Biopharma EHS

Biopharma EHS

By Affygility Solutions, LLCNewsBusiness News
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Biopharma EHS episodes

  • Biopharma EHS Podcast Episode #9

    Biopharma EHS Podcast Episode #9

    Opening

    So for today, first off, I'll mention what we discussed last time, then we I'll cover our main topic for today - which is how to be a road warrior of environmental, health and safety, and then finally, I will mention important upcomings and happenings that are applicable to environmental, health and safety professionals in the Biopharma industry.

    So, in our last podcast, episode 8, I discussed the future of EH&S. Now, when I'm talking about the future, I'm not talking what's on OSHA's regulatory agenda for this year or next, I'm talking about 15 to 20 years ahead. In that episode, the key issues and technologies that I personally forecasted and will impact environmental, health and safety professionals include the untethering of the workplace, the widespread use of mobile phone applications for environmental, health and safety, industrial hygiene, environmental compliance and more; managing environmental, health and safety in crowdsourcing; just-in-time EHS training; conferences becoming much more social; and finally "occupational toxicology on a chip". If any of this interests you, I would strongly suggest that you go back and listen to the entire episode.

    Let's now go ahead and move on to the next topic, and get started with how to be an effective road warrior of environmental, health and safety?

    So what exactly is a Road Warrior? Well, a road warrior is typically, is typically, thought of as a person that travels frequently on business. So far, in my lifetime, I've seen environmental, health and safety professionals that traveled anywhere from once a quarter to provide environmental, health and safety compliance support to facilities under their control, to those that left home on Sunday afternoon and didn't returned home till Friday evening. These EH&S professionals included internal auditors, contract manufacturing auditors, consultants, and EH&S managers that were responsible for managing multiple facilities throughout the world. On the extreme end of things there are some professionals that travel 250,000 air miles per year. To put that in perspective, that's approximately one roundtrip flight from Denver to India per month.

    So if you're a Road Warrior of EH&S, how do you make the best out of this situation where you are always gone away from the office?

    First off, being an effective EHS Road Warrior starts well before you think about going to the airport and requires careful planning. When you travel a lot you need to develop a routine. To the extent possible, try to schedule your trips at the same time every month and then block them out on your calendar. Plan trips carefully and at least two months ahead. Make sure you have a way to compare your business calendar with your personal calendar. After all you don't want to schedule a trip and then realize that it's conflicts with important life events.

    Next, you will also want to get the right kind of luggage, the right kind of laptop computer case, and other travel accessories. Look for luggage with lots of outside pockets to stash away all your gear. True Road Warriors hardly ever check luggage. It's just not worth the delay waiting to check/pickup your bags, and the risk of having your luggage lost. You may also want to arm yourself with a really good set of headphones. I personally use a set of Bose noise-cancelation headphones and they are great the next time you have a screaming baby sitting next to you.

    If you drive your own car to the airport, try to always park in the same general area. This will reduce the chance that you will forget where you park your car. This is especially true when you start having back-to-back trips. If you can't always park in the same place take a picture of the parking lot location sign with your smartphone's digital camera.

    When traveling frequently to the same location, whether as a routine visit or for a project, try need to find a good hotel that you like and make a habit of staying there. You want it to feel like home. And, if you check into a hotel and walk into the room and it's crap, don't be shy and afraid to go to the front desk and say "I'm going elsewhere." I remember many years ago I had to perform some emergency response training in the middle of nowhere in Georgia. I got to my hotel and there where roaches running across the floor and the toilet was all yellow urine stained. I didn't last 3 minutes till I went to the front desk and said bye. This doesn't mean you have to be a jerk, it just means you need to have personal standards and try to maintain them while traveling. The typical things I look for when selecting a hotel: first off, it needs to be close to the facility that I'm visiting. I hate, I absolutely hate, having to wake up super early just to fight traffic to get to the facility, 2) it better have a decent in-hotel workout facility. If you're traveling frequently it is extremely important that you maintain an exercise routine - otherwise, airplane and airport food will cause your health to decline rapidly and you'll be dead before your 55. 3) In-hotel bar or restaurant with free Wi-Fi and friendly staff. Avoid the feeling of isolation and loneliness by getting to know the people that work there, especially the front desk people and the bartender. Hey you never know, you might be able to teach the bartender a thing or two about potent compound safety.

