WORKSHOP SERIES ON OCCUPATIONAL HEALTH, HYGIENE & SAFETY
ASSESSMENT AND CONTROL OF WORKER EXPOSURE
TO POTENT DRUGS & CHEMICALS
At: INDIAN INSTITUTE OF CHEMICAL TECHNOLOGY, HYDERABAD , ANDHRA PRADESH , INDIA
Wednesday, Feb. 10 – Saturday, Feb. 13, 2010
 
 
 
 
 
 
 
 
This workshop is for you, if you:
Are a Health and Safety Professional
Are responsible for health and safety for your work force and want it to be better
Want your organization to gain competitive advantage acquiring skills to implement OHS programs of international standards.
Want to network and participate in building a profession committed to “Safe Work”
Want to update or acquire OHS skills and tools for better job performance
Want to Increase your employability
  …agenda on Page 2.
 
Faculty:
Ms. Donna Heidel, CIH, is currently the Research Industrial Hygienist and Coordinator for the Prevention through Design program at NIOSH, USA. Ms. Heidel has 25 years' experience in the health care industry, spending 15 years building a world-class, global, integrated occupational toxicology and industrial hygiene program at Johnson & Johnson, a decentralized company consisting of 230 operating companies in 57 countries; implemented their global health hazard and control banding programs. Internationally, she established effective industrial hygiene processes in 32 operating companies in Europe, the Middle East and Africa and supported capital projects throughout North America, Puerto Rico, Europe, China, Singapore, Japan, and Latin and South America. Ms. Heidel is an expert in hazard and risk assessment and exposure control of highly potent compounds with extremely low occupational exposure limits, including cancer chemotherapy drugs and nanoparticles.
David M. Eherts, Ph.D., CIH, is currently the Vice President, Environmental Health and Safety, Sikorsky Aircraft Corporation. Dr. Eherts has decades of experience in the Pharmaceutical industry: He was Merck's Global Occupational and Environmental Toxicologist after which he joined Rhone-Poulenc (later merged to become sanofi-aventis) as Site Director of EHS for a 2,000-person R&D site; as global head of EHS for R&D and as Worldwide Director of Occupational Health and Industrial Hygiene; he was the Global Director of Industrial Hygiene, Environment and Product Stewardship at the company's U.S. headquarters in New Jersey. He later joined Purdue Pharma as Executive Director of EHS at its corporate headquarters in Stamford. Outside Sikorsky, Dr. Eherts heads the Return-on-EHS-Investment (ROEHSI) Taskforce for the Organization Resources Counselors (ORC) group and is a frequent presenter at design and aviation safety conferences, occupational toxicology roundtables and other industry events.
Ms. Toral Mehta, CIH is a Certified Industrial Hygienist with Masters in Industrial Hygiene from Sardar Patel University, Gujarat. She is currently the Global Project Manager at the New York office of International Safety Systems Inc.,, a global consulting firm with offices in US, India, Brazil,China and Latin America. Toral has several years experience conducting workshops on API exposure assessments, Containment Verification with Surrogate at several Multinational Pharmaceutical companies in India, USA, UK, Singapore and Canada.
Viren Shah, MIH is currently the manager of technical and Regulatory affairs at 3M, India With his extensive pharmaceutical background including position at Aventis Pharma, Viren and his team at 3M have been active in creating Industrial Hygiene and safety awareness in the industry. As a team leader he has taken up the responsibilities of product training and technical know-how of the product line. With his in depth knowledge of Pharmaceutical Process and Personal Protective equipment selection, his involvement in product design and development for the Indian market, he has been a source of excellent support to the industry and his customers guiding them in appropriate product selection. Viren along with his 3M team have been a great support to the Health and Safety professionals in the community.
And opportunity to interact with other experts
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PLEASE SHARE THE INFORMATION WITH YOUR COLLEAGUES, FRIENDS AND PEERS
Registration forms can be found at www.nayati.org
Contact nayati at services@nayati.org
Looking forward to seeing you
 
 
  Assessment and Control of Worker Exposure to Potent Drugs & Chemicals (Feb 10-13, 2010)
 
