Professional Development Presenter Profiles

A range of providers have been engaged to develop and deliver training on behalf of MTAA.  Below are biographies of each presenter.

Presenter:   Ruth Berghan
Organisation:  Victorian Hospitals Industrial Association (VHIA)
Event:   3.3 Interpreting Medical Terminology

Ruth has extensive business experience at executive support level in a wide range of sectors including the corporate, legal, finance and health sectors and has experience as a Director within the small business sector. 

Ruth’s experience in the health sector includes working in the Sub-Acute and Allied Health Unit, Corporate Services Unit and the Legal Office of a major Melbourne metropolitan Health Service.

Ruth holds a Graduate Certificate in Business and Certificate IV Training & Assessment.

Presenter:   Margaret Butler (Sydney)
Organisation:  State-based Nurse Educator on behalf of Alison Evans Consulting
Modules:  3.5 Introduction to Operating Theatre Protocols
              3.6 Operating Theatre Protocols Update

Margaret Butler is a registered nurse whose qualifications include Perioperative Certificate, Bachelor of Nursing and Master Adult Education. 

Margaret is a Perioperative Nurse Educator in the Operating Suite of St Vincent's Hospital, Sydney.  In this role she coordinates several perioperative nursing education programs including the Perioperative Nursing Clinical Program, which includes students from St Vincent's Hospital and St Vincent's Private Hospital operating suites. 

Margaret is also an Honorary Clinical Fellow of the Australian Catholic University School of Nursing (NSW & ACT) and is the Coordinator of Perioperative & Anaesthetic and Recovery Room Specialty Practice Units for the ACU National Master of Health Science - Clinical Practice.

Presenter:   Paula Canniffe
Organisation:  Victorian Hospitals Industrial Association (VHIA)
Module:  5.15 Motivating Others at Work
              
Paula is an experienced trainer/mentor/coach who has worked in management and development roles for over 20 years.  She has designed and delivered management development programs across a range of industries, including clients in the health sector.  Having been a practitioner in management/staff development programs, providing guidance and support to managers and teams, Paula is skilled in delivering workshops that focus on interpersonal skills such as mentoring, coaching, staff counselling, conflict resolution and mediation.

Paula also facilitates a Leadership Program for Leadership Management Australia, focussing on the development of effective leadership and management skills.  She manages a program called Bizness Babes which is sponsored by the Wise Foundation and supported by The Body Shop. 

Paula’s qualifications include a Graduate Diploma of Business (Organisation Dynamics) from Swinburne University of Technology; Bachelor of Social Sciences (Hons) from University College, Dublin and Certificate IV in Workplace Training.  Paula is also an accredited Myers-Briggs Type facilitator.

Presenter:   Richard Corboy
Organisation:  Victorian Hospitals Industrial Association (VHIA)
Module:  5.7 Performance Management

Richard Corboy has worked in the Health Industry since 1976, holding senior management positions with HR, IR, training and development and OHS responsibilities at various health services. Immediately prior to joining VHIA, Richard worked for VECCI as a Senior IR Consultant.

Richard's field of expertise includes human resource management, training, industrial relations, occupational health and safety and workers compensation.

Richard's qualifications include studies in Graduate Certificate in Human Resource Management and a Certificate IV in Assessment and Workplace Training.

Presenter:   Natasha Cushway
Organisation:  Victorian Hospitals Industrial Association (VHIA)
Module:  3.3 Interpreting Medical Terminology

Natasha holds dual qualifications in nursing and law.  She is currently employed as an Employment/IR Consultant at VHIA specialising in nursing issues, employment and industrial law and the disability sector.  Natasha is a Registered Nurse Division 1.

Natasha's background includes specialisations in acute surgical nursing in the areas of urology and gynaecology. She maintains currency in her nursing practice.