    Join the Loyalty Programs

    Take advantage of every customer loyalty program you can envision. Frequent flier programs are no brainer, especially if your company allows you to personally accumulate the miles. As a consultant in potent compound safety, occupational toxicology, and industrial hygiene for pharmaceuticals, I have received many free flight tickets that I've used for my family to travel places. Don't use the frequent flier miles for yourself or you won't get the miles for the trip. Use them for your family. Another benefit of enrolling in the customer loyalty programs is getting miles for elite status which may entitled you to early boarding and free upgrades. For rental cars, again it's a no-brainer, nothing is better than by-passing the long lines at the counter and heading straight to your car. Keys in the ignition, show the guy your license, and you're gone. For hotels, most hotels have sophisticated databases that know how many times that you have stay there and if you make it to a certain level they will jump through hoops for you. Again, another reason to stay at the same place.

    I should mention that as you join customer loyalty programs, you will accumulate a lot of cards - don't put them in your wallet or purse. Instead, go to to one of those leather store in the airport or mall, and buy one of those long leather wallets where you can stash all your loyalty cards. If you can, stash a way a couple of extra twenty dollar bills in there as well. You don't know when you might need it.

    If travel more than twice a month, you should consider joining one of the airline clubs. Depending upon the airline, you can get free wi-fi, comfortable seating, snacks, and free drinks. You'll be thankful you joined the day you get delayed for several hours.

    Take Advantage of Technology

    When you travel a lot, you have to be organized and travel light. Even if you have to pay for it out of your own pocket, get a great smartphone and a light laptop. In addition to a decent phone, your smartphone should have a great GPS mapping system, otherwise you're going to get lost, a digital camera, a calendar system, a digital music player, and the ability to install apps. Carry as few of books or papers as you can or you're going to hate life carry all this crap through the airport. Especially, with the way security is these days. So, let's just assume you're not big on listening to music. That's o.k., then listen to podcasts, in addition to the Biopharma EHS podcast, there are many other great podcasts or digital books out there. Get with the program and use technology to your advantage. Use digital technology to record notes. Programs like Evernote work great for recording all the tidbits of information. For compliance related items such as regulatory compliance tasks and corrective action software, I use Affytrac. In order to be an effective road warrior, you must be able to retrieve information quickly and without saying "Uhh, it's back at the office." Remember that effective Road Warriors has no office. Your office is in your bag on your shoulder and on your phone. Another benefit with recording compliance related tasks digitally is that if your bag or laptop gets lost or stolen, it's simply a manner of changing your password and all is good.

    While we're on the subject of apps you might want to check out Affytrac Mobile - a simple and affordable way for you to manage all your compliance and corrective action management system requirements from the convenience of your smartphone. If you have questions about Affytrac Mobile, give me a call on my mobile phone at 303-884-3028.

    Still on the subject of apps, I should mention that restaurant apps such as Yelp or Urban Spoon are also great for finding that great restaurants. You can use location-based apps such as Foursquare or Gowalla to check-in and keep a virtual "journal" of your trips. Make it fun and don't worry about oversharing.

    Get to know the Local Environmental, Health and Safety Community

    Chances are that if you're visiting a specific facility frequently, that the people you need to meet can't be available for the entire time that you're there. This is especially true if you're there more than once a month. Also, in general, these people will likely have family obligations and having to entertain you every evening while your there gets old. Don't wear out your welcome and find something else to do, but at the same time make good use of your time. With a little bit of research, you might find that the local chapter of the American Industrial Hygiene Association, or the American Society of Safety Engineers, or some other professional organizations will either have a lunch or dinner meeting at certain times of the month. Schedule your routine trips for those times and attend those meetings. In addition to meeting new people, you begin to get a deeper understanding of the local regulations.

    Stay Connected Back Home

    O.k. you may be so old school that your idea of technology adoption is using a mechanical pencil - get over it and learn some new stuff. The world is not going to rewind to your style and you have to learn new skills or you will get replaced. You should also consider that maybe, just maybe, that those evening hours alone in the hotel bar or in your room are just the time to learn them. If you're a Road Warrior you really need to be on LinkedIn and Facebook in order to stay socially connected to the the new professional friends that you meet while on the road and the family you have back home. Don't be afraid to post pictures of that really cool castle that you drove by when you where going to a potent compound safety review meeting in the middle of Germany. People love that stuff. They want to see you as a real person, not some robot. While I'm on that subject you can connect with me on LinkedIn and Facebook. Please invite me to be a connection on LinkedIn and "Like" us on Facebook. In either case just search for "Affygility Solutions" and you will find us.

