Posted by: biopharmaehsforum | May 24, 2018

BioPharma EHS Forum, 3-4 October 2018

Wednesday, October 3

1. Keynote: EHS Ties with Business Function at AbbVie – Keynote presentation; stay tuned for more details.

2. Company Site Risk Assessment Approaches – Risk assessment for the AP 39 Clinical Pilot Plant, the process which will be the subject of the Forum’s window tour on October 4.

3. ISO 45001 Standard for Occupational Safety and Health Management Systems – This recently-released and long-awaited standard is expected to have significant impact on the way companies manage their occupational safety and health programs. The discussion will be about the essential elements of the standard and interesting issues that came up during the extensive negotiations.

4. ISO 31000 Standard for Risk Management – When it rains it pours! Another recently released ISO standard that is expected to affect BioPharma companies, and all EHS professionals, is the ISO Standard 31000 for Risk Management that was recently published. It provides principles, framework and a process for managing risk. Discussion will be about the major elements of the standard and to provide recommendations to companies.

5. Safety Culture Journey – Members are always interested in hearing other company experiences on employee engagement and “operationalizing safety.” Discussion will be about the evolution of the safety culture at illumina.

6. Pharmaceuticals in the Environment – BioPharma EHS members have repeatedly requested a speaker on PiE.  BioPharma members have been polled, and we are providing the speaker with information to make the presentation most relevant to attendees: description of PiE (what is included); current regulations, high impact guidance published or upcoming, case or analytical studies or scenarios on APIs and/or metabolites, and an overview of best practices implemented by biotech/biopharma companies.

7. Future Direction/Membership of BioPharma EHS Forum – The BioPharma EHS Forum members discussed this during the September 2017 meeting at Vertex. A Vision Task Force was established to discuss the comments received during and following the meeting and to determine whether any change was needed to the purpose established in 2004, which was to provide an opportunity to senior level EHS professionals in biotech and biopharma to:
• To share ideas, best practices, network, and benchmark;
• Information exchange in a private forum;
• Continuing professional education
The Vision Task Force has had four conference calls to date and has developed and synthesized issues raised for subsequent Forum discussion. Members will receive the Task Force report (in slide format) for review and revision in early summer, and the final recommendations will be presented during the meeting for approval.

8. Human Organizational Performance (HOP) – This is a emerging area of interest for companies, and many are moving from Behavior-Based Safety to HOP, which is a leading process to minimize incidents through management engagement, critical safety rules, and other elements. Presentation will be on Allergan’s experience, which includes applying the concepts to execute programs, and statistics that correlate those programs with injury reduction. The speaker said that HOP “breaks a lot of paradigms” and stretches people, and we can expect a lively discussion.

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, October 4

1. Tour of granulation, blending operations and table press operations.

2. Measure of Training Effectiveness – BioPharma EHS Forum members have discussed challenges faced in developing, delivering and measuring the effectiveness of training programs. Speaker will talk with us on his experience and to make recommendations for improving training effectiveness.

3. Best Practices on Incident Investigation for Ergonomics/Human Factors/Human Performance – BioPharma EHS Forum members expressed interest in hearing about how other members conduct incident investigations for ergonomics events.  Experiences with TapRoot and  incident investigation using Humantech will be discussed.

4. Vivarium Ergonomics – We polled the BioPharma EHS members for specific topics, and the presentation will be based on responses. Speaker will present case studies in addressing awkward postures involved in cage cleaning, handling, opening and closing, and how to manage the administrative control of job rotation.

5. Best Practices Outsourcing Maintenance, Laboratory Services – Speaker will discuss his experiences and make recommendations for how to deal with the outsourcing of these functions.

6. Best Practices Breakout Session – The previous three topics are: Best Practices for Ergonomics Incident Investigation, Best Practices for Vivarium Ergonomics, and Best Practices for managing outsourced maintenance and laboratory operations. The meeting attendees will be divided into four or five teams; each team will take the Best Practice topic of its choice and carry it further for 25 minutes. Each team will come back to the full group to report on their findings for five-eight (5-8) minutes. This way, the meeting will end with specific and practical suggestions that attendees can implement when they return to their offices.

7. 2019 Meeting Planning – 2019 in San Diego, CA. Do we want the focus of next meeting to be biologics, pharmaceuticals or biopharmaceuticals? Planning Committee members?

Day two will adjourn at 4:30 p.m.

Posted by: biopharmaehsforum | December 15, 2017

BioPharma 2018 Meeting

Mark Your Calendars for the 2018 Meeting of the BioPharma EHS Forum on October 3-4 in Chicago. Agenda to come soon.

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.

Posted by: biopharmaehsforum | December 14, 2016

2017 BioPharma Meeting

Mark Your Calendars for the 2017 Meeting of the BioPharma EHS Forum on September 13 – 14 in Boston.  Agenda to come soon.

Posted by: biopharmaehsforum | June 14, 2016

BioPharma EHS Forum, September 14 – 15, 2016

Wednesday, September 14

  1. Keynote:
  1. Risk Communication: Why Earning Trust Equity with Stakeholders Matters – The presentation will provide case studies and recommendations for companies needing to address risk with various audiences.
  1. Federal Bureau of Investigation: Since the anthrax shipment disappearance, the FBI and its Weapons of Mass Destruction (WMD) unit, through its Coordinator of Personnel Reliability, are examining on-going threats to biosecurity.  The FBI has done significant outreach recently.
  1. Company Experiences with CDC Select Agent Program – To follow on the previous discussion, CDC has increased its focus on its Select Agent Program. A discusscussion on experiences with the program and inspections.  Other Roundtable members will be free to share their familiarity as well.
  1. Single Use Technology: Process Improvements and Waste Management– Proper handling of commonly used chemicals in bioprocessing is critical to maintaining a safe working environment, as well as operational efficiency.  Chemical mishandling can also lead to failed batch processes, quality issues, lost time and resources.  As new technologies designed to help mitigate these safety risks become available, biomanufacturers have more opportunities to ensure their production environments are safe.
  1. Roundtable on EHS Initiatives Begun, Underway, or Recently Completed– Each member will take a few minutes to discuss projects and lessons learned that may be of interest to the full group.

