Designated Person Administrative Best Practices

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. 

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.