    Go with the flow

    Traveling on business is full of unexpected things. No need to stress out about it, and be nice to people. During my travels, I've run into more than my fair share of jerks. You know the ones that act like they are the only ones that matter - yelling at everyone that crosses their path, cutting in lines, and just about every rude act you can image. My feeling, if you hate traveling that much find another job.

    Well, that does it for the Road Warrior segment of today's episode. I'm sure many of you out there have lot's of other great suggestions, so feel free to email at [email protected] or call them in to me.

    Next, let's go over some important events and happenings that may be of interest to environmental, health and safety professionals in the Biopharma industry.

    Discuss events

    30 min
  • Biopharma EHS Podcast Episode #8

    Biopharma EHS Podcast Episode #8

    Oh yay everybody, that’s right.that’s right..how are yay? Folks it’s Tuesday, February 1st, 2011 and that’s right, we’re back we’re back for another episode of the BioPharma EH&S podcast.

    So what’s on our agenda for today? Our agenda for today on the Biopharma EH&S podcast is the following. AS ALWAYS I’ll briefly cover what we talked about last time , then I’ll jump right into a discussion on the Future of Environmental, Health and Safety, and then, and then, we will then cover events and happenings of interest to environmental, health and safety professionals in the biopharma industry. So, without further ado let’s get after it.

    Alright, in the last episode – episode 7 our main topic was management commitment and involvement – how to obtain and sustain it. In that episode I indicated that one of the most important things to consider to consider, is to know exactly what you want and try to understand what they want and the important issues on their plate. So, if this is a topic that interests you, I would strongly suggest that you go back and listen to episode 7.

    O.k. folks our next topic for today is the future of environmental, health and safety. So, looking ahead looking ahead at the environmental, health and safety profession, the field, what’s going to happen in the next 10 – 15 years. Let’s call it EH&S 4.0 Yeah that will work – let’s call it EH&S 4.0. As most people know making predictions 10 -15 years out is pretty tough to do. In most cases we don’t do a very good job of predicting want is going to happen week. And we always run the risk of some disruptive technology or issue happening that could cause some sea change of activity, something we didn’t think of, if you will, in another direction. But let’s go ahead and give it a shot based on trends that are occurring today.

    The trends that I will be talking about center mostly around three main areas – technology, regulatory, and societal. The first trend , the first trend that will have a significant impact on all environmental, health and safety professionals is what I call:

    The Untethering of the Workplace

    In the past, the workplace, the workplace as we know it, was traditionally a fixed location where everyone would typically work a somewhat fixed set of hours and days of the week. When the economy in the U.S. was primarily driven by industrial manufacturing this made sense, but but as the U.S. economy shifts more to a knowledge-based economy, the added overhead expense of a fixed office space no longer makes economic sense. In addition, communication technologies have improved to the point where it is no longer necessary to have everyone in the same physical location to effectively work together on a project. As an aside, I know a pharmaceutical company that uses Halo Collaboration Studio by HP and , in a sort of Star Wars like fashion you feel like you have Obi-Wan Kenobi sitting next to you. So, being in the same physical space is no longer necessary. Therefore, therefore, as companies continue to seek out the best talent in the world, that talent may come from anywhere in the world. Sure, for research and development centers we will still need fixed locations, but even then, but even then, research clusters are becoming so predominant that sharing of workspaces on as needed basis will become more popular. This will present unique, unique challenges for traditional occupational health and safety programs in determining who is the host employer, this will present challenges in conducting EH&S training, and as I will talk about later you will see an explosion in just-in-time training.

    The second major trend I would like to call “There’s an “App for that”

    I’m not sure how many of your have a smartphone, but look for a significant increase in smartphone applications or as they call it “apps” for industrial hygiene, environmental compliance, health and safety. Before I get into a lot of detail, maybe may I should first define what is a smartphone A smartphone is a mobile phone that offers more advance computing power and connectivity than a traditional mobile phone. Smartphones typically are equipped with a mobile phone, web browsing capabilities, a global positioning system (a.k.a. GPS), a digital camera, and the capability to run small application programs know as “apps”. These apps are typically digitally downloaded from the Internet for little or no costs. The ones that are free typically come with ads, the ones that aren’t free don’t. As of today, there already are apps for games, mapping, checking in to physical locations, getting reviews on just about anything, and much more. In the future in the future your smartphone will become an industrial monitoring device – handling all sort of things - chemical, biological, and physical exposure information. Monitoring for potent compound safety won’t be an issue, you will just program the molecule into your app and woala, instant monitoring. Even today, even today, my smartphone – which is an iPhone - has a sound level meter app. I’ve compared it’s reading to those measured by sound level instruments costing hundreds of dollars more and it’s relatively close. Technology will only get better.

