Events
GMP Training Course in Hong Kong
| DAY | DATE | COURSE | FACILITATOR |
|---|---|---|---|
| Day 1 | 28 Nov: | Sion Wyn |
|
| Day 2 / 3 | 29 / 30 Nov: | Multi-product manufacturing facility design and cross contamination to PIC/S standards |
Gordon Farquharson |
| Day 4 | 01 Dec: | Quality Systems, Quality Policy, Quality Manual, CAPA, Deviations and OOS |
Ann Choong, Trevor Schoerie & John Montalto |
| Day 5 | 02 Dec: | Marc Fini, Trevor Schoerie & John Montalto |
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Day 1: Computer Systems Validation Training - Booking Closed
Date: |
28 November 2011 - Booking Closed |
|---|---|
Location: |
The Cityview Hotel, 5F Diamond Room. |
Address: |
23 Waterloo Road, Kowloon, Hong Kong |
Function Time: |
0900-1700hrs |
Pricing: |
HK $2000 |
Learn from world expert Sion Wyn
In order to provide our clients with the latest in risk-based computer systems validation advice, PharmOut is committed to providing on-going training and development of our staff and clients.
We are offering an introductory training course on using a risk-based approach to validating computer systems, with training by Sion Wyn who is a world leader in the topic.
This is a unique opportunity to hear the latest from someone who works closely with the regulators and a chance to discuss any particular computer systems validation questions that you may have with Sion.
About the trainer
Sion Wyn is widely recognised as a world leader and expert in computer systems validation.
Sion is the editor of the ISPE’s GAMP 5 Guide – A Risk-Based Approach to Compliant GxP Computerized Systems and is a member of the ISPE GAMP Council, GAMP editorial board and the GAMP Europe Steering Committee.
He worked with the FDA on the revised 21CFR Part 11 and is a member of the team that produced the FDA Guidance on 21CFR Part 11 Scope and Application. He received the FDA Group Recognition Award for his work on Part 11 and is the technical expert on the FDA’s ORA Virtual University on-line training modules on computerised systems validation and maintenance.
Sion also runs his own consultancy, Conformity IT, providing computer validation and compliance services to the pharmaceutical and other healthcare industries.
Day 2 & 3 - Multi-product manufacturing facility design and cross contamination to PIC/S standards. - Booking Closed
Date: |
29-30 November 2011 (Two day event) - Booking Closed |
|---|---|
Location: |
The Cityview Hotel, 5F Diamond Room. |
Address: |
23 Waterloo Road, Kowloon, Hong Kong |
Function Time: |
0900-1700hrs |
Pricing: |
HK $4000 |
This course provides an overview of the concepts utilized in the development of sound designs for multi-product facilities that manufacture pharmaceutical oral solid dosage form products in today's regulatory environment. The workshop course will include a review of facility design, operations, and regulatory issues in the PIC/S, WHO, and Chinese regulated markets.U.S. and Europe that involve industry trends and changing regulatory policy.
The course will include current case studies on a wide array of facility topics as well as a class exercise in developing a facility scope of work and deliverables.
Course Training Modules
- GMPs expectations for Cross-contamination Control. Introduction and comparison.
- Occupational Health and Safety meets the GMPs.
- Risk Assessment Techniques – Practical aspects of FMEA to rank risks.
- The use of ADI (allowable daily intake) for assessment of acceptable Cross-contamination.
- Introduction to ISPE’s RiskMaPP Baseline Guide™ for Cross-contamination management.
- Techniques for Containment and occupational Health exposure testing.
- Cross-contamination control strategies and techniques.
- Industry Trends.
- Impact on facility design and operation.
Course Workshop Sessions
Working in Groups
- Session 1: For a given set of unit processes, evaluate the routes / vectors and potential pathways that could lead to cross-contamination.
- Session 2: Use FMEA techniques to rank the risks by criticality.
- Session 3: Identify mitigation measures you might use to achieve acceptable control.
Learning Objectives
- Identify routes/vectors that can lead to a Cross-contamination risk.
- Understand the principles of Risk assessment and management, including ISPE’s Baseline Guide™ RiskMaPP.
- Work on real process operations to understand vectors, risks, probability, severity, and mitigation measures.
- Learn about trends in industry practice.
- Find out how to test the performance of containment systems with a focus on Occupational Health and Cross-contamination control.
Who Should Attend
- Individuals who need to understand the aspects of “Risk Based” GMPs for the 21st Century.
- Individuals who want to improve their working knowledge of pharmaceutical manufacturing facility design and operational concepts.
- Professionals who need a focused understanding of the issues a pharmaceutical manufacturing company must address when designing a facility that meets current regulatory requirements and corporate safety.
- Individuals who provide services and/or assistance to pharmaceutical manufacturing companies to design, construct, validate, and finance facilities.
