General Information

Here are brief summaries of some of the educational & training courses which Fox Quality is currently proud to offer. Whilst standard versions of these courses are available (and recommended) they can also be tailored to meet your specific requirements.

  • All of the courses are aimed at ‘bridging the gap’ between a traditional academic environment and industry, therefore providing participants with a competitive advantage, when applying or interviewing for positions, enabling them to ‘hit the ground running’ upon appointment.

  • Participants will gain a greater understanding of the roles and positions available across the pharmaceutical industry as well as be exposed to the diverse range of organisations operating within this sphere.

  • Whilst the courses have an overarching focus on the pharmaceutical development industry, many are also extremely relevant to any industry utilising quality systems e.g. food, healthcare, environment, transport, information technology, energy, and agriculture. People planning a career in these areas are strongly encouraged to participate.

For further details about any of our courses | including availability and costing | please contact simonlake@foxquality.com.au

COURSES

  • This course provides a perfect introduction to the quality system principles which provide the foundations for  GxP compliant studies / facilities.

    The following topics are explored through an engaging, contemporary program of activities:

    Risk Assessment | Control of Records | Auditing | Corrective & Preventive Action (CAPAs) | Quality System Documentation | Training Records | Equipment / Facility Records | Computerised System Validation | Archiving / Retention of Records | Business Continuity

    This course may be completed as either an intensive 2-day course (in-person or online) or as a module-based online course undertaken at your own pace.

    Pre-Course Requirements: None

    Min / Max Group Size (Intensive): 4-6 People

  • This course acts as an introduction to the OECD Principles of GLP.

    Topics explored, via an engaging and contemporary program of activities, include:

    A Brief History | Organisational Roles | Study Structure | Facility, Equipment & SOPs | Test Items |

    Test Systems | Study Plans | Study Conduct | Study Reports | Record Retention

    This course may be completed as an intensive 1-day course (in-person or online).

    Pre-Course Requirements: To maximise the value of this course, a ‘healthy understanding’ of general quality systems is recommended or completion of Course 1 (GxP Quality Systems - The Basic Principles).

    Min / Max Group Size (Intensive): 4-6 People

  • This course acts as an advanced review of the OECD Principles of GLP.

    Building on the topics explored in Course 2 (Conduct of a GLP Compliant Study - Basic) participants will undertake a range of activities including:

    Preparation of a Study Plan | Conduct of a Study (Participants will be required to respond to a series of real-time challenges that reflect the realities of conducting GLP compliant studies) | Preparation of a Study Report

    This course may be completed as an intensive 1-day course (in-person or online).

    Pre-Course Requirements: To maximise the value of this course, a ‘healthy understanding’ of the Principles of GLP is required or completion of Course 2 (Conduct of a GLP Compliant Study - Basic).

    Min / Max Group Size (Intensive): 4-6 People

  • This course acts as an introduction to ICH GCP.

    Topics explored, via an engaging and contemporary program of activities, include:

    A Brief History | Organisational Roles | Clinical Protocols | Ethics | Recruitment | Screening | The Pharmacy / Investigational Product | The Clinical Unit | The Laboratory | Clinical Trial Conduct

    This course may be completed as an intensive 1-day course (in-person or online).

    Pre-Course Requirements: To maximise the value of this course, a ‘healthy understanding’ of general quality systems is recommended or completion of Course 1 (GxP Quality Systems - The Basic Principles).

    Min / Max Group Size (Intensive): 4-6 People

  • This course acts as an advanced review of ICH GCP.

    Building on the topics explored in Course 4 (Conduct of a GCP Compliant Study - Basic) participants will undertake a range of activities including:

    Preparation of a Clinical Protocol | Conduct of a Clinical Trial (Participants will be required to respond to a series of real-time challenges that reflect the realities of conducting GCP compliant studies)

    This course may be completed as an intensive 1-day course (in-person or online).

    Pre-Course Requirements: To maximise the value of this course, a ‘healthy understanding’ of ICH GCP is required or completion of Course 4 (Conduct of a GCP Compliant Study - Basic).

