2013 Indianapolis Training, May 2014

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Education Details

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 are:

Monday - Tuesday, 19-20 May

Cleaning Validation Principles (T17)  
Instructor: Becky Brewer

As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. FDA's risk-based regulatory initiatives focus new attention on the risks of cross-contamination.

Clinical Trial Materials: Applying Production, Quality Assurance and Packaging Processes (T13) 
Instructor: David Glynn

In this course, you will receive a thorough overview of the clinical supply chain from beginning to end, including: designing appropriate packaging and labeling to match the study design, creating a plan of action to prepare the CTM and how to implement the plan and troubleshoot.

Monday - Tuesday - Wednesday, 19-21 May

Basic Principles of Computerized Systems Compliance Using GAMP® 5 (T45) 
Instructor: Kate Townsend

This course has been updated to include the new revised EU GMP Annex 11, and an update on 21 CFR Part 11.

Tuesday - Wednesday - Thursday, 20-22 May

Control for Critical Environments: HVAC Design Concepts - (T14) New Course 
Instructor: Norm Goldschmidt

This course provides insight into the theoretical basis and practical application of environmental control for Pharmaceutical, Biotechnology, Vaccine, Medical Device and Combination Device companies.

Wednesday - Thursday, 21-22 May

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

Oral Solid dosage forms (Tablets and Capsules) are some of the most popular and convenient methods of drug delivery. They can be produced in a non-sterile environment and the process, equipment and technology is well defined and known, after more than 100 years of development.

Process Validation Lifecycle - Integration to the Pharmaceutical Quality System (T46)
Instructor: Yanhui Hu

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.

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.

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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