conduct of a clinical trial that are required both in the study master file & the investigator study file 10. Identify the categories of adverse drug reactions, and define the types of adverse report. Report the adverse drug reactions in events. Report the adverse drug reactions in accordance with the local regulatory authority requirements and the requirements of ICH GCP. 11. Prepare investigational sites for an audit, and understand the purpose and process of auditing a clinical trial. Develop an awareness of common audit findings 12. Fully understand the responsibilities of the Investigator and the Sponsor in the conduct of a clinical trial 13. Identify which regulatory documents are required/need to be complete throughout the conduct of a clinical trial, e.g. application to conduct a clinical trial, clinical trial progress reports, FDA 1572, etc. 14. Close out a clinical trial upon termination of a study, in accordance with ICH GCP 15. Plan for a new clinical trial, incorporating the principles of GCP in every step of the process Part 2. Good Laboratory Practice: 1. Describe the differences between various Good Laboratory Practices in different parts of the world 2. Detail how Quality Assurance is developed 3. Validate a test method 4. Draw up a Standard Operating Procedure 5. Demonstrate and explain how a study plan is developed 6. Have knowledge and understanding of the ISO 9001 Quality Management system 7. Detail how quality systems auditing is carried out Part 3. Good Manufacturing Practice: 1. History and evolution of modern quality practices: Identify the historical sources of modern quality practices and techniques Interpret the importance of national ethos on quality practices Identify the techno-paradigm shifts as exemplified in the Japanese role model List and describe the explicit tools used in modern quality practices Interpret the various sections and inputs to a QFD chart Identify and differentiate between the many names, definitions and aliases for modern-day practices Identify the importance of a customer-orientated focus in quality control Describe the genealogical lines of influence of modern-day practices 2. Statistical Process Control: Interpret the concept of statistical significance and be able to apply it to statistical inference and hypothesis testing Distinguish between continuous and discrete data distributions Describe the significance of the central limit theory Explain the significance of sample size to hypothesis testing Explain the importance of normality in statistical inference testing Apply statistical inference in pharmaceutical production process control Apply statistical hypothesis testing production process control Describe the requirements set by international GMP guides for SPC 3. Sampling theory: Describe and apply sampling theory and acceptance sampling techniques Describe how to determine alpha and beta-error probabilities Describe the advantages and disadvantages of acceptance sampling Interpret the theory and techniques of fixed and sequential sampling plans Test acceptance-sampling techniques to reduce process variability Recognise the sampling requirements of international GMP guidelines Design sampling plans for attributes and variables using MIL STD 105-D and 105-E 4. Quality control charts for attributes and variables: Name the various control charts for attributes and discuss their selection criteria Name the modifications that can be made when sample sizes are unequal Name the attribute control charts that can be used when one wishes to detect small process shifts Name the various control charts for variables and discuss their selection criteria Discuss the statistical basis for the use of "Runs" test in detecting trends in processes Distinguish between conformance to "engineering" specification and a process that is statistically "under control" Describe what steps to be taken when a process is out of control and discuss the rationale of this approach List the formulae for process capability analyses, and in particular describe the formulae for potential capability analysis and its significance to process control 5. Experimental design: Discuss the quadratic loss function and the Taguchi definition of cost of quality Recognise the concept of process "noise" Identify various "signal-to-noise" ratio figure-of-merit metrics Choose and select criteria for robust design techniques to solve quality problems in pharmaceutical production processes and also to improve product design 6. International GMP standards: Recognise the glossary of terms used in US CGMP guidelines Recognise selected key sections of US 21 CFR 210 and 211, the proposed changes to these sections and interpret and apply these guidelines to real-life problem solution Discover the rationale behind proposed changes to key sections Recognise the glossary of terms used in Canadian CGMP guidelines Recognise selected key sections of the Therapeutic Products Program, proposed changes to Canadian CGMP guidelines made via this program and interpret and apply these guidelines to real-life problem solution Discover the rationale behind proposed changes to key sections Discover the history of ISO Recognise various ISO Standards Recognise the roles of ISO Standards and their use and adaptation to GMP practices 7. Validation of systems and processes Apply and interpret SPC techniques in process validation Identify the various control charts for attributes and their selection criteria Demonstrate the capability to design an attribute control experiment using control charts Identify the various control charts for variables and their selection criteria Demonstrate the capability to design a variable control experiment using control charts Demonstrate the correct use of hypothesis testing to verify that process quality has improved Explain the use of process capability indices Part 4. Good Regulatory Practice: Be familiar with the provisions of the legislation governing medicine registration in South Africa Understand the structure and administration of the Medicines Regulatory Authority Know and be able to apply the procedures required for submitting medicine registration applications Know how to compile a medicine registration application for human, veterinary, biological or homoeopathic medicine Know how to manage the medicine registration process Know the provisions for the control of pharmaceutical advertising Update and maintain medicine regulatory licences Understand the role of the regulatory affairs department in the support of sales and marketing functions of the company