Wednesday, Feb 10, 2010
 
 
Morning Session:    
9.00am – 9.15am Registration  
9.15am – 1:30 am 11:00 am to 11.15am Coffee Break
  Introduction  
  Identification of Occupational Health Issues Associated with Active Pharmaceutical Ingredients.
Pharmacology and toxicology of active pharmaceutical ingredients (APIs), including high-potency APIs and chemical process intermediates (CPIs)
Occupational routes of exposure
Interpretation of in-silico, in-vitro and animal testing and human clinical data and application to the derivation of safe worker exposures
Occupational toxicology testing and interpretation of data
 
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1.30pm - 2.30pm Lunch 4.00pm – 4.15pm Coffee Break
Afternoon session:    
2.30pm – 5.30pm Developing Health Hazard Bands and Occupational Exposure Limits for APIs
Health Hazard Bands
 
» Default” health hazard bands for new molecular entities; Health hazard banding for investigational new drugs and APIs and CPIs with limited toxicology and/or human health data.
» Workshop #1: Developing a health hazard band for an investigational new drug
Occupational exposure limits
 
» Where to find OEL and communicate information for APIs (e.g., safety data sheets); Understanding the basis for OEL establishment, including assumptions; Developing OELs
» Workshop #2: Developing an occupational exposure limit for an API
 
 
Thursday, February 11,2010
 
Morning Session:    
9.00 am – 1.30pm 11:00am - 11.15am Coffee Break
  Qualitative Risk Assessment and Exposure Monitoring of Workers.
 
Industrial hygiene sampling and analytical methods
Development and validation of new methods: Air sampling; Surface sampling
Industrial hygiene qualitative risk assessment
  Workshop #3: Qualitative risk assessment of pharmaceutical processes
Conducting exposure monitoring surveys
Interpreting exposure monitoring results
Surrogate testing
Selection of appropriate surrogates
Interpretation of results
Workshop #4: Interpreting IH data sets
Communicating exposure monitoring results with Management; Workers; Occupational health (physicians, nurses)
   
 
 
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  Assessment and Control of Worker Exposure to Potent Drugs & Chemicals (Feb 10-13, 2010)
 
Thursday, February 11, 2010 ……….cont
 
1.30pm- 2.30pm Lunch, 4.00pm - 4.15pm Coffee Break
Afternoon Session    
2.30 pm – 5:30pm Controlling Worker Exposure Risks (A Control-Banding Approach)
 
Principles of control banding
 
» History/successes in the pharmaceutical industry; 3, 4 and 5 band models; Development of control band technology based on exposure monitoring results, published data, and/or peer data
Appropriate task-based controls/containment for bands and range of expected exposure controls
Selecting the appropriate control band based on the health hazard band/OEL and determinates of exposure
 
» Physical form; Task duration; Amount; Dilution with excipients; Process
Control band technology for low, moderate, high, to extremely high potency APIs
Workshop #5: Selecting the appropriate control band
 
Friday, Feb 12, 2010
 
Morning Session:    
9.00am – 1.30 pm 11:00 am to 11.15am Coffee Break
  Verifying controls
  Use of work practice controls and PPE to supplement engineering controls
  Workshop #6: PPE selection, donning, doffing
  Application of Prevention through Design to the Pharmaceutical Drug Discovery, Drug Development and Drug Manufacturing Process, Facilities and Equipment
1.30pm- 2.30pm Lunch, 4.00pm - 4.15pm Coffee Break
Afternoon Session    
2.30 pm – 5:30pm
Prevention through Design applied to the drug development process
 
» Laboratory, kilo lab, pilot plan, clinical supplies manufacturing and scale-up for manufacturing H&S activities to support each stage of development
Prevention through Design applied to drug synthesis and formulation processes
 
» Synthesis and formulation process considerations for high potency APIs
Prevention through Design applied to facility design and equipment selection
 
» Appropriate levels of containment and control during facility and process equipment design, specification, and commissioning
Developing effective business cases
 
Friday, Feb 13, 2010
 
Morning Session:    
9.30 am – 1.30 am 11:00am - 11.15am Coffee Break
  Questions and Open discussion
  Course Evaluation and Feed Back, Closing
1.30pm- 2.30pm Lunch
 
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