Safebridge

AIHA Laboratory Accreditation Program

Advanced Concepts in Potent Compound Safety (Boot Camp II)

A one-day advanced course with a focus on case studies and problem-solving to address potent compound safety issues in discovery, development, contract manufacturing and commercialization utilizing the “systematic” approach and the implementation of a comprehensive program required to successfully support drug R&D and manufacturing organizations.

A suggested pre-requisite for the Advanced Concepts course is previous attendance at SafeBridge Potent Compound Safety “Boot Camp”® (Boot Camp I) and/or significant experience in environmental health and safety applications in the pharmaceutical industry. You may register for one or both courses.

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 Gail Baer at gail.baer@safebridge.com FIRST to reserve a space. 

Course Schedule

Day 1
Time Topics - A blend of lecture, exercises and scenarios
8:15 Introduction
Overview of drug development process
8:30 Drug Discovery
Drug discovery involves the creation of new chemical entities (NCEs) and new biological entities (NBEs) at the laboratory bench. NCEs and NBEs are handled in milligram to gram quantities with researchers working very close to their materials in work environments typified by standard control devices (lab hoods, biological safety cabinets) and limited personal protective equipment (lab coats, gloves, safety glasses).

This module will examine:
  • Evaluation of compounds based on the literature, experience, computer modeling and early testing;
  • Identification of the unique risks of the research laboratory; and
  • Selection and verification of effective control strategies.
 
10:15 Break
10:30 Drug Development –Early Stages
NCEs and NBEs showing promise begin to be scaled up in kilo laboratories and drug product work begins in pre-formulation laboratories and formulation development suites. Pre-clinical data becomes available and small safety studies are initiated including Phase I safety and efficacy studies. Research and development staff may now be working with multi-gram and kilogram quantities of materials. It can be common that exposure controls are not much more advanced than those found in the discovery labs. Real risk management challenges are possible if the drugs are pharmacologically potent and toxic at levels found in these work environments.

This module will examine:
  • Evaluation of toxicity and clinical data;
  • Evaluation of worker exposure at increasing scales of operation;
  • Enhanced controls; and
  • Development and effective use of IH data.
 
12:15 Lunch
1:00 Drug Development – Late Stages
As drugs successfully move beyond basic demonstration of safety and efficacy in patient populations, broader studies are initiated requiring more drug substance and drug products manufactured in cGMP environments. Chemical pilot plants, clinical manufacturing suites and support laboratories are utilized at this stage. Small companies will engage contract manufacturing organizations (CMOs) and project management takes on increased importance. More pharmacology and toxicology data will become available which require prudent interpretation and utilization to assess potential workplace risk. Operations become more varied and control options are more numerous; however, the occupational health concerns have to be balanced with the requirements for product quality for the clinical materials manufactured. Preparations also begin for larger scale manufacturing including potential site selection in Phase III.

This module will examine:
  • Evaluation of more complex data;
  • Application to quantitative risk assessment; and
  • Implementation and demonstration of effective controls at larger scales.
 
2:30 Break
2:45 Commercial Scale Operations
Sufficient data exist at the time of a New Drug Application to develop all the assessment tools required for scientific determination of safe operations including OELs, ASLs, ADIs and monitoring methods. Additionally the environmental aspects of a drug reaching this stage should have been studied and requirements for Environmental Assessments should have been met. CMOs should have been appropriately selected and in place as necessary along with any internal manufacturing sites. All control options are available in these manufacturing environments and selection of the best approaches must be balanced with productivity requirements.

This module will examine:
  • Application of defensible limits;
  • Evaluation of CMOs; and
  • The concept of product safe handling guidelines.
 
4:30 Wrap Up

What You’ll Learn

  • Data availability at each stage of the drug development process
  • Containment and control, and handling guidelines for potent compounds at each scale of operation
  • Problem solving using case studies in R&D and manufacturing of potent compounds
  • Reviewing data obtained from occupational, non-clinical and clinical studies and industrial hygiene surveys and interpreting their applicability to case studies
  • Potent compound safety issues with outsourcing as a paradigm for R&D and manufacturing of potent APIs and products
  • And much more!