Presenter: Stefan Czyniewski
Provider: Mobius Medical
Event:  1.8 Introduction to the Regulation and Design of Clinical Investigations for Medical Technology in Australia 
1.9 Improving Your Clinical Investigations for Medical Technology

Graduating with a bachelor degree in Medical Science from the University of Sydney in 2000, Stefan worked as a research assistant for an orthopaedic surgeon, primarily on hip and knee resurfacing prosthesis and autologous chondrocyte implanting in post market research.

In 2003, Stefan joined the clinical research team at Fornier Pharma (now Solvay Pharmaceuticals) and was based at the Clinical Trial Centre at the NHMRC. Stefan worked as a clinical research associate and data manager on the FIELD study, a multi-centre, international, phase III study. His role at the clinical trials centre included project management for Australian and New Zealand clinical sites, coordinator of a cardiovascular sub-study and assisting with laboratory data processing.

In 2006, Stefan moved back into the device space working as a Senior Clinical Research Associate at Ventracor. Stefan was placed in charge of the clinical dossier for CE Marking of the VentrAssist, which was achieved in December 2006. In 2007 Stefan was promoted to Clinical Affairs Manager at Ventracor and continued this posting until 2009.

Stefan is a founding member of Mobius Medical and is the company’s Clinical Affairs Director. Stefan brings with him a sound knowledge and experience of clinical trial management and regulatory report submission requirements required for device approval. His experience includes clinical trial design, database design, project management and regulatory reporting requirements.

  

 

 

 

 

 

 

 

 

 

 

Presenter:   Sue Driscoll
Organisation:  Health Communications
Module:  5.17 Media Skills

Sue is the Chief Executive Officer of Health Communications, an associate of Victorian Hospitals Industrial Association. Health Communications specialises in providing public relations and marketing support to the Australian health care sector. Her clients include all areas of healthcare: metropolitan and rural hospitals, aged care and disability agencies, mental health support, community health, health partnerships, general practice organisations and disease-specific support groups.

Sue is an experienced practitioner who worked in major metropolitan Melbourne hospitals and Victorian health agencies for around 20 years. During this time she coordinated hospital and network responses to major crises including infection outbreaks, industrial action, coronial inquests, funding shortfalls, facility and equipment malfunctions and the many media stories – good and bad news – that face a Victorian public hospital. She has taught strategic communication planning and community relations to Masters students, as well as writing and editing courses at undergraduate and postgraduate levels. In addition she has provided industry training for health and PR managers on communication planning, issues and crisis management – and of course media management. An ex-journalist, she is a former President of the Public Relations Institute of Australia (Victoria), organised the Institute’s last two overseas study tours (to the US and UK) and has been a regular commentator on public relations and communications on ABC Radio.

Presenter: Dr Martin Devitt
Provider: Mobius Medical
Event:  1.8 Introduction to the Regulation and Design of Clinical Investigations for Medical Technology in Australia 
1.9 Improving Your Clinical Investigations for Medical Technology

Martin graduated with a Bachelor of Medicine from the University of Newcastle (Australia) in 1997. He initially became a registrar in anaesthetics and intensive care, but in 2000 joined the Therapeutic Goods Administration (TGA), a statutory body of the Australian Government that regulates the supply of therapeutic goods (medical devices, medicines, etc.) in Australia. As Head of the Clinical Section in the Office of Devices, Blood and Tissues, his role included the provision of high level advice on clinical considerations in the regulation of medical devices; participation on the TGA’s Medical Devices Expert Committee (MDEC) and Medical Device Incident Review Committee (MDIRC); the development of legislation and policy initiatives both nationally and internationally, including input into the workings of the Global Harmonisation Task Force (GHTF); participation as a member on a committee of Standards Australia; and the auditing of quality management systems to ISO 13485.

In 2005, he joined Cook Australia to undertake the position of Medical Director in a global capacity, providing high-level clinical advice on pre- and post-market safety, quality, performance, and marketing issues pertaining to the manufacture and supply of medical devices globally.