Day one will adjourn at 5:00 p.m.; the No Host Group dinner will begin at 6:30 p.m.; details to be provided later.

Thursday, September 15

  1. Tour
  1. Roundtable: Sustainable Practices and Lessons Learned – Water Conservation, Waste Management and Energy Conservation.   Each attendee is asked to bring three examples of practices to discuss with the group to make the discussion of most value.
  1. Antibody Drug Conjugates (ADCs): The advent of ADCs has provided a new technology platform for the treatment of various cancers and other diseases.  In theory, ADCs allow for targeted delivery of exquisitely potent materials to tumors and other diseased organs, without the concern for off-target toxicity.  This has increased the need for the proper evaluation of the hazards of these new entities in order to provide the appropriate level of protection to individuals handling these materials in R&D as well as full-scale commercial facilities.   The discussion will be on the collaboration needed among biological and chemical experts within companies to address the risks of ADCs.
  1. Contractor Safety: Trends in BioPharma Industry, Contractor Prequalification, Contractor Training and Other Issues:  An overview of trends being seen in the BioPharma Industry, processes used to prequalify contractors, evaluation metrics, and case studies/date on insurance and training.
  1. Development of Global Standards for Contractor Safety – Discussion on the need for these standards and lessons learned.
  1. Roundtable: Cleaning Chemical Usage – BioPharma EHS Forum members are interested in company experiences with cleaning chemicals.
  1. Case Studies of Three-Factor Risk Assessment and Use as Metric for “Risk Reduced” –After hearing earlier in the day about ADC and risk assessment, we will discuss this type of risk assessment and how it can be used as a metric showing risk reduced for a facility or site. Traditional risk assessment looks at likelihood of occurring vs. potential damage, while three factor risk assessment looks at frequency of exposure, damage, and controls in place.
  1. 2017 Meeting Planning – Do we want the focus of next meeting to be biologics, pharmaceuticals or biopharmaceuticals? Host volunteers?  Planning Committee members?

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

Posted by: biopharmaehsforum | February 4, 2016

BioPharma EHS Forum 2016

Please mark your calendars for the 2016 meeting of the BioPharma EHS Forum, Wednesday and Thursday, September 14 – 15, 2016 in San Diego, CA.

Agenda soon to come.

Posted by: biopharmaehsforum | March 31, 2015

BioPharma EHS Forum, September 16 – 17 2015

Here is the agenda of the recent Sep 16-17, 2015 BioPharma EHS Forum. Information about next year’s forum soon to come.

Wednesday, September 16

  1. Keynote: NIOSH Hazardous Drug Alert – New Format, Rationale for Monoclonal Antibodies Decision, State Activities – A presentation on the 2014 alert on hazardous drug exposures in health care settings.  The BioPharma EHS Forum commented during the 2007, 2009, and 2013 updates of the NIOSH “List of Antineoplastic and Other Hazardous Drugs in Heathcare Settings.”  NIOSH’s rationale for the changes made and state-level activity use of the list in regulatory settings will be of interest to attendees.
  1. Emerging Issues in BioPharma EHS, Product Stewardship –  Emerging trends in Product Stewardship and Environmental Safety and Health for BioPharma companies.
  1. Management Systems: Maximizing the Value Proposition and Lessons from the Field – Experience on management systems and their effectiveness.  The lessons learned should be particularly valuable as part of this interactive session.
  1. Management Systems: Biogen Idec’s Experience with EHS Management System 
  1. Member Panel: Lessons Learned in the Evolution of Safety Cultures – Members appreciate hearing about the experiences of their colleagues.  Different companies will share the evolution of their safety cultures.
  1. Managing Change: How to Navigate Different Company Governance Structures, Leadership Styles, and EHS Cultures – Considerable experiences with (1) how to focus on what is important; (2) how to leverage resources; (3) how to best present yourself; (4) how to meet your customer’s expectations; and (5) how change can come through many fronts.
  1. EHS Initiatives Roundtable – One person from each company will share 2015 EHS initiatives, or those underway or recently completed that may be of interest to other members.

Day one will adjourn at 5:15 p.m.; the No Host Group dinner will begin at 6:30 p.m. at the Colonial Inn after a walk around historic Concord.

Thursday, September 17

  1. 9:00 a.m. Tour – Please contact us for information.
  1. The Continuum of Enforcement: From Compliance to Criminal Enforcement – How an inspection goes from civil to criminal, from his informed perspective. Always good to hear about how to avoid criminal enforcement!
  1. Green Chemistry: Case Studies in Safety Chemistries – Case studies related to the use of safer chemistry.
  1. Member Panel: Emerging Topics in Biosafety – Emerging topics in biosafety that are of interest to members.
  1. BioPharma EHS Forum Member Sustainability Initiatives and Lessons Learned – This popular session is back, as requested by members for bi-annual discussion.  Members are invited to share their ongoing initiatives and lessons learned.
  1. 2016 Meeting Planning – Do we want the focus of next meeting to be biologics, pharmaceuticals or biopharmaceuticals? Moving back to West Coast?  Host volunteers?  Planning Committee members?

Please let me know if you have any questions.

Thank you,

Elizabeth Treanor

Phylmar Sacramento Office:  P. O. Box 660912

Sacramento, California 95866; +1.916.486.4415