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