    In addition to Apps, RFID tags or similar technologies will be embedded in your phone to make it location aware. Filling out information on the location of industrial hygiene monitoring will no longer be necessary – your smartphone will know. Heck, industrial hygiene instrumentation should already have these tags built in – it’s not that difficult. For those of you that personally know me – I do a lot of snow skiing in the winter. My ski pass has a RFID tag built into it and tracks every lift I boarded, and how many vertical feet, ski days and runs that I skied. It’s not that hard.

    On the environmental side, there will be complete data collection of facility inputs and outputs that will all be readily available and controllable on your smart phone. No longer will environmental professionals have to spend countless hours collecting data on hazardous waste generation, electric utility and water usage, and solid wastes generation. All this data will become available real-time and at your fingertips on your smartphone.

    We haven’t we haven’t even, even to begun to see the potential use of these devices. Here at Affygility Solutions we recently released Affytrac Mobile – a cross platform compliance management software web app that helps busy environmental, health and safety professionals manage their programs across multiple facilities, languages, and time zones. Look for more great things from Affytrac, including potent compound safety on the go.

    O.k., so that covers, there’s an App for that. The next main trend I’d like to discuss is Managing health and safety of Crowdsourcing

    So what the HECK is crowdsourcing? Well, crowdsourcing is the act of outsourcing tasks , outsourcing tasks traditionally performed by employees or contractors to an undefined large group of people through an open call. I know , I know that there are many of you that are saying – “well we’re different, we’re different, confidentiality issues and the intellectual property issues will prevent this”, regardless of those issues it WILL happen, IT WILL HAPPEN – because the knowledge of the crowd will be greater than anyone company.

    So with crowdsourcing, , with crowdsourcing, I might ask who will be the employer? Who will be the one responsible for the health and safety of the as we may call it “the crowd.” Think about it – this will be a challenge.

    Just-in-time EHS training

    Along with the end of the traditional workplace and the increase in crowdsourcing, methods to provide the required environmental, health and safety training in a just-in-time fashion will be necessary. This can easily be done for those training requirements that are primarily information transfer, but what about those activities that require a hands-on component?

    Conferences will become much more social

    Conferences as we know it will be a thing of the past. Most environmental, health and safety professionals know that the real experience and knowledge learning from a conference doesn’t come from the speakers – most speakers aren’t that great – the real knowledge comes from the crowd – from the attendees themselves – the ones in the hallway. As I was writing this article I had, I had to ask myself “Is there such a thing as a Certified Social Hygienist?” and what the heck I found a link to: Social Ergonomics

    http://www.mydutchdream.com/svh-social-hygiene-certificate/

    I’ll post the link in the show notes – so check it out.

    The final trend the final trend that I would like to present is what I’d like to call “Toxicology on a chip.” We will see , we will see in the very, very near future, the ability for a company to put a small amount of a research compound on a computer chip and have all the occupational toxicology information we could possibly need – and it will categorize, classify - whatever information we need. Why do I believe this? Because of the market and the market drives innovation. Today – it’s too expensive too time consuming for companies to conduct all the necessary tests for drug safety, potent compound safety classification, IATA and DOT classification, REACH, GHS information and many other requirements. In the future – put it on a chip – print the potent compound safety classification report and the MSDS.

    So folks, that does it for the Future of Environmental, Health and Safety.” If you have any questions or comments – please call our listener voicemail feedback line at 206-984-3214. That’s 206-984-3214.

    O.k. Let’s now discuss events, events and happenings – you know – the things that are important to environmental, health and safety professionals – the things that make you look forward to doing your JOB.

    The first event is the National Association for Environmental Management – MIS conference in San Antonio, Texas – yay, that’s right, San Antonio, TX on March 2nd and 3rd. I’ll be there talking up Affytrac Mobile. If you would like to hook up with me – please call me at 303-884-3028.

