Code: SP6431

A recent industry survey highlighted that the #1 cause of loss of pharmaceutical productivity was the ineffective management of deviations. This workshop provides participants with current approaches to effective deviation management and the opportunity to work through practical examples.

Learning outcomes and benefits

On successful completion of this course, participants should be able to:

• Analyse and revise their company deviation management system for improvement
• Complete process deviations to minimise productivity losses
• Classify deviations based on risk to compliance and product integrity
• Structure deviation trend analyses
• Link significant deviations to the CAPA system

Suitability

The course is suitable for all supervisors and managers required to handle GMP-related deviations, for example:

• Release for Supply/Marketing Authorization Officers
• Compliance, Quality Assurance and Quality Control personnel
• Operations and related managers and supervisors

While the case studies are pharmaceutical related, the principles of deviation management equally apply to device and biotechnology manufacturers.

Participant's notes, case studies and certificates of successful completion will be provided.

Cost: $475 + GST

Download schedule here

Register

Code: SP6432

Regulators now expect that all companies have in place an effective quality management system (QMS). ICH Q10 provides the latest thinking on this area and ISO13485 provides an integrated model for implementing a QMS.

This workshop will enable participants to implement practical QMS elements such as CAPA, design control/transfer, and leverage customer feedback and audits.

Learning outcomes and benefits

On successful completion of this course, participants should be able to:

• Interpret and effectively apply ICH Q10 principles
• Assess and audit their internal or vendor QMS and the associated gaps to best practice
• Demonstrate “linkage” between related QMS elements, particularly CAPA systems
• Develop a highly efficient and integrated quality management system

Suitability

The course is suitable for all supervisors and managers required to work within or manage a QMS in devices, pharmaceuticals, and biologics, for example:

• Quality Assurance/Quality Control personnel and managers
• Compliance and quality systems auditors
• Operations Managers and Quality Engineers
• Vendor assurance personnel and managers
• Personnel responsible for implementing an integrated QMS

Participant's notes, case studies and certificates of successful completion will be provided.

Cost: $475 + GST

Download schedule here

Register

Code: SP6433

The life sciences industry invests significant resources in qualification and validation compliance. How much of this is real value added? Have you ever questioned whether there is a more effective and efficient approach? This workshop provides an alternative to the historical V Model for qualification and validation using a lean, risk-based approach, based on ASTM E2500 principles.

Learning outcomes and benefits

On successful completion of this course, participants should be able to:

• State the differences between the traditional V model and the ASTM E2500 approach.
• Separate commission and qualification activities
• Apply a risk based model to qualification
• Analyse company programs to identify lean validation opportunities

The participants will be asked to practice some Lean Validation approaches on industry case studies.

Suitability

The course is suitable for all supervisors and managers who work within, or are responsible for qualification, commissioning and validation in the pharmaceuticals, devices and biologics industries. In particular, these include:

• Quality Assurance/Quality Control personnel and managers
• Engineering personnel and managers
• Operations managers and Quality Engineers
• Validation personnel and managers

Participant's notes, case studies and certificates of successful completion will be provided.

Cost: $475 + GST

Download schedule here

Register

Code: SP6434

Failure investigation and root cause analysis are expected under cGMPs and the medical device QMS standards. Two of the most challenging issues facing the life sciences industry in a regulated environment are how to conduct efficient failure investigations and how to permanently implement corrective and preventive action.

This course introduces participants to systematic root cause analysis and the application of 6 Sigma tools and techniques.

Learning outcomes and benefits

On successful completion of this course, participants should be able to:

• Apply a systematic approach to problem solving and root cause analysis
• Utilise 6 Sigma tools such as cause and effect diagrams, ranking, matrix analysis, brainstorming, pareto analysis and some SPC tools.
• Apply risk analysis to quality and compliance problems

The participants will be able to practice 6 Sigma tools using industry case studies.

Suitability

The course is applicable at all levels within the life sciences industry. In particular, personnel from these areas would benefit most:

• Operations and manufacturing supervisors and managers
• Compliance, QA/QC personnel, supervisors and managers
• Quality and process improvement engineers
• Continuous improvement personnel and those interested in qualifying as 6 Sigma Black Belts

Participant's notes, case studies and certificates of successful completion will be provided.

Cost: $475 + GST

Download schedule here

Register

Code: SP6435

Leveraging your investment in effective training is a smart business principle. Ensuring your staff are skilled and competent in the workplace is also a fundamental requirement in the highly regulated life sciences industry.

While understanding the GMP “rules” is important, the key is changing the actual behaviour and practices of personnel engaged in GMP-related activities.

In this course, you will be introduced to new leading edge techniques that will engage personnel to think, act and change GMP-related behaviour in a compliance environment.

Note: The course is facilitated by Brian Szukala, our UK-based expert on Behavioral GMPs™.

Learning Outcomes and Benefits

On successful completion of this course, participants should be able to:

• Understand what Behavioral GMP™ means and how to implement it
• Leverage the effectiveness of learning and development initiatives using Behavioral GMP™ techniques and programs
• Implement real change in GMP-related culture and thinking within their company.

Suitability

If you are in a position to make change to the GxP culture of your organisation, then this course will be of significant benefit. The course is particularly applicable to Production Managers, Quality/Technical Managers, HR/Training and L&D Managers, and other operations personnel responsible for improving GMP-related behaviour in the life sciences industry. 

Participant's notes, case studies and certificates of successful completion will be provided.

Cost: $475 + GST

Download schedule here

Register