$1,875 / year
Earn up to 26.5 hours of ACPE-accredited CE
Request more information about our enterprise solutions and clinical resources from TRC Healthcare.
This quality training is tailored to assist USP designated person(s) and their requirements, offering expert guidance in assessing 503B facilities, establishing an environmental monitoring program, and beyond.
Participants can complete content at their own pace over 12 months and can choose from multiple dates to attend the live sessions.
Participants will earn up to 26.5 hours of ACPE-accredited CE, including 9.5 live credits, 8 hours of on-demand webinars, and 9 hours of interactive CE. Content includes lively discussions as well as practical learning exercises that simulate real-life work scenarios.
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.
Get Best Practices on Administrative Topics. Receive best practices on establishing monitoring and sampling plans for designated persons.
Drive Pharmacy Results & Quality Control. Improve quality, compliance, and patient safety as well as receive tools to audit a sterile compounding environmental monitoring program.
Receive High-Quality Instruction. Strengthen your compounding knowledge while learning from true subject matter experts with 30 years of industry expertise.
Learn How to Choose Certifiers & Understand How to Evaluate 503B Outsourcers
- Bridge Knowledge Gaps. Build competency in this specialized field and expand your professional opportunities while receiving insight on how to effectively choose labs and certifiers.
- Improve Patient Safety. Know the latest safety, quality control, and tools to manage your compounding spaces to ensure patient safety while you receive actionable insights on USP <797> best practices and compliance.