Participants will gain a comprehensive understanding of environmental control requirements within the cleanroom suite and learn how to select the proper materials and cleaning agents to maintain a controlled environment. The course will also address best practices for investigating and remediating environmental excursions, ensuring that issues are resolved effectively and sustainably. Through structured guidance and practical application, learners will strengthen their ability to oversee competency processes with confidence. By the conclusion of the session, attendees will be prepared to uphold the rigorous standards essential to safe, compliant, and high-quality sterile compounding.

Learning Objectives:

1. Describe the specific environmental control requirements in the cleanroom suite.
2. Select appropriate materials and cleaning agents for use in the cleanroom suite.
3. Demonstrate correct hand hygiene, garbing, and material/personnel movement techniques to minimize contamination risk.
4. Investigate environmental monitoring excursions, determine root causes, and implement/document effective corrective and preventative actions.

NHIA General CE Information

The session will focus on the critical role the designated person plays in ensuring that Standard Operating Procedures (SOPs) are both appropriate and effectively implemented within sterile compounding environments. Participants will explore the importance of reviewing SOPs upon development and at least annually to confirm alignment with current practices. The session will also emphasize best practices for documenting revisions and communicating changes to all affected personnel. By the conclusion, learners will have a clear understanding of their responsibilities in managing and maintaining SOPs to promote safety, compliance, and excellence in sterile compounding operations.

Learning Objectives:

1. Specify when an SOP is required accorrding to USP <797>.
2. Describe how the designated person is involved in SOP development and oversight.
3. Develop examples of SOPs that are effective and meet regulatory requirements. 
4. Established processes to review SOPs to ensure they reflect current practices and regulatory requirements. 

Participants will explore the roles of key regulatory agencies and healthcare accreditation organizations involved in pharmacy inspections and survey visits. The course will provide practical guidance on appointing a designated person, preparing staff for inspections, and responding effectively to deficiencies cited in inspection reports. By the end of the session, attendees will have a clear understanding of how to establish and manage competency processes that ensure compliance with USP <797> standards and support excellence in sterile compounding practice.

Learning Objectives:

1. Describe the regulatory agencies and accreditation organizations that conduct inspections and surveys.
2. Explain the role a designated person plays in preparing staff for inspection day.
3. Identify who should draft and submit the official response to deficiencies cited in inspection reports.
4. Develop a practical inspection-readiness plan to sustain continuous compliance. 

NHIA General CE Information

Participants will learn how to review and interpret cleanroom certification reports to verify compliance with USP <797> standards. Key topics include identifying and evaluating critical report data, documenting personnel presence during testing, and confirming certifier training and competency. The course will also emphasize the importance of signing off on certification reports and ensuring all requirements are met. By the conclusion, attendees will be equipped with the knowledge and skills needed to confidently oversee cleanroom certification processes and maintain compliance in sterile compounding operations.

Learning Objective:

1. Describe the responsibilities of the designated person, including the need to sign off on the report. 
2. Ensure certification records for the cleanroom suite meets the requirements of USP <797>.
3. Identify where to find and interpret information included on a certification report.
4. Utilize a checklist or structured tool to consistently document, verify, and sign off on certification reports.

NHIA General CE Information

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:

1. Identify key USP <797> documentation requirements for compounded sterile preparations.
2. Apply proper techniques for correcting documentation errors while maintaining traceability.
3. Design compliant systems for document retention, retrieval, and accessibility.
4. Document staff competencies, training, and qualifications accurately and completely.

NHIA General CE Information

Participants will learn to clearly differentiate between training and competency, recognizing the unique role each plays in sterile compounding practices. The course will emphasize critical thinking in the design and management of competency processes that align with organizational needs. Attendees will also examine the importance of regularly updating content and procedures to remain compliant with evolving standards. By the end of the session, learners will be equipped to sustain high levels of sterility assurance and process reliability within their facilities.

Learning Objectives:

1. Understand the fundamental differences between training processes and competency assessment in sterile compounding environments.
2. Learn and implement critical thinking skills necessary to create and manage effective processes for sterile compounding competencies.
3. Recognize the importance of frequent content and process updates to maintain compliance and ensure patient safety.
4. Communicate standard operating procedure (SOP) changes, and document everything clearly and transparently.

NHIA General CE Information