Posted by: biopharmaehsforum | August 28, 2017

BioPharma EHS Forum, 13-14 September 2017

Wednesday, September 13

1. Keynote: EHS ties with the business function based on experiences in the executive suite – Will also describe impacts of EHS on the company over time.

2. National Fire Protection Association’s Industrial and Chemical Division – NFPA’s recent work, trainings they present, and how the NFPA writes, reviews, updates and revises its consensus standards.

3. EPA Enforcement Continuum: From Compliance to Criminal Prosecution – The continuum and the potential liability for EHS staff. The speaker will speak from his informed perspective on how an inspection goes from civil to criminal. Always good to hear about how to avoid criminal enforcement!

4. Company Experiences with Auditing Third Party Suppliers – BioPharma EHS members are interested in hearing about this topic, based on meeting evaluation comments. A panel will discuss their company auditing approach for 3rd party suppliers: waste vendors; managing acquisitions/ divestitures; contract manufacturing, pharmaceutical supply chain initiative. Each speaker will discuss their company’s approach, challenges, and lessons learned.

5. Industrial Hygiene Case Study: Paracetic Acid – A discussion of the use and monitoring of sterilizing agent (peracetic acid) exposures from cleaning operations and lessons learned will be provided.

6. Managing the Industrial Hygiene Program at GSK – GSK has launched a comprehensive industrial hygiene chemical agents risk management strategy (OH ChARM) which has enabled a clear picture of risk, competency, controls and continuous improvement in the chemical agent space across 70+ manufacturing sites.

7. Biogen’s Sustainability Journey – Biogen’s company experience and lessons learned as their program evolved.

Day one will adjourn at 5:15 p.m.; the No Host Group dinner will begin at 6:30 p.m.; details to be provided later.

Thursday, September 14

1. Mission/Vision for BioPharma EHS Forum – Attendees are invited to a working breakfast to discuss current member ideas about the future of the Forum, which was established in 2004 for senior level EHS professionals in biotech and biopharma to benchmark, share best practices, network, and exchange information in a private forum. Opportunities for continuing professional education are also provided. It seems appropriate to review the goals of the group, as membership has changed and perhaps priorities have changed as well.

2. Vertex Final Tablet Formulation Manufacturing – Overview of the operations – a one of a kind machine that validates in real time as the tablet is made. The machine takes the powder, blends it, takes all sorts of measurements to validate; output is total tablet. This machine is the first of its kind to be approved by the FDA.

3. Panel on Lessons Learned from Developing and Implementing EHS Information Reporting Systems – Each member will take a few minutes to discuss lessons learned that may be of interest to the full group. Discussion regarding experiences with CR 360, using the ULPURE Platform. EMD-Millipore worked with UL to develop the system which is maintained externally. Discussion of the need, how it works, and lessons learned in implementation. Lessons learned from an IH trying to pilot and implement IT systems within a corporate structure. How to plan for requirements and time commitments.

4. Sustainability in the Workplace: A New Approach for Advancing Worker Safety and Health – White paper about the importance of including worker safety and health in the push toward sustainability and corporate responsibility.

5. Containment and Control: Why Procedures Matter – Importance of clear, consistent and understood procedures. The Biopharma industry commits resources towards purchase and installation of control and containment systems including ventilated balance enclosures, chemical hoods, isolators, flexible containment, and custom units. Resources are also invested in facility design features such as once through air, gowning and degowning facilities, and room pressurization. With all of these controls in place, procedures are key to the proper operation of facilities and equipment. Data has been gathered to demonstrate key procedures that are critical to safe handling of potent compounds within the control and containment equipment. This presentation focuses on those procedures and provides data to back up the importance of the proper techniques.

6. Experiences with Workplace Violence Prevention Programs – Discussion on their journey implementing a workplace violence prevention program.

7. Leading Indicators and Correlation to Results – Providing information on member experiences.

8. Sharing Significant EHS Events – An idea to share lessons learned from incidents in a more structured way.

9. 2018 Meeting Planning – Do we want the focus of next meeting to be biologics, pharmaceuticals or biopharmaceuticals? Moving back to CA? Host volunteers? Planning Committee members?

Day two will adjourn at 5:15 p.m.



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