ASSOCIATED ASSESSMENT CRITERIA

a). Critical cross-field assessment: Solve problems by means of exploring and critically evaluating abstract and personal situations Solve problems by generating alternative strategies for dealing with those problems Demonstrate organisation and management skills and effective communication with others Collect, analyse organise and critically evaluate information Show the use of science and technology effectively and critically b). Specific assessments: Part 1. Demonstrate understanding of new drug development, from product discovery and development through the classic phases of research Be able to explain the importance of GCP, its legal status & implementation Be able to demonstrate knowledge of and adhere to the principles of the ICH Guidelines for clinical research both in terms of the conduct and reporting of clinical studies Peer evaluation of a mock protocol completed in a group workshop setting Completion of a mock Case Report Form, showing content and practical application of the document, including monitoring skills Demonstrate ability to identify the purpose, contents 7 management of the Investigator`s Brochure Evaluate a mock informed consent form to show the learner`s knowledge of the required composition of an informed consent document Evaluate a mock monitoring report form to demonstrate the learner`s interpretation of the document by obtaining feedback on the performance of the investigator & CRA in the case study Identify which essential documents belong in which file for the conduct of a clinical trial by applying knowledge from precious lectures in the course Identify and define the type of adverse event in different cases, and specify the reporting procedures for each event Demonstrate understanding of the purpose & process of an audit, and of the need for accurate & reliable data Show the importance of informed consent, monitoring, adverse events, etc. Demonstrate use of the relevant regulatory documents, and of referral to these documents in a workplace situation, including specifically when submitting documents to the Regulatory Authorities Compile a checklist of issues that need to be addressed when closing out a clinical trial Show how to plan a clinical trial in the workplace Part 2. Develop a Quality Assurance Programme for Good Laboratory Practice Describe how the programme developed, would validate a particular test Develop a Study Plan for a specific instance Describe the sections of ISO 9002 and how they can be used and applied in the laboratory situation Carry out a Quality System Audit Part 3. Identify the historical sources of modern quality practices and techniques Interpret the importance of national ethos on quality practices Identify the techno-paradigm shifts as exemplified in the Japanese role model List and describe the explicit tools used in modern quality practices Interpret the various sections and inputs to a QFD chart Identify and differentiate between the many names, definitions and aliases for modern-day practices Identify the importance of a customer-orientated focus in quality control Describe the genealogical lines of influence of modern-day practices Interpret the concept of statistical significance and be able to apply it to statistical inference and hypothesis testing Distinguish between continuous and discrete data distributions Describe the significance of the central limit theory Explain the significance of sample size to hypothesis testing Explain the importance of normality in statistical inference testing Apply statistical inference in pharmaceutical production process control Apply statistical hypothesis testing production process control Describe the requirements set by international GMP guides for SPC Describe and apply sampling theory and acceptance sampling techniques Describe how to determine alpha and beta-error probabilities Describe the advantages and disadvantages of acceptance sampling Interpret the theory and techniques of fixed and sequential sampling plans Test acceptance-sampling techniques to reduce process variability Recognise the sampling requirements of international GMP guidelines Design sampling plans for attributes and variables using MIL STD 105-D and 105-E Name the various control charts for attributes and discuss their selection criteria Name the modifications that can be made when sample sizes are unequal Name the attribute control charts that can be used when one wishes to detect small process shifts Name the various control charts for variables and discuss their selection criteria Discuss the statistical basis for the use of "Runs" test in detecting trends in processes Distinguish between conformance to "engineering" specification and a process that is statistically "under control" Describe what steps to be taken when a process is out of control and discuss the rationale of this approach List the formulae for process capability analyses, and in particular describe the formulae for potential capability analysis and its significance to process control Discuss the quadratic loss function and the Taguchi definition of cost of quality Recognise the concept of process "noise" Identify various "signal-to-noise" ratio figure-of-merit metrics Choose and select criteria for robust design techniques to solve quality