In addition to our popular flagship program, the Sterile Compounding Boot Camp™ (a 2.5 day program that provides a comprehensive overview of sterile compounding requirements and best practices) CriticalPoint is pleased to announce additional live training classes that provide opportunities for a deeper dive into specific compounding topics requested by our customers. These courses will be offered in our Center for Training and Research in Totowa, NJ which houses two 797 compliant ISO Class 7 buffer rooms, ISO Class 8 anteroom, Containment Segregated Compounding Area and state of the art classroom.

We would like to hear from you on your level of interest for each of these classes and understand more about your preferences on the length and scheduling of training.

We thank you in advance for your time!

Sincerely,
The CriticalPoint Team


Please tell us your degree of interest in the courses below.

Question Title

* Best Practices for Hazardous Drug Handling, Compounding and Administration

Appropriate for medical, nursing and pharmacy workers, this class will review current and proposed regulation with regard to all aspects of handling hazardous drugs (HDs) that will allow users to future-proof their facility and employ best work practices when performing both non-sterile and sterile HDs. An opportunity to practice negative pressure sterile compounding as well as CSTD use will be made available.

Question Title

* Best Practices for Development and Implementation of Sanitization Programs for Pharmacy Controlled Environments

Appropriate for all staff involved in designing, performing and overseeing the cleaning and disinfection of pharmacy controlled sterile compounding environments. Theoretical underpinnings as well as practical workplace tips will be shared along with an opportunity to perform cleaning and disinfection in a variety of primary and secondary engineering controls located at our facility.

Question Title

* Using Pharmaceutical Microbiology to Design and Implement Meaningful Environmental Sampling Programs

This program is intended for individuals who design and implement environmental sampling programs for pharmacy sterile compounding facilities and 503B operations. Principles of microbiology that are relevant to cleanrooms will be presented and will build a foundation for a detailed discussion of actual personnel and facility related viable sampling. Participants will have an opportunity to create and critique an environmental sampling plan for their own facility and perform actual sampling in our state-of-the-art 797 compliant sterile compounding complex.

Question Title

* Evaluating Competency and Promoting Proficiency in Sterile Compounding

This class provides a deep dive into requirements and best practices that will ensure competency and promote proficiency of staff which is the cornerstone to building quality into compounded sterile preparations. Alternatives to the traditional behavioral checklist approaches will be presented and successful case studies discussed.

Question Title

* Planning for a Compliant Cleanroom Renovation or Build: Meeting the Requirements and Avoiding the Pitfalls

Intended for pharmacists, technicians, engineers, cleanroom designers and others who have direct or indirect responsibility and decision-making authority with regard to evaluation of cleanroom renovations, retrofits and builds. The information in this class will help to avoid common mistakes that end up costing money later and result in regulatory fines and citations. Taught by James T. Wagner and Eric S. Kastango who have been involved with, supervised and visited hundreds of sterile compounding facilities.

Question Title

* Aseptic Training for Sterile Compounding

This two day class is intended for anyone who is entering the sterile compounding field or who has not received formal aseptic technique training. This curriculum includes concepts related to the use of primary and secondary engineering controls; hand hygiene and garbing, particle generation during operations; use of first air; aseptic manipulations and personnel sampling. Participants will perform actual aseptic manipulations in our fully compliant primary and secondary engineering controls and will undergo initial gloved fingertip sampling as well as media fill testing with integrated glove fingertip sampling and surface sampling. Results of sampling will be sent to each participant at the conclusion of the incubation period.

Question Title

* Aseptic Training Refresher

This one day class is intended as a refresher for those actively compounding and are already familiar with hand hygiene, garbing, material handling and aseptic manipulations. Didactic material reviewing concepts of aseptic technique will be followed by a practicum in which proficiency in hand hygiene and garbing and aseptic technique are confirmed and objective personnel sampling performed.

Question Title

* Best Practices in Non Sterile Compounding

This class will review current regulation and best practices standards as they relate to non-sterile compounding and is intended as an overview of non-sterile practices. Interactive lectures will cover appropriate primary engineering controls, facility requirements, hand hygiene and PPE, work practices, competency approaches and documentation. Drug strength testing and other lagging indicators will be discussed in depth.

Question Title

* Sterile Compounding Quality Management Systems: What are they and how can I set them up in my facility?

USP Chapter <797> states that a “provider of CSPs shall have in place a formal QA program intended to provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes described in this chapter. Emphasis in the QA program is placed on maintaining and improving the quality of systems and the provision of patient care.” This class provides concrete guidance about how to do that in your facility from a faculty who has demonstrated proficiency and success in this area.

Question Title

* High Risk Compounding

This class is intended for those who are performing non-sterile to sterile compounding or who are considering adding this to their operation. Those who attend this class must be advanced practitioners who have already demonstrated proficiency with regard to sterile to sterile compounding practices. Discussion and lab exercises will focus on best practices with regard to hand hygiene and garbing; selection, validation and limitations of sterilization methods; sterility testing and potential alternative methods.

Question Title

* Want to Outsource Some or All of Your Pharmacy’s Cleaning? Here’s what you need to Know

This class is intended for pharmacy managers and staff before they outsource cleaning duties. It is also appropriate for those entities delivering this service to sterile compounding pharmacies. Requirements and best practice considerations on hand hygiene and garbing and cleaning in controlled environments that perform both non hazardous compounding as well as those that compound hazardous drugs. Selection and proper application of cleaning agents; frequencies, special considerations, documentation, training and competency requirements are discussed.

Question Title

* Considering 503B Registration? Take this Class Before you Move Forward

This class is intended as an indoctrination into the current good manufacturing practices (CGMPs) which must be internalized, integrated and followed in 503B operations. Central to the concept of the CGMPs is the constant drive to remove variability from processes since without consistency quality cannot be achieved. Faculty that teach this course have experience in reengineering pharmacy practice models that resulted in the type of quality culture expected by the Federal Food and Drug Administration. In order to move from a pharmacy model to a manufacturing model sweeping changes must be made not only to procedures but to the fundamental organizational culture. These expectations and their inherent difficulty to achieve must be well understood before moving forward with registration.

Question Title

* Are there any additional courses that you would be interested in?

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