This two-day course provides proven techniques for reducing costs associated with implementing, using, and maintaining computer systems. Nearly every computerized system utilized in laboratory, clinical, manufacturing and the quality process has to be validated. Finding efficiencies without weakening the quality position is essential in order to be competitive. This course benefits people that use computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device markets. Participants should have good computer skills and some experience in a GxP environment.
* Decrease software implementation times and lower costs using the proven risk-based computer system validation approach. It consists of 10-steps that use easy to understand fill-in-the-blank templates.
* Validation documentation templates are provided so you will have what the FDA expects for compliant software.
* Use resources effectively to perform effective validation while avoiding doing too much.
* Many companies are downsizing which makes more work for the remaining staff. Learn how to "right size" and minimize the validation documentation to reduce costs without increasing regulatory or business risk.
* Learn how to quickly cross train workers.
* Take advantage of temporary workers and outsourcing to promote growth and reduce costs.
* Understand software vendor claims and the deficiencies of their validation packages.
* Step by step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation requirements.
* Ensure data integrity and protect intellectual property by using computer system industry standards for data security, data transfer, and audit trails.
* The instructor uses real-world examples and in-class exercises to illustrate the 21 CFR Part 11 regulation for electronic records and electronic signatures in FDA-regulated activities, including clinical trials and pharmaceutical manufacturing. Included are the HIPAA electronic security regulations for patient medical records.
* Learn how to implement a computer system to gain maximum productivity.
* Review recent FDA inspection trends and validation errors; avoid 483s and Warning Letters.
* Reduce testing by writing test cases that trace to elements of risk management.
* "Right size" change control methods that allows quick and safe system evolution while maintaining systems in a validated state.
* Streamline SOP authoring, revision, review, and approval.
* Participants learn valuable skills that make them more efficient users of any type of computer system.