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"New Strategies and Business Benefits"

ISPE Frankfurt 2011 Conference will represent an opportunity to boost
your pharmaceutical engineering career!
• Participate in interactive Seminar sessions and panel disucssions
• Listen to Keynote Speakers with insights into regulatory affairs or
  changing operating environments
• Obtain updates on industry and regulatory trends
• Real-life case studies, "hands-on" workshop exercises and technical
  updates
• Expand your expertise with in-depth trainings on HVAC and GAMP®
  GxP Risk-Based Approach to Control Systems
OSD Manufacturing: Facility and Technology Advances                 11-12 April 2011
2-day Seminar providing participants with comprehensive insight into the world of OSD
multiproduct/multipurpose manufacturing. Click here for details and programme!

Seminar Highlights
        •   2 workshops:
              Process and Facilities
              Outsourcing and local market manufacture
        •   Case studies covering new industry trends


Quality Risk Management: Focused, Practical               11-12 April 2011
Learn how to document QRM effectively with this 2-day Seminar giving practitioners a
platform to share experiences and swap ideas. Click here for details and programme!

Seminar Highlights
        •   Real-life Case studies
        •   Interactive Workshop exercises
        •   Panel Disussions
Sterile Product Manufacturing: Maintaining Compliance                  11-12 April 2011
This Seminar will address ways of using technology to reduce costs, improve quality, and
meet market demands. Click here for details and programme!

Seminar Highlights
        •    High-profile Keynote speaker Tor Graberg, Chairman of PIC/S, and EU Green
             Expert, Charlotte Unger, MPA, will share their insights into maintaining
             compliance, technological and regulatory requirements
        •    Industry Best Practices Case studies
        •    Panel Disussions

Regulatory Affairs Forum         13 April 2011
The Regulatory Affairs Forum will offer participants an opportunity to join representatives
of EMA, FDA, MPA, NHIS and other regulatory agencies in dialogue over critical quality
compliance and review topics. Click here for details and programme!

Seminar Highlights
Interactive Panel Discussion – Submit your questions and disucss issues on all quality
related topics with high-profile regulatory speakers providing updates on current and future
intiatives impacting the global industry.
GAMP®: IT Infrastructure Innovation and Compliance                   13-14 April 2011
2-day Seminar exploring the innovations in IT infrastructure services and solutions and the
resultant impact on industry’s approach to compliance. Click here for details and programme!

Seminar Highlights
        •    Real-life Case studies / "Hands-on" Workshop exercises
        •    Interactive Panel Discussion and Regulatory Updates



Pharmaceutical Water Systems:
Cost Effective Design and Maintenance Trends                  13-14 April 2011
Practical and relevant insights from industry end-users, experts, and engineers will be
featured in this 2-day Seminar. Click here for details and programme!

Seminar Highlights
        •    Seminar sessions on Production of WFI, Risk-Based Maintenance for Pharma
             Water Systems, Good and Bad Storage, Greener Manufacturing
        •    Interactive Workshop exercises
Supply Chain Integration to Maximise Profit and Compliance                 13-14 April 2011
2-day Seminar addressing best practices in optimising manufacturing and supply chain
operations. Click here for details and programme!

Seminar Highlights
        •   Join Keynote Speaker Jim McKiernan on the Challenges facing Pharma Supply
            Chains
        •   Join leading experts on the topics of Commercial and Demand Management,
            Product Lifecycle Management, Supply Chain Transformation, Effective Product
            Launches, …
HVAC for Pharmaceutical Facilities              13-15 April 2011 / CEUs: 2
Identify the critical and non-critical parameters affected by HVAC and know-how to control
them. Describe HEPA filter theory, application, monitoring, testing and repair. Examine
typical designs for bulk, oral solid dosage, sterile, biopharmaceutical, packaging and
warehousing operations.
Immediately apply the course objectives using the ISPE Good Practice Guide: Heating,
Ventilation, and Air Conditioning.
Click here for course details!



GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process
Control Systems 14-15 April 2011 / CEUs: 1.5
Using practical hands-on workshop exercises and a range of case study examples, this highly
interactive course describes how the GAMP® Good Practice Guide: A Risk-Based Approach to
GxP Process Control Systems (2nd Edition) can be applied to achieve process control systems
that are fit for intended use and meet current regulatory requirements.
Immediately apply the course objectives using the complimentary copy of the GAMP® Good
Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition)
Click here for course details!
Sponsorship and Exhibition Opportunities

The Frankfurt Conference 2011 will provide your company with a platform to MEET key
decision makers in the industry, international speakers and society leaders.
PRESENT your company and introduce your services and products to engineers, project
managers, professionals in the area of process development, validation, clinical supplies,
manufacturing operations and corporate management; and active professionals eager to
discover innovative technologies. The Conference will MAXIMISE your visibility and convey
your message through different channels.
The package includes:
•   Your company name featured in the Exhibitor Directory
•   Face-to-face time with delegates during three coffee breaks, two standing lunches and
    a networking reception
•   One-day guest pass for the exhibition
•   First access to the delegate list prior to the event
•   15% discount for table top personnel to attend a Seminar session
For more details, click here!
For more details, visit
    ISPE Frankfurt Conference 2011

See you at the Conference in Frankfurt!