Martin is a founding member of Mobius Medical and is the company’s Medical Director. He brings medical devices experience from both the regulator and the industry. His expertise encompasses clinical and regulatory input into all aspects of medical device research and development, manufacturing, and commercialisation, including clinical trials, clinical evidence, and post-marketing issues; health technology assessment of medical devices for reimbursement; and quality management system auditing to ISO 13485 and clinical trial auditing to ICH GCP.

Martin has successfully completed the Company Directors Course (CDC) through the Australian Institute of Company Directors (AICD) and is a Director on a number of Boards. He is able to provide corporate advisory services to companies pursuing the commercialisation of medical devices.  Martin also practices emergency medicine part-time.

 

Presenter:  Professor Stewart Dunn
Organisation:  University of Sydney
Module:  3.8 Communicating Effectively with Healthcare Professionals

Stewart Dunn is Professor of Medical Psychology at the Sydney Medical School, based at Royal North Shore Hospital, and Visiting Medical Psychologist at the Mater Hospital, North Sydney.  He has extensive teaching commitments in the USyd Medical Program and has published widely on doctor-patient communication, and psychological predictors of morbidity and mortality in medical illness.  His clinical specialty is the psychological care of cancer patients and their families.  He is Director of the Pam McLean Centre, which develops evidence-based simulations of difficult cancer communication situations for health professionals, using professional actors.

Presenter:   Alan Edgecomb
Organisation:  Alan Edgecomb Consulting
Module: 1.3 Quality Management Systems and Conformity Assessment Procedures

Alan Edgecomb has more than 30 years experience in the medical device industry.  Alan has worked as a service engineer for Siemens Medical Systems and Philips Medical in South Africa and for General Electric Medical Systems in Australia.

Alan was the Quality and Regulatory Affairs Manager for the South East Asia region of General Electric Medical Systems and most recently the Quality and Service Manager for an Australian start-up company, ImpediMed Limited. 

Alan has been involved with ISO 9001 and ISO 13485 quality management systems for the last 13 years having implemented and managed QMS at various sites in Australia.  Alan has been running QMS training courses for the past 7 years.

Presenter:   Helen Kierce
Organisation:  Victorian Hospitals Industrial Association (VHIA)
Modules:   Orientation to Leadership & Management E-learning Series

Helen Kierce manages the Training Services Unit at the Victorian Hospitals Industrial Association (VHIA).  She has over 13 years experience as a manager, consultant and trainer in the field of professional, personal and workplace based training.  Helen’s current role involves leading the development the VHIA’s training program, including overseeing the strategic direction and expansion of the training business to meet the needs of the members of the Association.  She manages a small team of full-time staff supplemented by a broad range of associate trainers and training partners. 

Helen graduated with a Bachelor of Economics Degree from Monash University in 1983 and has since completed a Graduate Diploma of Business (Organisational Behaviour), a Master of Professional Education; and Training and a Certificate IV Training and Assessment.  Helen’s focus is on devising relevant, responsive and engaging professional development programs that enable employees and managers to reach their full potential at work.

Presenter:   Michelle Loth (Brisbane)
Organisation:  State-based Nurse Educator on behalf of Alison Evans Consulting
Modules:  3.5 Introduction to Operating Theatre Protocols
              3.6 Operating Theatre Protocols Update

Michelle Loth has worked as a registered nurse in operating theatres for over 10 years.  Her qualifications include Bachelor of Nursing, Graduate Certificate in Nursing (Perioperative) and Certificate IV in Workplace Training & Assessment.

Michelle has worked at the Royal Brisbane & Women's, Holy Spirit Northside and The Prince Charles Hospitals.  She has experience in elective and emergency surgery, particularly focusing in the speciality areas of urology, vascular and burns.  She has worked in a variety of roles including registered nurse, clinical nurse, clinical pathways project manager and nurse educator.  Currently, she is the Perioperative and Procedural Areas Nurse Educator at The Prince Charles Hospital, Chermside.  Her role includes the education of staff within the operating theatre, recovery, sterilising department and endoscopy unit as well as corporate education for all hospital staff. 

