Course DescriptionNearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential.
This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Attendees will learn how to decrease software implementation time and lower costs using a
10-step risk-based approach to computer system validation.The instructor addresses the
latest computer system industry standards for data security, data transfer, and audit trails.Attendees will see how 21 CFR Part 11, the FDA regulation pertaining to use of electronic records and signatures, and the HIPAA electronic security regulations for patient medical records fit into the validation process. Finally, the instructor will review recent FDA inspection trends and discusses how to streamline SOP authoring, revision, review, and approval.
This course benefits anyone that uses 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 sectors.
Location: The Hilton San Diego Resort & Spa, 1775 East Mission Bay Drive, San Diego, CA 92109
Course Objectives: - Implement a computer system to gain maximum productivity and reduce cost by as much as two thirds
- Quickly cross train workers and see how to make use of temporary workers and outsourcing to promote growth and reduce costs
- "Right size" change control methods that allows quick and safe system evolution
- Minimize the validation documentation to reduce costs without increasing regulatory or business risk
- Write test cases that trace to elements of risk management
- Protect intellectual property and keep electronic records safe
Who Will Benefit:Companies that maintain electronic medical records. Personnel who will benefit include:
- QA Directors, Managers and personnel
- IT / IS managers and personnel
- Software validation and software quality managers + personnel
- Consultants charged with creating or evaluating part 11 programs
- Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
- Quality auditors responsible for auditing and evaluating part 11 compliance
- Users of computer systems in FDA regulated environments
- Ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, laboratory, manufacturing, pharmaceutical, biotechnical, and medical device markets
- Also ideal for software developers and software vendors
- Participants learn valuable skills that make them more efficient users of any type of computer system
Note: Use this promocode(
117660) for 10% discount.