    Min / Max Group Size (Intensive): 4-6 People

  • This course acts as an introduction to Bioanalytical Method Validation undertaken in accordance with FDA / EMA Guidelines. Both chromatographic and immunoassay methods will be reviewed.

    Topics explored, via an engaging and contemporary program of activities include:

    Basic Calculations | Analytical Reference Standards | Calibration Standards / The Calibration Curve | Quality Control Samples | Reporting | Critical Assessments:

    • Accuracy & Precision

    • Linearity

    • Sensitivity

    • Dilution Integrity

    • Stability (In-Matrix & Solution) - Multiple Assessments

    • Matrix Effects

    • Selectivity

    • Recovery

    • Concomitant Medication

    • Heamolysed QCs

    • Carryover

    • Batch Size

    This course may be completed as an intensive 1-day course (in-person or online).

    Pre-Course Requirements: To maximise the value of this course, a ‘healthy understanding’ of general quality systems is recommended or completion of Course 1 (GxP Quality Systems - The Basic Principles).

    Min / Max Group Size (Intensive): 4-6 People

  • This course acts as an advanced review of Bioanalytical Method Validation.

    Building on the topics explored in Course 4 (Conduct of a GCP Compliant Study - Basic) participants will undertake a range of activities including:

    Preparation of a Validation Protocol | Conduct of an Assay Validation (Participants will be required to respond to a series of real-time challenges that reflect the realities of conducting assay validations in accordance with FDA / EMA guidelines) | Preparation of a Validation Report

    This course may be completed as an intensive 1-day course (in-person or online).

    Pre-Course Requirements: To maximise the value of this course, a ‘healthy understanding’ of bioanalytical method validation is required or completion of Course 6 (Bioanalytical Method Validation - Basic).

    Min / Max Group Size (Intensive): 4-6 People

  • This course acts as an introduction to Bioanalytical Sample Analysis undertaken in accordance with FDA / EMA Guidelines (e.g. the analysis of pharmacokinetic / toxicokinetic samples). Both chromatographic and immunoassay analysis will be reviewed.

    Topics explored, via an engaging and contemporary program of activities include:

    System Suitability Test | Batch Analysis | Acceptance Criteria:

    • Standards

    • Quality Controls

    | Calibration Range | Internal Standard | Carryover | Sample Reinjection | Sample Reassay | Repeat Analysis Acceptance Criteria | Incurred Sample Re-Analysis | Reporting of Results

    This course may be completed as an intensive 1-day course (in-person or online).

    Pre-Course Requirements: To maximise the value of this course, a ‘healthy understanding’ of bioanalytical method validation is required or completion of Course 6 (Bioanalytical Method Validation - Basic).

    Min / Max Group Size (Intensive): 4-6 People

  • This course acts as an advanced review of Bioanalytical Sample Analysis.

    Building on the topics explored in Course 4 (Conduct of a GCP Compliant Study - Basic) participants will undertake a range of activities including:

    Preparation of a Sample Analysis Protocol | Conduct of Sample Analysis (Participants will be required to respond to a series of real-time challenges that reflect the realities of conducting sample analysis in accordance with FDA / EMA guidelines) | Preparation of a Sample Analysis Report

    This course may be completed as an intensive 1-day course (in-person or online).

    Pre-Course Requirements: To maximise the value of this course, a ‘healthy understanding’ of bioanalytical sample analysis is required or completion of Course 8 (Bioanalytical Sample Analysis - Basic).

    Min / Max Group Size (Intensive): 4-6 People

  • This course provides an overview of the practicalities and challenges associated with sample handling.

    Topics explored, via an engaging and contemporary program of activities, include:

    Sample Collection | Sample Labelling | Sample Transport | Sample Receipt | Sample Storage | Sample Stability | Sample Movement | Sample Disposal

    This course may be completed as an intensive 1-day course (in-person or online).

    Pre-Course Requirements: To maximise the value of this course, a ‘healthy understanding’ of general quality systems is recommended or completion of Course 1 (GxP Quality Systems - The Basic Principles).

    Min / Max Group Size (Intensive): 4-6 People