Presenter:    Merv Neal
Organisation:  Victorian Hospitals Industrial Association (VHIA)
Modules:  5.8 Managing Work Priorities & Delegation
              5.9 Achieving a Work/Life Balance
              5.12 Engaging Presentations

Merv Neal has owned and operated his own businesses for more than 30 years and is presently the CEO of Laughteryoga International.  He is an Associate Fellow of the Australian Institute of Management and an Affiliate Member of the National Speakers Association, where he received the Mentor of the Year for 2004, and Speaker of the Year nominee for 2006.

Merv now spends his time as a professional speaker, trainer and facilitator in the areas of Strategic Business Planning, Leadership, Culture and Stress Management.

Presenter:  Patricia Nicholson (Melbourne)
Organisation:  State-based Nurse Educator on behalf of Alison Evans Consulting
Modules:  3.5 Introduction to Operating Theatre Protocols
              3.6 Operating Theatre Protocols Update

Patricia Nicholson comes with a wealth of experience in nursing education. Patricia teaches adult acute care (majoring in perioperative and anesthetic nursing), as well as general nursing and midwifery at the University of Melbourne's School of Nursing and Social Work, where she holds the position of Coordinator of Postgraduate Specialty Programs. 

Patricia is an Executive member of the Victorian Perioperative Nurses Group and is the Victorian Director for the Australian College of Operating Room Nurses including current Chair for the ACORN 2010 – 2011 Standards.  Patricia is currently on a leave of absence from the University in order to complete her PhD.

Presenter:   Cliff Spong
Organisation:  Medical Technology Association of Australia (MTAA)
Modules:  1.1 Introduction to the Regulation of Medical Technology in Australia
              1.2 Advanced Review of the Regulation of Medical Technology in Australia
              1.3 Quality Management Systems and Conformity Assessment Procedures
              1.5 Understanding Clinical Evidence for Medical Technology

Cliff joined MTAA in late 2005 and is now the Director of Regulatory and Scientific Affairs.

Cliff has a Bachelor of Engineering and Master of Biomedical Engineering degrees from the University of New South Wales.  He is a Fellow of the Institution of Engineers Australia. Following his Masters degree, Cliff established the first rehabilitation engineering department in a public hospital in eastern Australia at Royal South Sydney Hospital in conjunction with the University of New South Wales.  During this time he also lectured in post graduate biomechanics at the University.

After working for Telectronics as Head of the Biomechanical Research Group; and Telstra, in the areas of occupational health and safety and risk management, Cliff moved to the Therapeutic Goods Administration where he spent 12 years in various senior positions in the medical devices regulatory program.

Presenter:  David Strangward
Organisation: Victorian Hospitals Industrial Association (VHIA)
Modules: 5.3 Management and Leadership Essentials
             5.4 Managing to Minimise Risk 
             5.5 Leading to Influence
             5.6 Team Development
             5.13 Negotiation: A framework for successful communication
             5.14 Managing Conflict in the Workplace
             5.16 Managing Time Effectively

David Strangward has consulted to many of Australia's largest organisations in banking, insurance, mining, training, telecommunications in a variety of roles from project management, large IT systems implementation, customer relationship management and training.

David has extensive and varied business, IT and training experience.  He is a CEO and Managing Director of two organisations and in these roles utilises his extensive leadership and management skills whilst focusing on:
• strategy development and implementation;
• business strategy development; and
• staff development and training.

His leadership skills, team focus and integrity continue to earn him the respect of his colleagues and clients.

Presenter:   David Wenban
Organisation:  Victorian Hospitals Industrial Association (VHIA)
Modules:   3.3 Professional Conduct
              3.4 Hospital Protocols

David Wenban is Principal Legal Consultant for the Victorian Hospitals Industrial Association; Director, Health Financial Pty Ltd; and Director VHIA Health Communications.

