Unit 5: Documenting Excellence: Mastering Practices for Compliance and Clarity
Participants will learn how to describe and apply best practices for documentation to ensure clarity, accuracy, and regulatory compliance. The course will highlight required documentation for sterile compounding, including personnel training records, competency assessments, and equipment documentation. Attendees will also explore strategies for maintaining documents that meet legal and regulatory requirements while protecting their integrity and accessibility. By the conclusion of the session, learners will be prepared to manage documentation processes effectively to support safe, compliant, and high-quality compounding operations.
Learning Objectives:
- Identify key USP <797> documentation requirements for compounded sterile preparations.
- Apply proper techniques for correcting documentation errors while maintaining traceability.
- Design compliant systems for document retention, retrieval, and accessibility.
- Document staff competencies, training, and qualifications accurately and completely.
Jacob Deitsch, PharmD, BCPS, BCSCP, HDDP, IgCP
Director of Pharmacy Education and Programs
National Home Infusion Association
Jacob Deitsch, PharmD, BCPS, BCSCP, HDDP, IgCP the Director of Pharmacy Education and Programs with the National Home Infusion Association (NHIA). Deitsch has ten years of infusion pharmacy experience with six years in the home infusion industry. At NHIA, Deitsch is responsible for oversight and participation in multidisciplinary clinical education planning, development, and implementation. Deitsch holds a Doctor of Pharmacy degree from the University of Toledo and holds certifications as a BCPS, BCSCP, HDDP and IgCP.
NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Jacob Deitsch has no relevant financial relationships with ineligible companies to disclose.