Course and Workshop leader:
Gordon Farquharson
Gordon Farquharson, BSc (Hons), CEng is a Chartered Consulting Engineer with more than 30 years of experience in quality and safety critical processes and facilities used by industries such as healthcare, life science, micro-electronics, etc. He is Principal of Critical Systems Ltd, and Executive Consultant with PharmOut Pty Ltd, international consultancy businesses. Farquharson has been responsible for the development of technical solutions in discovery, research, product/process development, primary manufacturing, and device and dosage form manufacturing. Standards and regulatory compliance in the sector are a significant interest and responsibility. He is Chairman of UK BSI and CEN Technical Committees for cleanroom standards, Convenor of the ISO working group that is revising ISO 14644-1 and 2. He has recently represented ISPE and CEN, working on the EMEA’s revision of Annex 1 of the EU GMP. He has also supported ISPE by writing WHO’s new Pharmaceutical Water GMP Guidance, and has been active developing and revising ISPE Baseline® Guides. Farquharson is a past chair of the ISPE European Education Committee and current member, a founder of the Sterile Products Processing COP, and was voted ISPE International Member of the Year in 2001, UK Affiliate Member of the Year 2008, and received the Richard B. Purdy Distinguished Achievement Award in 2009. He is a frequent speaker and trainer for ISPE worldwide.
Booking Closed
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Day 4 - Essential GMP Documentation, Quality Manuals, Policies, SOPs and MBR
Date: |
01 December 2011 |
|---|---|
Location: |
The Cityview, 5F Diamond Room. |
Address: |
23 Waterloo Road, Kowloon, Hong Kong |
Function Time: |
0900-1700hrs |
Pricing: |
HK $2000 |
Overview
This one day course is suitable for people who are interested in the design and implementation of a quality management system which comprises quality assurance, Good Manufacturing Practice, quality control and quality risk management attributes.
The course will include practical case studies and exercises to enhance the learning process.
Subjects covered throughout the day
- Overview of Quality Management System (QMS)
- basis for developing and implementing a quality system
- Implementation of a risk-based approach QMS.
- Review of Quality Policy & Management.
- Preparation of Quality Manual and an effective documentation system.
- Documentation and Change Control
- Review and revise CAPA system
- Review and revise change management system
- Review and revise deviation management system
- Preparation of protocol and SOPs for Product Quality Review
- Set up of vendor qualification program and approved vendor list for API
- Review of Quality Risk Management (QRM)
- Concept of QRM
- Application in daily operations
- Role of internal audit/self-inspection
Who should attend?
- Quality Assurance or Compliance Personnel
- Site Quality Manager
- Document Controller
About the trainers
PharmOut's Managing Director, Trevor Schoerie has 21 years of manufacturing and 8 years of consulting experience in the chemical, pharmaceutical, pesticides & veterinary drugs industries.
Trevor believes strongly in sensible, practical compliance that delivers business results, not just audit success.
His area of expertise is in combining Good Manufacturing Practice (GMP) compliance with continuous improvement methods such as Lean Manufacturing.
Nai Yee (Ann) Choong, has a science degree in microbiology and has worked as a formulation scientist, in regulatory affairs, and more recently as a GMP auditor. Ann is well versed with the current PIC/S Guide to Good Manufacturing Practice (GMP) for Medicinal Products.
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Day 5 - Validation - Process and Equipment
Date: |
02 December 2011 |
|---|---|
Location: |
The Cityview, 5F Diamond Room. |
Address: |
23 Waterloo Road, Kowloon, Hong Kong |
Function Time: |
0900-1600hrs |
Pricing: |
HK $2000 |
Overview
This one day course is designed for people who need an strong grounding in Process and Equipment validation within a GMP-regulated industry.
As the PICS Guide to Good Manufacturing Practice for Medicinal Products states;
“Validation studies should reinforce Good Manufacturing Practice and be conducted in accordance with defined procedures. Results and conclusions should be recorded.
When any new manufacturing formula or method of preparation is adopted, steps should be taken to demonstrate its suitability for routine processing. The defined process, using the materials and equipment specified, should be shown to yield a product consistently of the required quality.
Significant amendments to the manufacturing process, including any change in equipment or materials, which may affect product quality and/or the reproducibility of the process should be validated.”
What you will learn
Upon completion of this course participants will;
- Understand the importance of validation and why and how the information is collected and used.
- Have an understanding of the V model and how it is used.
- Know what Validation Master Plans (VMP), User Requirements Specifications, Functional Specifications and Design Specifications are and how and when to use them.
- Know the steps involved in Installation Qualification, Operational Qualification and Performance Qualification
- Have an understanding of the essentials of process validation.
- Know what is meant by CQA’s and CPP’s and their relevance to process validation.
- Understand the “risk based” validation approach and how best to apply it.
- Know what a Validation Summary Report is and when it should be used.
-
Ensure your validation efforts add value to your organisation and gather critical knowledge for you and your organisation.
Who should attend?
- Validation personnel
- Quality Control personnel
- Operations or Manufacturing personnel
- Engineering personnel
About the trainers
John Montalto has extensive experience as a course facilitator within pharmaceutical, medical device and life sciences industries, specialising in all aspects of GMP (PIC/s, TGA, WHO, FDA). His expertise is within project management, adult training and driving process improvement initiatives, including plant and process validation, scale up and commissioning. John is also an equipment/validation specialist with significant experience in pharmaceutical, chemical and health care manufacturing industries.
Marc Fini is a pharmaceutical professional with over 15 years experience in operations, validation, regulatory compliance and small to large scale projects. Marc has recent experience in dealing with pharmaceutical operations in Hong Kong which gives him an insight into developing validation requriements specifically for Hong Kong.
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