Courses. Meet your regulatory requirements with ISPE Training: Classroom, On-site & On-line. Register Today at ISPE.org/Training

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Emory Grant
7 years ago
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1 Connecting a World of Pharmaceutical Knowledge s 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 Practical Implementation of Process Validation Lifecycle Approach Process Validation in Biotechnology Manufacturing Q7A: Implementing Good Manufacturing Practices Risk Based Approach to GxP Process Control Systems GAMP 5 Risk-Based Verification of Facilities, Systems & Equipment Science and Risk-Based Commissioning and Qualification Sterile Product Manufacturing Facilities Storage, Delivery & Qualification of Pharmaceutical Waters Technology Transfer Turning QbD into a Practical Reality Meet your regulatory requirements with ISPE : Classroom, On-site & On-line Register Today at ISPE.org/

2 Why ISPE? Real World Practice: s 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 s are taught in an engaging, lively format based on useful actionable information obtain through relevant case studies, exercises and workshops. s provide: Integration and understanding of Regulatory Guidance such as ICH Q7 Active Pharmaceutica Ingredients, ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality Systems, ICH Q11 Development and Manufacture of Drug Substance, USFDA Process Validation Guidance, Annex 11 and Harmonization. I n-depth understanding of how and why processes work. Current trends and standards, new operational procedures and state-of-the-art technologies you need to improve operations, decrease errors and lower costs. Advantages and disadvantages of different methodologies including alternative approaches for operational procedures and facility design. Many courses include ISPE Guidance documents which provide the practical, "real world" information needed to build on best practices so you can take your work to the next level. Contact ISPE Member Services at or via at ask@ispe.org ISPE Biotechnology Bio Manufacturing Facilities (T31) Biotechnology Basics Biopharmaceutical Manufacturing Facilities Biopharmaceutical Manufacturing Processes (T24) Production Unit Operations drug & biologics Process Validation in Biotech Manufacturing Cleaning, Cleaning Validation Principles (T17) Commissioning and Qualification C&Q as a Risk Management Strategy Facilities, Systems and Equipment Workshop (T48) ISPE

3 Risk-Based Facilities, Systems and Equipment, Science and Risk-based C & Q (T40) GAMP A GAMP Approach to Data Integrity (T50) Application of Computerized Systems Compliance (T11) Basic GAMP 5, Annex 11 / Part 11 Update (T45) Basic Principles of Computerized Systems Compliance Calibration Management Complying with Part 11 - Risk Management: Applying the GAMP Good Practice Guide Electronic Records and Signatures Principles Controls and Automation GxP Process Control Systems (T21) Information Systems Good Manufacturing Practice GMP Auditing for the Pharmaceutical Industry GMP Auditing for the Pharmaceutical Industry (G07) GMP Inspection Approach to Facilities and Equipment GMP Inspection Approach for Laboratory Control Systems GMP Inspection Approach for Materials Systems ISPE

4 GMP Inspection Approach for Packaging and Labeling GMP Inspection Approach for Production Systems GMP Inspection Approach to Quality Systems Government Regulations Q7A: Implementing Good Manufacturing Practices (T30) Standards, Practices and Guides HVAC, HVAC (T14) Manufacturing Applying Quality Risk Management (QRM) (T42) Containment Fundamentals Formulation, Clinical Phases, and Manufacturing Industry Overview: Drug Dosage Forms Managing the Risk of Cross Contamination (T41) Materials Management Operational Economics Operation and Maintenance Oral Solid Dosage Forms (T10) Practical Application of Technology Transfer (T19) Production Control Production Management ISPE

5 Production Scale-up and Optimization Risk-MaPP: What It Is and Why You Need It, Sterile Product Manufacturing Facilities (T12) Technology Transfer Project Management Design and Construction/Installation Facility Project Management (T26)* Quality by Design PQLI: From Concept to Continual Improvement Risk Management and Quality Management Systems Turning QbD into a Practical Reality (T43) Validation Practical Implementation of Process Validation Lifecycle Approach (T46) Process Validation in Biotech Manufacturing (T32) System Validation Water Introduction to Water and Steam (2nd Edition) Pharmaceutical Water Generation (T04) Storage Delivery and Qualification of Pharmaceutical Waters (T23) ISPE *ISPE has been reviewed and approved as a provider of project management training by the Project Management (PMI )

Library Guide: Pharmaceutical GMPs

Library Guide: Pharmaceutical GMPs Table of Contents Overview...3 Courses Listed by Functional Area... 4 Course Descriptions: A Step-by-Step Approach to Process Validation (PHDV79)... 7 A Tour of the FDA