2013 Washington DC Training2013 Washington DC Training2013 Washington DC Training

Education Details

5-6 November

Training Courses are two-day events that are a great place for your employees to work interactively with industry experts and peers to gain valuable skills and knowledge. Our instructors work in the industry and face the same daily challenges you do.

Training Courses

Practical Application of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-based Approach to Compliant GxP Computerized Systems (T11)

This highly interactive workshop gives participants hands-on experience in applying practical techniques and solutions to solve computerized systems compliance challenges. Participants will discuss and analyze case studies, apply newly acquired knowledge to hypothetical case-study systems, and have the opportunity to discuss their own real-life challenges with other participants and an expert trainer.

Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline® Guide (T41)

This course will focus on using the logic diagram, how health based limits are developed, setting cleaning validation limits, risk assessments for cross contamination and formulating a Quality Risk Management Plan as part of a Quality System.

Process Validation Lifecycle and the Pharmaceutical Quality System (T46) - New Course!

This course is relevant to individuals involved throughout the product lifecycle in validation of products and processes, in establishing and implementing Process Performance, Product Quality Monitoring, and Change Management systems in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management.

Oral Solid Dosage Forms: Understanding the Unit Operations, Process, Equipment and Technology for OSD Manufacture (T10)

The course uses a Process and Production Simulation for Unit Ops, including Mixing, Blending, Drying, Sizing, Tableting, Encapsulation and Coating to provide participants with a demonstration of current manufacturing and engineering practices. Troubleshooting through video simulation will vividly provide real-time experiences for identifying the problem, analyzing the problem and solving the problem.

Continuing Education Units (CEUs)

ISPE will provide continuing education units (ISPE CEUs) for all North American courses. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials.

Certified Pharmaceutical Industry Professional™ (CPIP™)

Some courses contain knowledge related to the CPIP™ Technical Knowledge and Competency Elements. For complete information concerning the knowledge elements or the CPIP™ Credential, please visit www.ISPE-PCC.org. The ISPE Professional Certification Commission does not endorse any of these resources, products, or services offered relative to the CPIP™ certification program.

Thank you to our Top Tier Sponsors

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