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| Safety
Trainings |
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SafeBridge Consultants, Inc. offers two training courses:
(Boot Camp I) Potent Compound Safety “Boot Camp”®
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.
NEW COURSE!! (Boot Camp II) Advanced Concepts to Support Drug Development of Potent Compounds from R&D through Manufacturing
SafeBridge 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.
Course
Dates and Registration:
| Course
Dates |
Location |
Registration
Form |
Boot Camp I - Sept 28-29, 2010
Boot Camp II - Sept 30, 2010
|
Cambridge, MA
USA
|
Click Here |
Boot Camp I - Nov 2-3, 2010
Boot Camp II - Nov 4, 2010
|
Dublin, Ireland
|
Click Here |
(Boot Camp I) Potent
Compound Safety "Boot Camp"® Schedule
Day
1 |
| Time |
Topics |
| 7:45
– 8:15 |
Registration
and Coffee |
|
8:15– 8:45 |
Welcome
and Introductions |
| 8:45
- 9:45 |
Identification
of Occupational and Environmental Health Issues |
| 9:45
– 10:15 |
Elements
of a Comprehensive Pharmaceutical Occupational Health Program
and Integration into Drug Development Program |
| 10:15
– 10:30 |
Video
– Powder Handling |
| 10:30– 10:45 |
Break |
| 10:45 – 11:15 |
Group Exercise - Scenario - Part I - Crisis Response |
| 11:15
– 11:55 |
Occupational
Toxicology – Part I |
| 11:55– 12:15 |
Group
Exercise – Determining Occupational Categorization |
| 12:15
- 1:15 |
Lunch |
| 1:15 – 1:45 |
Industrial Hygiene (IH) Analytical Chemistry |
| 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
– 8:30 |
Registration
and Coffee |
|
8:30 – 9:20 |
Occupational Toxicology - Part II (OELs) |
| 9:20– 10:10 |
Group
Exercise – OEL Setting |
| 10:10– 10:30 |
Video - "Safe Handling of Potent Compounds" |
| 10:30
– 10:45 |
Break |
| 10:45
– 11:30 |
Group Exercise - IH Sampling |
| 11:30
- 12:00 |
Occupational Toxicology - Part III (ASLs and Medical |
| 12:00– 1:00 |
Lunch |
| 1:00– 1:45 |
IH Control Elements - Part II (Advanced) |
| 1:45
- 2:15 |
Environmental Toxicology |
| 2:15 – 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 |
|
(Boot Camp II) SAFEBRIDGE® ADVANCED CONCEPTS IN POTENT COMPOUND SAFETY
(BOOT CAMP II) SCHEDULE
Day 1 |
| Time |
Topics - A blend of lecture, exercises and scenarios |
| 8:00 |
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 |
|
(Boot Camp I) What You'll Learn
in The Potent Compound Safety "Boot Camp"®
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
(Boot Camp II) What You’ll Learn in Advanced Concepts to Support Drug Development of
Potent Compounds from R&D through Manufacturing: SafeBridge
Potent Compound Safety “Boot Camp II”
- 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!
Cancellation
and Substitution Policy
Your notice
of cancellation must be received in writing (by letter, fax or email)
10 working days before the training course. All cancellations will result
in a cancellation charge of 50% of the registration fee. The balance of
the registration fee will be returned if the cancellation notification
is received 10 working days in advance of the course. No refund will be
made if notification of cancellation is received beyond this time. The
registration fee minus the cancellation charge may be applied to a similar
training course if future course is held within 12 months of cancellation.
We will be pleased to transfer your registration to another member of
your company at any time. If you plan to send someone in your place, please
notify us as soon as possible.
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