2013 Atlanta Training, June 2014

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Education Details

Training Courses 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 are:

Combination Products (T47)
Instructor: Janet Bowen

An overview and the intricacies of the GMPs for combination products will be provided that specifically address the challenges and expectations from industry and global regulatory agencies. The development of the basis for the product, testing, and specifications including identifying design inputs, user requirements and design requirements as starting points to the development process will be reviewed in detail.

Science and Risk Based Commissioning and Qualification (T40) 
Instructor: Steve Wisniewski

Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8, Q9, and Q10 and ASTM E-2500.

Turning QbD into a Practical Reality (T43) 
Instructor: Stephen M. Tyler

This interactive training course utilizes the ISPE PQLI Guide Series: Part 1 - Product Realization using Quality by Design, Concepts and Principles and Part 2 - Product Realization using Quality by Design, Illustrative Example as the basis for explaining and providing examples of how products and processes can be developed, using QbD with special emphasis on the considerations for implementing these processes in manufacturing.

Basic Principles of Computerized Systems Compliance using GAMP®5, Including Revised Annex 11 and Part 11 Update (T45)
Instructor: Jim John

This three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements.

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

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.

Sterile Product Manufacturing Facilities: Apply the new ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation (T12)
Instructor: Mark von Stwolinski

This course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities.

Technology Transfer (T19) - New Course
Instructor: John Herberger

This course identifies criteria for successful Technology Transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer. It takes into account current industry challenges and real-world examples as tools for industry and regulators to use when conducting and evaluating technology transfer activities.

This indicates that the course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course.

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.

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