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.

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