Nonhazardous Sterile Compounding + Designated Person Administrative Best Practices

History of Sterile Compounding (1 hr ACPE credit) 

Learn about the evolution of pharmacy compounding and the development of national standards of practice. 

Determining USP 797 Beyond-Use Dating (1 hr ACPE credit) 

Review USP requirements around beyond-use dating (BUD) and recognize the risk of microbiological contamination in compounded sterile products. 

Quality Releases and Final Checks for Sterile Compounding (1 hr ACPE credit) 

Learn about the requirements set out by USP 797 for release inspections and testing, including visual inspection, sterility testing, and bacterial endotoxins testing. 

USP 797 CSP Handling: Staging through Transport (1 hr ACPE credit) 

Consider unique factors when advancing a CSP from staging to transport, including numerous opportunities where mistakes can be made, and how robust procedures can help prevent errors. 

Master Formulation and Compounding Records for Sterile Compounding (1 hr ACPE credit) 

Use compounding documentation to provide evidence of procedures or activities performed during compounding, such as compounding instructions, equipment required, and calculations. 

Standard Operating Procedures for Sterile Compounding (1 hr ACPE credit) 

Recognize the importance of standard operating procedures (SOPs) to ensure the preparation of medication is reproducible and reduce preventable errors and patient injuries. 

General Elements of Documentation for Sterile Compounding (1 hr ACPE credit) 

Review key elements of good documentation, including USP 797 requirements, and why it’s important to maintain good documentation at your compounding facility. 

Use of Equipment and Integrating Technology for Sterile Compounding (1 hr ACPE credit) 

Recognize how to utilize automated compounding devices (ACDs) for sterile compounding and the techniques and work practices that must be implemented to minimize microbiological contamination of compounded sterile preparations. 

Overview of Environmental Monitoring (1 hr ACPE credit) 

Learn about essential components of an environmental monitoring program, including processes for viable air and surface sampling. 

Viable Air and Surface Sampling (1 hr ACPE credit) 

Review viable air and surface sampling and the correct sequence for these as part of an overall engineering monitoring program. 

Investigation and Remediation of Viable Environmental Monitoring and Personnel Sampling Excursions (2 hr ACPE credit) 

Learn about common microorganisms in sterile compounding environments and how to investigate, document, and remediate a microbial excursion. 

Insanitary Conditions (1 hr ACPE credit) 

Review insanitary conditions and the differences between 503A and 503B. 

What Are cGMPs? (1 hr ACPE credit) 

Learn about the history of Current Good Manufacturing Practices and how this applies to 503A and 503B entities.

Review of FDA 503B Draft and Final Guidance (2 hr ACPE credit) 

Review expectations of a 503B outsourcer. 

Aseptic Technique and Conduct for Sterile Compounding (1 hr ACPE credit) 

Review the concept of performing aseptic compounding in a disciplined and consistent fashion to safeguard patients from preventable disease and injury related to contaminated compounded sterile preparations. 

Sterile Compounding Contamination Control Principles (0.75 hr ACPE credit) 

Achieve a practical understanding of the importance of contamination control principles and how workflow activity challenges the microbial state of control in sterile compounding environments. 

Sterile-to-Sterile Compounding (1.25 hr ACPE credit) 

Gain knowledge about newly required components of sterile compounding practices, including beyond-use dating, drug testing, and stability and quality release testing. 

Sterile Compounding Documentation (0.5 hr ACPE credit) 

Learn about the importance of documentation and the required components of successfully documenting compounding processes. 

Secondary Engineering Controls for Nonhazardous Sterile Compounding (1.5 hr ACPE credit) 

Learn the minimum USP chapter requirements for engineering controls and distinguish best practices for facility-specific designs that achieve operational compliance rather than just meeting regulatory compliance. 

Hand Hygiene and Garbing for Sterile Compounding (1 hr ACPE credit) 

Review key elements of effective hand hygiene and garbing as required by USP 797. 