problems in pharmaceutical production processes and also to improve product design Recognise the glossary of terms used in US CGMP guidelines Recognise selected key sections of US 21 CFR 210 and 211, the proposed changes to these sections and interpret and apply these guidelines to real-life problem solution Discover the rationale behind proposed changes to key sections Recognise the glossary of terms used in Canadian CGMP guidelines Recognise selected key sections of the Therapeutic Products Program, proposed changes to Canadian CGMP guidelines made via this program and interpret and apply these guidelines to real-life problem solution Discover the rationale behind proposed changes to key sections Discover the history of ISO Recognise various ISO Standards Recognise the roles of ISO Standards and their use and adaptation to GMP practices Apply and interpret SPC techniques in process validation Identify the various control charts for attributes and their selection criteria Demonstrate the capability to design an attribute control experiment using control charts Identify the various control charts for variables and their selection criteria Demonstrate the capability to design a variable control experiment using control charts Demonstrate the correct use of hypothesis testing to verify that process quality has improved Explain the use of process capability indices Part 4. Knowledge and application of the previsions of the legislation governing medicine registration in South Africa Demonstration of understanding of the structure and administration of the Medicines Regulatory Authority Demonstration of the procedures required for submitting medicine registration applications Showing how to compile a medicine registration application for human, veterinary, biological or homoeopathic medicine Showing how to manage the medicine registration process Application of the provisions for the control of pharmaceutical advertising to specific situations Update and maintain medicine regulatory licences Explanation and demonstration of the role of the regulatory affairs department in the support of sales and marketing functions of the company Integrated assessment: Assessment in the programme is based on integrated and continuing assessment with due consideration of the following principles: Learning is best achieved when the learner is able to see the relevance of the concept Learning is improved through reflective practice where the learner is given the opportunity to apply concepts and reflect on what has been learnt Learning is enhanced if the learner is provided with the opportunity for regular assessment, which informs his/her learning Small group discussion is an important feature of learning since it enables the learner to express doubts and build up confidence in a non-threatening environment Learners acquire insight into the assessment criteria which are considered important when asked to undertake their own assessment and the assessment of peers Assessment takes place through the assessment of the relevant unit standards and through assignments, with emphasis on continuous assessment during the learning programme Assessment entails 3 elements: Formal end of course assessment Continuing formal assessment Continuing informal assessment Formative and summative: Formative and summative assessment are integrated The following quality assurance procedures form part of the overall evaluation and accredited system: Internal assessors, examiners and moderators External assessors, examiners and moderators Accreditation requirements and guidelines of the South African Pharmacy Council Requirements and guidelines of the further education and training quality assurance bodies (SAQA requirements) An internal review as part of Health Science Academy`s quality assurance systems

ARTICULATION OPTIONS

More advanced short courses following on from this qualification include: Managing Clinical Trials, Clinical Trial Regulatory Update, Medicine Registration Update, all presented by Health Science Academy The GCP section of the certificate would assist a learner in securing a position in the Pharmaceutical Industry, and particularly clinical research. With this qualification an inexperienced person will be able to pursue the following positions, clinical trial assistant, clinical research associate, clinical trial co-ordinator, etc.

MODERATION OPTIONS

A system of internal and external moderators will be used. These will be drawn from suitably qualified staff members of the Health Science Academy and from Potchefstroom University for CHE. Where professional or statutory bodies are involved in determining the curriculum, they will also be involved in moderation

CRITERIA FOR THE REGISTRATION OF ASSESSORS

Our own staff will be used as assessors in a manner accommodated within the quality management system of our training institution. This would apply as well to outside assessors who may be contracted for their specific expertise in certain fields

LEARNING PROGRAMMES RECORDED AGAINST THIS QUALIFICATION:

NONE

PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS QUALIFICATION:

This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.

NONE

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All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.