    The next event is South by Southwest – oh yay major event. I was at the pre-party in Boulder, Colorado last night and the host said that last year there was over 14 thousand people there. Again – call me – let’s meet.

    Alright, we’re nearing our time limit for today, so I need to end today’s session. As always you can stalk us on twitter at twitter.com/Affygility, connect with me on Linkedin, or Like us on Facebook by searching for Affygility Solutions.

    That does it for this week’s podcast – see you next week. Please call our listener voicemail feedback line at 206-984-3214. Have a great rest of the day.

    26 min
  • Biopharma EHS Podcast - Episode No. 7

    Management Commitment and Involvement - How to obtain it and sustain it for your EHS Program.

    Introduction.

    Review last time.

    Main topic: "Management Commitment – how to obtain and sustain it.”

    Upcoming events and happenings of importance to environmental, health and safety professionals in the BioPharma Industry.

    Important announcement to talk about and I’m very excited about this, and I believe you will be too.

    Episode 6 we discussed some of key regulatory agenda items for 2011. Those items on OSHA’s regulatory agenda and having the most impact on the Biopharma industry are I2P2 or injury illness and prevention programs, and the pending finalization of the revisions to the hazard communication standard.

    Key parts of I2P2 are likely to be management commitment, employee involvement, and hazard identification. OSHA has indicated that this is their key regulatory agenda item for this year. If you want more details on that discussion, I would suggest that you go back to Episode 6 and listen. You should also stay tuned to the BioPharma EHS podcast for updates on I2P2 in future episode.

    We then discussed, how OSHA was indicating that they hope to have the revised hazard communication standard that incorporates the global harmonization system elements into the standard completed by August of this year. I did mention in that podcast, that these changes will require significant changes to material safety data sheets, and package labeling. Which also means that you will have to update your written program, your training programs, and re-train employees. Again, I would suggest that you go back to Episode 6 and listen in.

    Well, the discussion on I2P2 and management commitment, leads us into our next topic - Management Commitment – how to obtain it and sustain it.

    Often hear EHS managers state, “If I just have management commitment. If I just have management involvement. Our progress would be so much better.” Well, first off, any experienced environmental, health and safety professionals knows that “yes” management commitment and involvement is a critical component to a successful EHS program, but as I always tell EHS managers, be careful what you ask for and know exactly what your asking.

    Because when you start asking for senior management to be deeply involved in your program, along with that involvement comes a significant increase in accountability and a lot of work on your part. And if your strategies, your goals, your objectives, don’t deliver on their promises – then senior management may be looking carefully at your ability to make strategic decisions and execute them.

    So, before you start asking for their involvement you need to know what you want and what they want.

    · First off, gain a solid understanding of what your company does, the key strategic goals for the next several years, and gain an understanding of their current business cycle – is the business in a rapid growth mode or downsizing mode? If often surprises me, how few environmental, health and safety professional understand the company that they work for in terms of strategic direction, product and service offerings, and the overall business.

    · You also want to understand who the key influencers in the organization are and why? – who has the ear of the CEO? Who does the CEO listen to?

    · Second, understand the language of the CEO. It’s been my experience that you can tell a lot about the type of language that they want to hear by understanding their education and background. Prior to becoming a CEO was their experience in finance, sales and marketing, operations, or science? In the biotech industry, it’s very common to have CEOs with a science background. I’ve heard that in the past several years this has been changing, but if science is their language, then whatever strategies that you propose better speak the language of science and be about furthering the science of the company.

    · Once you have some understanding of the company and the background of some of its senior management – pick a few strategic targets where you can involve senior management and get some early success. One example is drafting an overall corporate environmental, health and safety policy and getting it endorsed by senior management.

    · Next what visible, actionable items do you want management to be involved in? In the biotech/pharma industry several things that I’ve seen that have work well is at least one senior manager being present in all safety committee meetings. Ideally, it should be on a rotating basis. At first it may be intimidating for the staff level employees, but it does show the employees that management is willing to spend their time on safety. One important point here – make sure you have prepared and distributed an agenda ahead of time, and have defined start and stop times. This can’t be an ad hoc meeting. Another example of management involvement is senior management participating in walk-through inspections of laboratories and manufacturing area. I should mention an important point here – make sure that your senior managers are wearing all the appropriate personal protective equipment such as safety glasses, lab coats, and whatever else your company requires. Nothing causes an EH&S programs to lose credibility more than senior managers going through work areas without the proper protective equipment. I always can tell the company’s that have developed strong EH&S programs when annual reports have photos of executives in the lab, and they are always wearing their PPE. Why is that so rare? Well, taking professional photos of people wearing safety glasses is a real trick. Because you get a lot of reflection and glare off the lens, professional photographers don’t like them and don’t want to spend the extra amount of time to get it right.

