Safebridge

AIHA Laboratory Accreditation Program

Potent Compound Safety “Boot Camp”® (Boot Camp I)

A comprehensive two-day course in pharmaceutical potent compound safety with a focus on training EH&S and related professionals in critical technical concepts and proactive safety programs in the pharmaceutical, chemical and biotechnology industries.

Course Dates and Registration

Course Dates Location Registration Form

Boot Camp I - November 14-15 2017
Boot Camp II - November 16, 2017

New Brunswick, NJ

 Coming Soon

Registration Fees:

Boot Camp I $2375 for the first attendee, and
$2175 for each additional attendee for the same course from the same company
Advanced Boot Camp II $1225 for the first attendee, and
$1175 for each additional attendee for the same course from the same company
Both Courses $3375 for the first attendee, and
$3075 for each additional attendee from the same company

The above cost includes Course Syllabus, meals,(breakfast, lunch and afternoon breaks) and Certificate of Completion. Payments may be made by check, invoice, Visa, MasterCard or American Express.

SEATING IS LIMITED AND OUR COURSES USUALLY SELL OUT! Therefore, we ask that you call or email Catherine Connor at catherine.connor@safebridge.com FIRST to reserve a space

Course Schedule

Day 1
Time Topics
7:45 – 8:15 Registration and Coffee
8:15 – 8:30 Welcome and Introductions
8:30 – 9:30 Identification of Occupational and Environmental Health Issues
9:30 – 10:00 Elements of a Comprehensive Pharmaceutical Occupational Health Program and Integration into Drug Development Program
10:00 – 10:15 Break
10:15 – 10:30 Video – Powder Handling
10:30 – 11:00 Group Exercise - Scenario - Part I - Crisis Response
11:00 – 11:45 Occupational Toxicology – Part I
11:45 – 12:15 Industrial Hygiene (IH) Analytical Chemistry
12:15 – 1:15 Lunch
1:15 – 1:45 Group Exercise – Determining Occupational Categorization
1:45 – 2:35 IH Sampling
2:35 – 3:00 Video - "Working Safely with Pharmaceutical Chemicals" and "Modern Pharmaceutical Manufacturing"
3:00 – 3:15 Break
3:15 – 4:10 IH Exposure Controls - Part I (Traditional)
4:10 – 4:30 Group Exercise - Scenario Part II - Crisis Management
4:30 – 4:45 Summary of Day 1
Day 2
Time Topics
8:00 – 8:15 Registration and Coffee
8:15 – 9:00 Occupational Toxicology - Part II (OELs)
9:00 – 9:50 Group Exercise – OEL Setting
9:50 – 10:15 Video - "Safe Handling of Potent Compounds"
10:15 – 10:30 Break
10:30 – 11:30 IH Control Elements - Part II (Advanced)
11:30 – 12:00 Occupational Toxicology - Part III (ASLs and Medical
12:00 – 1:00 Lunch
1:00 – 2:00 Group Exercise - IH Sampling
2:00 – 2:30 Environmental Toxicology
2:30 – 3:00 Risk Communication
3:00 – 3:15 Break
3:15 – 4:00 Group Exercise - Scenario - Part III - Risk Communication
4:00 – 4:20 Process Hazard Review, Program Management and Summary
4:20 – 4:45 Post-test and Evaluation

What You'll Learn

Introduction and Identification of Occupational and Environmental Health Issues

  • Potential of pharmaceutical substances to cause occupational illness
  • Case Studies
  • Regulatory Requirements

Overview of Comprehensive Pharmaceutical Occupational Health

  • Program Elements
  • Integration of EH&S Elements Into Drug Development Templates

Occupational Toxicology

  • Definition of "potent compounds"
  • Compound Categorization and Handling Practices System (Control Banding)
  • Setting Occupational Exposure Limits (OELs)
  • Setting health-based acceptable surface limits (ASLs)
  • Medical Surveillance

Industrial Hygiene Analytical Chemistry

  • Sampling and Analytical Methods Development
  • Setting Analytical Targets
  • Method Validation
  • Surface Sampling Method Validation
  • Sample Submission and Analysis

IH Sampling

  • Developing a sampling strategy
  • Techniques for potent compound air monitoring
  • Techniques for potent compound surface monitoring

IH Control Elements

  • Factors Leading to Potential Exposures
  • Engineering Controls and Containment
  • Administrative Controls and Procedures
  • Personal Protective Equipment
  • Facility Design Elements

Environmental Toxicology

  • Fate and Effects Determination
  • Potential of pharmaceutical substances to cause environmental impairment
  • Cleaning and Waste Disposal Options
  • Regulatory Requirements (in U.S., Canada and abroad)
  • Impact on Drug Approvals

Process Hazard Review Techniques

  • Concepts
  • Gathering appropriate information
  • Design development stage
  • Pre start-up and Post Operational Review

Program Management and Summary

  • Incident Investigation and Risk Communication
  • Summary

Exercises