Connecting a World of Pharmaceutical Knowledge
Courses • Applying Quality Risk Management • Basic Computerized Systems Compliance GAMP® 5 • Biopharmaceutical Manufacturing Processes • Cleaning Validation Principles • Facility Project Management* • HVAC • Managing the Risk of Cross Contamination • Oral Solid Dosage Forms • Pharmaceutical Water Generation
• Practical Application of Computerized Systems Compliance GAMP® 5
• Science and Risk-Based Commissioning and Qualification
• Practical Implementation of Process Validation Lifecycle Approach
• Sterile Product Manufacturing Facilities
• Process Validation in Biotechnology Manufacturing • Q7A: Implementing Good Manufacturing Practices
• Storage, Delivery & Qualification of Pharmaceutical Waters • Technology Transfer • Turning QbD into a Practical Reality
• Risk Based Approach to GxP Process Control Systems GAMP® 5 • Risk-Based Verification of Facilities, Systems & Equipment
Meet your regulatory requirements with ISPE Training: Classroom, On-site & On-line Register Today at ISPE.org/Training
Why ISPE Training? Real World Practice: Courses present exercises that use current problems and situations common to the industry. Experienced Instructors are subject matter experts and top leaders who have years of experience in the field. Interactive Courses are taught in an engaging, lively format based on useful actionable information obtain through relevant case studies, exercises and workshops.
• Current trends and standards, new operational procedures and state-of-the-art technologies you need to improve operations, decrease errors and lower costs.
Courses provide: • Integration and understanding of Regulatory Guidance
2015 ISPE Training Courses
such as ICH Q7 Active Pharmaceutica Ingredients, ICH •A dvantages and disadvantages of different methodologies Q8 Pharmaceutical Development, ICH Q9 Quality Risk including alternative approaches for operational procedures Management, ICH Q10 Pharmaceutical Quality Systems, and facility design. ICH Q11 Development and Manufacture of Drug Substance, • M any courses include ISPE Guidance documents which USFDA Process Validation Guidance, Annex 11 and provide the practical, "real world" information needed to Harmonization. build on best practices so you can take your work to the • In-depth understanding of how and why processes work. next level.
Online Training Course
Philadelphia PA 14-16 Sep
Barcelona, Spain 28-30 Sep
Manchester, UK 12-14 Oct
Boston, MA 19-23 Oct
C ontact ISPE Member Services at 1-813-960-2105 or via email at
[email protected]
Raleigh, NC 19-20 Oct
Philadelphia, PA 9-10 Nov
Tampa, FL 7-10 Dec
ISPE Training Institute Tampa, FL Oct
Biotechnology
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Bio Manufacturing Facilities (T31) Biotechnology Basics Biopharmaceutical Manufacturing Facilities
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Biopharmaceutical Manufacturing Processes (T24) Production Unit Operations drug & biologics Process Validation in Biotech Manufacturing
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Cleaning
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Cleaning Validation Principles (T17)
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Commissioning and Qualification C&Q as a Risk Management Strategy Facilities, Systems and Equipment Workshop (T48)
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2015 ISPE Training Courses Risk-Based Facilities, Systems and Equipment
Online Training Course
Philadelphia PA 14-16 Sep
Barcelona, Spain 28-30 Sep
Manchester, UK 12-14 Oct
Boston, MA 19-23 Oct
Raleigh, NC 19-20 Oct
Philadelphia, PA 9-10 Nov
Tampa, FL 7-10 Dec
ISPE Training Institute Tampa, FL Oct
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Science and Risk-based C & Q (T40)
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GAMP
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A GAMP Approach to Data Integrity (T50) Application of Computerized Systems Compliance (T11)
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Basic GAMP® 5, Annex 11 / Part 11 Update (T45) Basic Principles of Computerized Systems Compliance Calibration Management
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Complying with Part 11 - Risk Management: Applying the GAMP® Good Practice Guide Electronic Records and Signatures Principles
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Controls and Automation
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GxP Process Control Systems (T21) Information Systems
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Good Manufacturing Practice GMP Auditing for the Pharmaceutical Industry
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GMP Auditing for the Pharmaceutical Industry (G07) GMP Inspection Approach to Facilities and Equipment
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GMP Inspection Approach for Laboratory Control Systems
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GMP Inspection Approach for Materials Systems
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2015 ISPE Training Courses GMP Inspection Approach for Packaging and Labeling GMP Inspection Approach for Production Systems GMP Inspection Approach to Quality Systems Government Regulations
Online Training Course
Philadelphia PA 14-16 Sep
Barcelona, Spain 28-30 Sep
Manchester, UK 12-14 Oct
Boston, MA 19-23 Oct
Raleigh, NC 19-20 Oct
Philadelphia, PA 9-10 Nov
ISPE Training Institute Tampa, FL Oct
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Q7A: Implementing Good Manufacturing Practices (T30) Standards, Practices and Guides
Tampa, FL 7-10 Dec
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HVAC
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HVAC (T14)
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Manufacturing
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Applying Quality Risk Management (QRM) (T42) Containment Fundamentals Formulation, Clinical Phases, and Manufacturing Industry Overview: Drug Dosage Forms
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Managing the Risk of Cross Contamination (T41) Materials Management Operational Economics Operation and Maintenance
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Oral Solid Dosage Forms (T10)
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Practical Application of Technology Transfer (T19) Production Control Production Management
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2015 ISPE Training Courses
Online Training Course
Production Scale-up and Optimization
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Risk-MaPP: What It Is and Why You Need It
Barcelona, Spain 28-30 Sep
Manchester, UK 12-14 Oct
Boston, MA 19-23 Oct
Raleigh, NC 19-20 Oct
Philadelphia, PA 9-10 Nov
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Sterile Product Manufacturing Facilities (T12) Technology Transfer
Philadelphia PA 14-16 Sep
Tampa, FL 7-10 Dec
ISPE Training Institute Tampa, FL Oct
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Project Management Design and Construction/Installation
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Facility Project Management (T26)*
Quality by Design PQLI: From Concept to Continual Improvement Risk Management and Quality Management Systems
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Turning QbD into a Practical Reality (T43)
Validation Practical Implementation of Process Validation Lifecycle Approach (T46)
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Process Validation in Biotech Manufacturing (T32) System Validation
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Water Introduction to Water and Steam (2nd Edition)
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Pharmaceutical Water Generation (T04)
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Storage Delivery and Qualification of Pharmaceutical Waters (T23)
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*ISPE has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI®) Page 5