USP 797 Material Handling (0.5 hr ACPE credit) 

Explore elements of contamination control that emphasize the movement of supplies and materials into controlled areas. 

USP 797 Personnel Sampling (1.25 hr ACPE credit) 

Examine the expanded compliance requirements now outlined in USP 797, including documentation, competency evaluation, and the development of a personnel sampling program as determined by the designated person. 

Primary Engineering Controls for Nonhazardous Sterile Compounding (1 hr ACPE credit) 

Receive a practical understanding of primary engineering controls (PECs), how they function by design, and how we must operate within the inherent limitations all PECs have in sterile compounding facilities. 

Aseptic Work Practices Overview for Sterile Compounding (0.75 hr ACPE credit) 

Learn about critical elements of aseptic work practices to use in sterile compounding. 

Testing and Certification of PECs and SECs (USP 797) (1.25 hr ACPE credit) 

Increase your confidence when engaging in conversations with certifiers regarding certification testing and documentation. Learn required and best practice elements of reporting to ensure quality and USP chapter compliance. 

Sterility and Bacterial Endotoxin Testing Specific to USP 797 (0.75 hr ACPE credit) 

Acquire a deeper understanding of USP 71 and elements of sterility testing, rapid microbial testing (RMT), and bacterial endotoxin testing (BET). 

Sanitization of Sterile Compounding PECs and SECs (1.25 hr ACPE credit) 

Learn more about how daily and monthly cleaning along with ongoing sanitization processes works to ensure the safety of the compounding environment. 

Environmental Monitoring (1 hr ACPE credit) 

Review key requirements of an environmental monitoring program and how to perform a proper investigation and remediation process in the event of an exceeded action level. 

Quality Systems for Sterile Compounding (1 hr ACPE credit) 

Learn more about the development and implementation of a sterile compounding quality assurance (QA) and quality control (QC) program. 

Critical Elements of Aseptic Technique (1.5 hr ACPE credit) Review operator conduct, disinfecting and sanitization, and other concepts that make up the critical elements of aseptic technique. 

Qualification of Vendors and Products (0.5 hr ACPE credit) 

Gain insight on common industry practices used to qualify vendors and products that help maintain regulatory compliance. 

Inspecting 503B Outsourcing Facilities (1 hr ACPE credit) 

Review key elements of inspecting 503B outsourcing facilities. 

Choosing a Laboratory (USP 797) (0.5 hr ACPE credit) 

Learn specific regulatory features and quality characteristics when choosing a suitable laboratory vendor. 

Creating an Effective and Compliant Environmental Monitoring Program (USP 797) (0.75 hr ACPE credit) 

Learn about critical aspects of creating a robust, effective environmental monitoring program. 

Developing a Sampling Plan (USP 797) (0.75 hr ACPE credit) 

Master the steps of sampling plan development while considering locations that pose the greatest risk to the CSP. 

Investigation and Remediation (USP 797) (1 hr ACPE credit) 

Explore investigation and remediation strategies and how they support a successful environmental monitoring program. 

Trending Environmental Monitoring Data (1 hr ACPE credit) 

Discover the importance of trending and how the data benefit the overall EM program. 

Review of Certification Reports and Smoke Pattern Testing (1 hr ACPE credit) 

Learn the best practice elements of certification reporting and basic USP requirements for airflow smoke pattern testing. 

Best Work Practices & Identifying Insanitary Conditions (3 hr live, ACPE credit) 

Learn about elements that make up best work practices and how to identify insanitary conditions within a sterile compounding area. 

Decoding FDA Forms and Warning Letters (1.5 hr live, ACPE credit) 

Become familiar with FDA forms and warning letters, including areas of focus and appropriate responses. 

All About Sampling (3 hr live, ACPE credit) 

Learn about sampling requirements, including best practices for collecting and reading samples. 

Facility Design and Certification (2 hr live, ACPE credit) 

Review requirements for sterile compounding areas and learn about certifications that are needed.