    · After you have decided on one or two things you would like to propose that senior managers be involved in, setup a meeting with the highest ranking member of management that you can get access to. If it’s the CEO – great! If it’s the site head – that’s o.k. But regardless of who you’re attempting to get access to – you may want to keep your direct supervisor informed or they might get blindsided.

    · Prior to meeting with them. Make sure you have a plan on what you would like to discuss. One page of bullet items is fine. Stay focused and don’t get off topic, unless they want to discuss other issues. Be open to their suggestions. They may be better than yours. You should also be careful, not to overstay your welcome or future meetings with them will become difficult.

    · O.k. now that you have proposed some ways for managers to be engaged, what measurements are you going to keep to ensure progress in the right direction. Without some kind of meaningful measurement you won’t be able to sustain your efforts. Management wants to see that however they spend their valuable time is resulting in progress for the company. You likely will need several metrics and a combination of leading and lagging indicators. Make sure your metrics are credible. Software tools like Affytrac, our proprietary compliance management software, can be extremely helpful in tracking completion of actions..

    · Finally, now that you have their attention, it is your responsibility to provide updates to senior management. Use metrics as previously noted, as well as other important items and achievements. EH&S reports don’t always have to be always negative news. Be sure to mention the things that are going right. Focus on progress. Keep your report short and condensed down to 1 or 2 pages. Use graphs where possible. Comparison graphs are great. Management is used to looking at these types of graphs. These reports should be provided at least quarterly.

    · After you have gain the confidence and trust of senior management, and you have a few solid systems in place, you can further advance the progress of the EH&S program by establishing an executive level EH&S committee. While this may be a stretch for some companies early in the development of their environmental, health and safety program, it is something to aim for.

    So, yes management commitment and involvement is key. If you’re an EH&S professional working full-time at a company, then there has already been some level of commitment demonstrated just by allocating a full-time position to handle these issues. But, there are also some simple things that you can have senior management be involved. Take some small steps and you will see some progress.

    O.k. The does it for the discussion on management commitment. If you have any comments or feedback – I loved to hear it. You can call our listener voicemail feedback line at 206-984-3214 and leave an audio comment. You don’t need to leave your last name or anything like that. You can also email us your comments at podcast at Affygility.com.

    Alright, let’s now talk about some great upcoming events.

    The first event is the National Association for Environmental Management Conference to be held on March 2nd and 3rd in San Antonio, Texas. I will be attending this event, so if you would like to meet up with me, please feel free to call the listener voicemail feedback line and let me know that you’re going to be there.

    The second event is the Society of Toxicology meeting on March 6th through 10th in Washington, DC. Dr. Joe Nieusma, Senior Toxicologist with Affygility Solutions will be attending this event, so if you would like to meet with Joe let me know.

    Next, on March 11th through 15th, I will be attending South by Southwest Interactive in Austin, Texas. This is going to be an exciting event and I look forward to hooking up with my good friends from E-Webstyle. They are the "A" team of Search Engine Optimization from Houston, TX I’ve never met them face-to-face, but we have known each other virtual for several years now. I look forward to meeting them in person.

    I should also mention, that in April, we have several new EHS webinars starting and you should get out our schedule at Affygility.com. These webinars have been very well attended and we have received a lot of positive feedback on them. Also for those of you that are Certified Industrial Hygienist, you get 1.5 certification maintenance points for completing all 5 modules of the Advanced Topics in Potent Compound Safety webinar.

    Alright, now for some very exciting news. Just yesterday, Affygility Solutions announced the launch of Affytrac Mobile. We are extremely excited about this innovative product and how it makes managing compliance programs so easy, and from the convenience of your smartphone. Affytrac Mobile is the first fully functional environmental, health and safety mobile phone app. Affytrac Mobile works from your iPhone, iPod touch, Android devices, and certain Blackberry Smartphones. Check it out by going to Affygility.com. We will be having a webinar going over the features of Affytrac Mobile this next Monday, January 31st, 2011 at 9:30 a.m. The webinar should last approximately 30 minutes. Please go to Affygility dot com to register for this free webinar.

