Needs Assessment
The Food and Drug Administration (FDA) requires that all biotechnology companies produce and maintain detailed records of every test, process, and procedure involved in researching, developing, manufacturing, and marketing products. FibroGen needed to ensure that all its regulated clinical processes and procedures were documented and in full regulatory compliance.

HIPAA Privacy Expert for the California Department of Health Services
The Health Insurance Portability and Accountability Act (HIPAA) implements security procedures to ensure the confidentiality of health information and data. To be in compliance with HIPAA laws, the California Department of Health Services needed a Business Analyst and Technical Writer to prepare internal feasibility study reports.

Standard Operating Procedures
As part of its global ERP implementation (SAP R/5) Amgen needed to document a wide variety of global processes. This required a background in specific areas of the enterprise, as well as expertise in working within a federally-regulated environment.

SAP E-Learning and Instructor-Led Training
The Abgenix SAP implementation affected hundreds of employees at all levels of the company. Specific job functions were changing, and Abgenix needed to develop SAP self-study, e-learning modules for multiple procedures throughout the organization.

SAP Procedures-Work Instructions
The Abgenix SAP implementation affected hundreds of employees at all levels of the company. Specific job functions were changing, and Abgenix needed to develop SAP work instructions for hundreds of procedures. These procedures needed to be compliant with Federal regulations for each job function. In addition, Abgenix wanted to develop a compatible series of SAP e-learning modules to supplement these procedures.

E-Learning HIPAA Overview
In 1996, Congress passed the Health Insurance Portability & Accountability Act (HIPAA). The purpose of the legislation is to provide increased portability of health insurance through limitation on preexisting condition exclusions, prevention of health care fraud and abuse, protection of patient information, establishment of standards for electronic systems handling medical information including privacy, security, transaction codes and handling procedures.

PeopleSoft Training Analysis
TechProse worked with PriceWaterhouse Coopers (PWC) and their client Safeco during their PeopleSoft implementation.  As the implementation proceeded, questions arose as to the best methodology to train a diverse array of corporate and remote personnel on the new system.  PWC asked TechProse to perform a Training Analysis to determine the best path forward for training development and delivery.

Blended Learning
PacifiCare Health Systems (PHS) required training for a wide variety of employees, regarding benefits for the elderly and their families and new programs and offerings under the Medicare Part D initiative. New Medicare prescription programs required rapid training of a wide variety of geographically distributed agents and call center employees.

Controlled Documents for SAP R/5 Global Implementation
Amgen’s SAP global implementation program required Controlled Documents used in association with critical business functions to ensure compliance with US and international regulations as well as company standards.  The documents spanned work streams including Supply Management, Human Capital Management, and SAP IT Operations.

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