David brings a wealth of health sector experience to his current roles.  With his unique combination of knowledge and qualifications in executive management, legal and clinical aspects of the industry David is well placed to train and advise on Professional Conduct and Hospital Protocols.

David's previous postings include: Corporate Counsel, Western Health; and Chief Executive Officer, Cobram District Hospital. 

Presenter:  Louise White
Organisation:  SeerPharma
Module:  1.10 Biohazards and Sterilisation

Louise White has over 20 years experience in the Biotech and the Pharmaceutical industry in sterile manufacturing, Quality Assurance and Consulting.  Louise has provided QA oversight over a variety of validation projects as well as preparing validation documentation associated with many capital works projects.  She has conducted GMP compliance audits and gap analysis for international companies.  Louise has developed many GMP training courses including self-paced computer-based training.

Louise's areas of expertise include GxP training program development and delivery, FDA/TGA and EU cGMP compliance and gap analysis, quality management systems and validation across devices, pharmaceuticals and biologics.


Presenter:  Steve Williams
Organisation:  SeerPharma
Modules:  1.4 Developing Technical Documentation for Medical Technology
              1.6 Risk Analysis and the Development of Medical Technology
              1.7 Risk Management for Medical Technology Companies from a Regulatory Perspective

Steve Williams has over 35 years experience in the Life Sciences industry in Quality Assurance, Manufacturing and Consulting.  He has conducted numerous FDA and TGA/PICs compliance audits and gap analysis for many international companies as well as developed multiple training courses for GMP, GLP, Validation, Risk Management, HACCP and Medical Devices.  He regularly presents at conferences and industry seminars on a range of subjects relating to QA, Risk Management and GMP compliance.  Steve also specialises in e-Learning compliance training solutions for intranet delivery within the Life Sciences industry.

Steve has consulted in QA, GMP, GLP and Validation since 1989 and has prepared many companies for regulatory inspections.  Steve is also a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA) and in this role, conducts GMP licensing audits on behalf of the Australian government.

Steve's areas of expertise include Risk Assessment, FDA/TGA and EU cGMP Compliance & Gap Analysis, Quality Assurance, Quality Management Systems (QMS) and Medical Device QMS, e-Learning/training specialist, Validation, Sterile Products, Good Laboratory Practices (GLPs), Hazard Analysis and Critical Control Point (HACCP) and GMP, GLP and validation training.

 

Presenter: Suzanne M. Williams (BSc Hons)
Provider: Mobius Medical
Event:  1.8 Introduction to the Regulation and Design of Clinical Investigations for Medical Technology in Australia 
1.9 Improving Your Clinical Investigations for Medical Technology

Suzanne studied Applied Biological Science at Manchester University in the UK graduating in 1993. Suzanne joined ICON Clinical Research (UK), as a Clinical Research Associate, enjoying exposure to many therapeutic areas within the pharmaceutical clinical trials arena. Following a year sabbatical in their Chicago office, and armed with a sound understanding of FDA as well as European regulations, Suzanne moved to Australia to help establish ICON’s new Sydney office in 1997. She went on to gain extensive experience of ‘big pharma’ clinical trials management at Searle, Pharmacia and Pfizer.

In 2003, Suzanne set up a consulting business independently contracting for several overseas companies, solely in the arena of medical device clinical trial management. Managing the local sites for a number of diverse studies, Suzanne gained expertise in medical device clinical trials in a diverse range of therapeutic areas including cardiovascular, gynaecology, and reproductive medicine. In 2006, Suzanne joined the clinical team at Ventracor, assisting with the successful completion of the pivotal trials that enabled the company to obtain the CE Mark of the device.

Suzanne is one of the founding members of Mobius Medical Pty Ltd and her role focuses on liaising with clients and the clinical investigational staff to develop, initiate, resource and project-manage a wide variety of medical device clinical trials. Armed with her thorough understanding of theoretical and practical aspects of GCP, Suzanne also offers advice and conducts training programs for clinical research personnel.