    Remember to submit your questions to our voicemail feedback line at 206-984-3214. You can also stalk us on twitter at twitter.com/Affygility, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.

    19 min
  • BioPharma EHS Podcast Episode #6

    I2P2 and GHS - important OSHA regulatory issues for 2011. In this episode of the BioPharma EHS podcast, Dean M. Calhoun, CIH - President and CEO of Affygility Solutions discusses two of OSHA's regulatory issues for the calendar year 2011 that will effect the biotechnology and pharmaceutical industry. The first issue is OSHA's Injury and Illness Prevention Program, and the second is the Global Harmonization System for Classifying and Labeling Chemicals.

    In you have a question regarding an environmental, health and safety issue please call our listener voicemail feedback line at 206-984-3214 or contact us online.

    21 min
  • BioPharma EHS Podcast Episode #5

    In this episode of the BioPharma EHS Podcast, the top 10 OSHA violations in the biotechnology and pharmaceutical industry are discussed by Dean M. Calhoun, CIH, President and CEO of Affygility Solutions. These common violations include the respiratory protection standard, hazard communication, lockout/tagout, machine guarding, electrical, walking surfaces/space, and occupational exposure to hazardous chemicals in laboratories. In order to avoid these types of violations, companies of all sizes should implement a compliance management software solution.

    22 min
  • BioPharma EHS Podcast Episode #4

    Occupational health and safety never takes a vacation. In this episode of the BioPharma EHS Podcast, Dean M. Calhoun of Affygility Solutions discusses the problem with having an environmental, health and safety program that relies heavily on one person, and he offers advice on how to build a sustainable program that has bench strength.

    Other announcements include:

    The upcoming Dermal Exposure and Absorption of Active Pharmaceutical Ingredients Webinar

    The upcoming Advance Topics in Potent Compound Safety Series webinar

    The National Association for Environmental Management (NAEM) Management Information Systems conference in March, 2011. Affygility Solutions will be there, and if anyone has questions about Affytrac - the environmental, health and safety compliance management software tool for the life science industry, please stop by.

    South by Southwest Interactive Conference in mid-March 2011.

    26 min
  • BioPharma EHS Podcast, Episode #3, December 19th, 2010

    Call 206-904-3214 for our listener voicemail question and feedback line. In this episode, Dean M. Calhoun, President and CEO of Affygility Solutions discusses how to become an environmental, health and safety rockstar, and has an interview with Joseph Logan, President of Global Advisors. In this interview, Joseph discusses the amount of waste that occurs in the implementation of information technology projects, and how to avoid some of those pitfalls. Dean also gives a shout out to Chris, Paul, and Chuck over at E-Webstyle.

    31 min
  • BioPharma EHS Podcast - Episode #2, December 12, 2010

    Call 206-984-3214 for our listener voicemail question and feedback line. This line is open 24 hours per day. Questions regarding potent compound safety, occupational toxicology, industrial hygiene, containment validation, compliance management software, etc. in the biotechnology, pharmaceutical, and medical device industry are appropriate. Please limit your questions to less than 3 minutes.

    In this episode of the Biopharma EHS podcast, Dean Calhoun, CIH of Affygility Solutions, discusses the following:

    The blog post "Potent Compounds - 7 things that every environmental, health and safety professional should know." This was an article written by Dean several months ago and posted on the Affygility Solutions website.

    A telephone interview with Dr. Joe Nieusma, Senior Occupational Toxicologist with Affygility Solutions, regarding the categorization of potent compounds.

    Upcoming events, including Affygility Solutions Unplugged- Foster City. This event will be held at the Club Bistro inside the Crowne Plaza Hotel in Foster City, CA on December 14th, 2010 from 5 - 7 p.m. Come meet Dean Calhoun of Affygility Solutions. He will be wearing the gray long sleeve shirt with an Affygility Solutions logo over the pocket.

