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FUNDAMENTALS OF HIGH HAZARD (POTENT) COMPOUND
SAFETY I AND II COURSE
Course Description
This 2-day, 2-part intensive course focuses on best practices, industry standards and applications of pharmaceutical high hazard (potent) compound safety principles at the pharmaceutical research and development, pilot and manufacturing scale.
Fundamentals of High Hazard (Potent) Compound Safety I covers the basic theoretical elements of high hazard (potent) compound safety including occupational toxicology, occupational exposure banding, setting of occupational exposure limits, industrial hygiene analytical methods development/sampling and exposure control methods and program development.
Fundamentals of High Hazard (Potent) Safety II covers the practical application of the elements and concepts outlined in Fundamentals of High Hazard (Potent) Safety I including primary and secondary containment technologies, isolation technologies including glove box isolators, single pot processors, A/B and Split Butterfly valves, integrated solids processing systems and containment verification and testing. In addition, overall design considerations including architectural, mechanical and dedicated facilities are addressed. Finally, case studies of actual designs and installations will be reviewed.
Who Should Attend
Because of its comprehensive content, these courses will be valuable to personnel in research and development, environmental, health & safety, engineering, facilities management, regulatory affairs, manufacturing, quality assurance, project management and the quality control laboratory that are involved and handle potent compounds. This includes those whose job responsibilities involve direct involvement with product development, facility design and manufacturing as well as those individuals whose job responsibilities entails an awareness and knowledge of the impact of handling potent compounds including marketing, project management and outsourcing. To obtain the full benefit of the course, it is highly recommended that individuals attend both days, however for those individuals who have experience working with high hazard (potent) compounds, have attended other seminars or wish to obtain up-to-date information, attendance for only Fundamentals of High Hazard (Potent) Compound Safety II is allowable.
Course Objectives
Upon completion of Fundamentals of High Hazard (Potent) Safety I, you will:
- Understand basic occupational toxicology terminology and concepts,
- Be familiar with performance based exposure control banding (PBECL) concepts,
- Understand industrial hygiene sampling and analytical method requirements and concepts.
Upon completion of Fundamentals of High Hazard (Potent) Safety II you will:
- Understand primary and secondary facility design concepts,
- Be familiar with various equipment containment, isolation and enclosures for exposure control,
- Know how to evaluate containment and isolation device effectiveness.
Both courses are limited to number of participants. Our small class size ensures that you receive individual attention from our highly skilled Course Instructors. Cancellation after the set deadline will result in a 25% penalty of the registration fee (for administrative costs) and return of the balance of the training registration fee. Your cancellation must be received in writing (by e-mail or fax). Substitutions are permitted with notification prior to the start of the course.
2.0 Industrial Hygiene ABIH Certification Maintenance Points -
Approval #06-2800
For Complete Course and Registration Information please visit the links below
Course Outline_NJ-09_
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