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New Strategies and Business Benefits Conference

  • 1. "New Strategies and Business Benefits" ISPE Frankfurt 2011 Conference will represent an opportunity to boost your pharmaceutical engineering career! • Participate in interactive Seminar sessions and panel disucssions • Listen to Keynote Speakers with insights into regulatory affairs or changing operating environments • Obtain updates on industry and regulatory trends • Real-life case studies, "hands-on" workshop exercises and technical updates • Expand your expertise with in-depth trainings on HVAC and GAMP® GxP Risk-Based Approach to Control Systems
  • 2. OSD Manufacturing: Facility and Technology Advances 11-12 April 2011 2-day Seminar providing participants with comprehensive insight into the world of OSD multiproduct/multipurpose manufacturing. Click here for details and programme! Seminar Highlights • 2 workshops:  Process and Facilities  Outsourcing and local market manufacture • Case studies covering new industry trends Quality Risk Management: Focused, Practical 11-12 April 2011 Learn how to document QRM effectively with this 2-day Seminar giving practitioners a platform to share experiences and swap ideas. Click here for details and programme! Seminar Highlights • Real-life Case studies • Interactive Workshop exercises • Panel Disussions
  • 3. Sterile Product Manufacturing: Maintaining Compliance 11-12 April 2011 This Seminar will address ways of using technology to reduce costs, improve quality, and meet market demands. Click here for details and programme! Seminar Highlights • High-profile Keynote speaker Tor Graberg, Chairman of PIC/S, and EU Green Expert, Charlotte Unger, MPA, will share their insights into maintaining compliance, technological and regulatory requirements • Industry Best Practices Case studies • Panel Disussions Regulatory Affairs Forum 13 April 2011 The Regulatory Affairs Forum will offer participants an opportunity to join representatives of EMA, FDA, MPA, NHIS and other regulatory agencies in dialogue over critical quality compliance and review topics. Click here for details and programme! Seminar Highlights Interactive Panel Discussion – Submit your questions and disucss issues on all quality related topics with high-profile regulatory speakers providing updates on current and future intiatives impacting the global industry.
  • 4. GAMP®: IT Infrastructure Innovation and Compliance 13-14 April 2011 2-day Seminar exploring the innovations in IT infrastructure services and solutions and the resultant impact on industry’s approach to compliance. Click here for details and programme! Seminar Highlights • Real-life Case studies / "Hands-on" Workshop exercises • Interactive Panel Discussion and Regulatory Updates Pharmaceutical Water Systems: Cost Effective Design and Maintenance Trends 13-14 April 2011 Practical and relevant insights from industry end-users, experts, and engineers will be featured in this 2-day Seminar. Click here for details and programme! Seminar Highlights • Seminar sessions on Production of WFI, Risk-Based Maintenance for Pharma Water Systems, Good and Bad Storage, Greener Manufacturing • Interactive Workshop exercises
  • 5. Supply Chain Integration to Maximise Profit and Compliance 13-14 April 2011 2-day Seminar addressing best practices in optimising manufacturing and supply chain operations. Click here for details and programme! Seminar Highlights • Join Keynote Speaker Jim McKiernan on the Challenges facing Pharma Supply Chains • Join leading experts on the topics of Commercial and Demand Management, Product Lifecycle Management, Supply Chain Transformation, Effective Product Launches, …
  • 6. HVAC for Pharmaceutical Facilities 13-15 April 2011 / CEUs: 2 Identify the critical and non-critical parameters affected by HVAC and know-how to control them. Describe HEPA filter theory, application, monitoring, testing and repair. Examine typical designs for bulk, oral solid dosage, sterile, biopharmaceutical, packaging and warehousing operations. Immediately apply the course objectives using the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning. Click here for course details! GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems 14-15 April 2011 / CEUs: 1.5 Using practical hands-on workshop exercises and a range of case study examples, this highly interactive course describes how the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition) can be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. Immediately apply the course objectives using the complimentary copy of the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition) Click here for course details!
  • 7. Sponsorship and Exhibition Opportunities The Frankfurt Conference 2011 will provide your company with a platform to MEET key decision makers in the industry, international speakers and society leaders. PRESENT your company and introduce your services and products to engineers, project managers, professionals in the area of process development, validation, clinical supplies, manufacturing operations and corporate management; and active professionals eager to discover innovative technologies. The Conference will MAXIMISE your visibility and convey your message through different channels. The package includes: • Your company name featured in the Exhibitor Directory • Face-to-face time with delegates during three coffee breaks, two standing lunches and a networking reception • One-day guest pass for the exhibition • First access to the delegate list prior to the event • 15% discount for table top personnel to attend a Seminar session For more details, click here!
  • 8. For more details, visit ISPE Frankfurt Conference 2011 See you at the Conference in Frankfurt!