    31 min
  • Biopharma EHS Podcast - Episode #1, December 6th, 2010. Introduction to the podcast, surviving a regulatory inspection
    BioPharma EH&S podcast episode 1 December 6th, 2010 Hello everyone welcome to the inaugural episode of BioPharma EH&S podcast, my name is Dean Calhoun and this IS THE podcast where I will discuss environmental, health and safety issues affecting the BioPharma Industry. I’m here to help answer any questions you may have regarding: * potent compound safety * occupational toxicology * compliance management software. I’ll talk more about that later, how you can submit questions to the podcast. Well today, we have a lot to tackle today so let’s get started. One of the first things that I’d like to do, is at the beginning of each podcast is tell you the different topics that I plan on covering in this particular episode. So, the first thing I’d like to cover today is the general format of this podcast, and how YOU can submit questions or feedback to this podcast. Secondly, I’ll cover the type of audience that this podcast is intended for. Then, I’ll cover challenges that environmental, health and safety professionals in the biopharma industry face. How to survive a regulatory inspection And finally we will end the podcast by discussing any upcoming events of interest, and the main topic we will be discussing in the next episode. So let’s get started with the General Format that each episode will follow. 1. ~30 minutes long 2. Start out with brief overview 3. Once a week 4. Submit question to [email protected] 5. iPhone voice memos, record 6. Leave a message on our listener voicemail feedback line at 206-984-3214. Next after the overview of the topics, we will jump into discussing each of them. Depending on the depth of the discussion we may only get to discuss one or two of them. Topics that could be discussed include all kinds of things, including potent compound safety, occupational toxicology, industrial hygiene, containment validation, managing regulatory requirements, compliance management software, and environmental issues. We may also get into career development for environmental, health and safety professionals We also would like to see about getting an online interview or two going. If anyone has something important to discuss, send me an email and I can arrange something. Finally, in each episode, I will wrap the podcast up by discussing any upcoming events that you may want to watch out for. Alright. So, let’s get onto our next topic is “who is this podcast intended for.” This podcast is intended for practicing environmental, health and safety professionals in the BioPharma industry. The audience that this is really for the EH&S professional that is dealing with these issues on a day-to-day basis. The person that is in the trenches getting it done. We really want those people to be involved. While we may discuss some strategic and theoretical issues, we really want to have those hands-on folks to participate. We really encourage you to submit questions. I should mention that when I’m talking about the BioPharma industry I actually mean biotechnology, pharmaceutical, medical device, and related industries. Now with all the administrative overview stuff out of the way, let’s talk about the unique challenges that are presented to EH&S professional in the Biopharma industry. First off it’s a heavily regulated industry. Besides the regulatory demands of the drug approval agencies, Biopharma companies have to deal with occupational health, biosafety, chemical exposure, hazardous wastes, radiation safety, hazardous materials transportation safety, and many other regulatory requirements. For smaller BioPharma companies, these complex requirements may fall upon the shoulders of maybe just one person. Just yesterday, I was working with a client that not only has EH&S responsibilities, but also has laboratory support, purchasing, and facility support. Yes, they’re a small startup company, but the regulatory requirements are still there. The second challenge is, that you may be dealing with highly potent novel compounds. These compounds may be very early in the discovery phase with little or no toxicology or hazard information. However, you’re still expected to provide the necessary controls and training to protect your employees from adverse health effects. Finally, the pace and pressures of the BioPharma industry can be intense. As an EH&S professional in this industry, you have to understand that you need to do whatever you can so that you don’t delay the drug development time-line. Do that once and it will be a short career at your current company. Alright now, let’s move on to the next topic – surviving a regulatory inspection. 1. Preparation begins well before an inspection a. Records in order b. Train your employees 2. Be nice. 3. Determine why they are there. 4. Don’t give the dog and pony show 5. Don’t answer a question that wasn’t asked 6. Silence is golden 7. Provide only the records that are requested. Copy those provided. 8. Provide quick follow up 9. Learn from the event Well that does it for this week’s podcast, But before we go One brief announcement, for those of you in the San Francisco Bay Area, Affygility Solutions will be hosting Affygility Solution’s Unplugged at the Club Bistro inside the Crowne Plaza in Foster City on December 14th from 5-7 p.m. Stop on by and say hi. I would love to meet you. I’ll be wearing a grey shirt with a Affygility Solutions logo over the pocket. [play exit music] That does it for now, in next week’s episode, I will be discussing at what point of drug development that should you start categorizing a potent compound. Again, please email your questions to [email protected] or call our listener voicemail feedback line at: 206-984-3214
    15 min

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BioPharma EH&S Podcast. The latest discussion on potent compound safety, occupational toxicology, industrial hygiene, and compliance management software. To submit questions or comments to the…