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Introducing OEL Fastrac+: The Ultimate Database for OEL and ADE Values
Welcome to the official launch of OEL Fastrac+, the cutting-edge subscription-based service designed specifically for occupational health and safety professionals and cleaning validation experts in the pharmaceutical manufacturing industry.
In this video, we unveil OEL Fastrac+, an innovative database that provides accurate and up-to-date occupational exposure limits (OEL) and acceptable daily exposure (ADE) values for active pharmaceutical ingredients. With OEL Fastrac+, you gain access to comprehensive, fully-compliant reports that adhere to the stringent regulatory requirements of the FDA, EMA, PIC/S, ANVISA, and WHO.
Key Features of OEL Fastrac+:
Extensive database of OEL and ADE values for active pharmaceutical ingredients.
Easy-to-navigate interface for quick and efficient data retrieval.
Regular updates to ensure compliance with the latest regulatory standards.
Detailed, fully-compliant reports tailored to meet global regulatory requirements.
Whether you are an occupational health professional ensuring workplace safety or a cleaning validation specialist maintaining product integrity, OEL Fastrac+ is your trusted partner for reliable, regulatory-compliant information.
Don't miss out on the opportunity to streamline your compliance processes and enhance workplace safety. Contact us today for a free demo: affygility.com/oel-fastrac-plus/kickstart/
🔔 Subscribe to our channel for more updates and tutorials on how to maximize the benefits of OEL Fastrac+.
👍 Like and share this video if you found it helpful.
💬 Leave a comment below if you have any questions or would like to learn more about OEL Fastrac+.
#OELFastrac #OccupationalExposureLimits #ADEValues #PharmaceuticalSafety #Compliance #FDA #EMA #PICS #ANVISA #WHO #SafetyDatabase #PharmaceuticalManufacturing
มุมมอง: 17

วีดีโอ

OEL Fastrac wins prestigious CPhI Award for Excellence in Pharma: Regulatory Procedures & Compliance
มุมมอง 1044 ปีที่แล้ว
OEL Fastrac™ is an innovative online service by Affygility Solutions that provides life science professionals with high-quality documents containing the necessary information to properly classify potent compounds and protect their employees from the hazards of potent active pharmaceutical ingredients. In addition, at no additional cost, OEL Fastrac monographs contain the acceptable daily exposu...
Is my API cytotoxic, genotoxic or a hormonal compound?
มุมมอง 1685 ปีที่แล้ว
In this short video, Dr. James Damewood, PhD, DABT, Senior Director of Occupational Toxicology for Affygility Solutions answers questions on cytotoxic, genotoxic and hormonal compounds. This video was recorded live from the Affygility Solutions all-hands meeting held in Philadelphia, PA on June 11th, 2019. Affygility Solutions provides occupational toxicology and industrial hygiene services to ...
High potent medicines conference 2019 milan italy
มุมมอง 1035 ปีที่แล้ว
From the High Potent Medicines conference held in Milan, Italy, Affygility Solutions' President Dean Calhoun gives a brief update.
Need an OEL or PDE? Look no further!
มุมมอง 155K5 ปีที่แล้ว
Need an occupational exposure limit (OEL) or permitted daily exposure (PDE)? Look no further. The expert toxicologists at Affygility Solutions can help you with all your occupational exposure limit or permitted daily exposure limit needs to meet the requirements of EMA/CHMP/ CVMP/ SWP/169430/2012. Easy, online ordering and download. Free guidance document.
Japan/Singapore trip while on client visit and speaking at ISPE Singapore
มุมมอง 727 ปีที่แล้ว
Whenever I travel internationally, I always trying to spend one day to better understand the culture. Knowing the culture is so very important in doing business internationally. Not everyone thinks like us, in fact, most don't.
Definition of a cytotoxic substance - Amazon Alexa knows!
มุมมอง 1397 ปีที่แล้ว
The definition of a cytotoxic substance, as explained by Amazon Alexa. To add Potent Compound Safety to your Alexa Flash Briefing go to: goo.gl/qTxXP7
Affygility Solutions - Online OEL and ADE monographs
มุมมอง 1617 ปีที่แล้ว
From the American Industrial Hygiene Association meeting in Seattle, Washington, Peter Burke and Dean Calhoun of Affygility Solutions discuss OEL Fastrac. A simple way to obtain occupational exposure limit (OEL) and acceptable daily exposure (ADE) value monographs for active pharmaceutical ingredients. To view our entire catalog listing, go to the following link: goo.gl/fSi2GH
Overview of the ChemoAlert surface sampling kit to ensure compliance with USP 800
มุมมอง 957 ปีที่แล้ว
In this short video, Dean Calhoun of Affygility Solutions interviews Matt Meiners of Maxxam Laboratories about the new ChemoAlert test kit for surface sampling of antineoplastic chemotherapeutic drugs to ensure compliance with USP 800. Links to resources: ChemoAlert kit: www.maxxamlabs.com/services/pharmaceutical-industrial-hygiene/ChemoAlert/ Occupational Exposure Limits (OELs) and Acceptable ...
Does your potent compound safety program need improvement?
มุมมอง 1087 ปีที่แล้ว
Does your potent compound safety program need improvement? Contact the potent compound safety experts at Affygility Solutions to assist your company with occupational exposure limits (OEL), acceptable daily exposure (ADE) and permitted daily exposure (PDE) values for active pharmaceutical ingredients, containment validation, industrial hygiene, potent compound safety gap assessment, and much mo...
Occupational health categories vs. control banding
มุมมอง 7297 ปีที่แล้ว
In the context of potent compound safety, what is an occupational health category vs. a control band? Are they different, and if so, how do they relate to each other? In this video, Dean Calhoun, CIH of Affygility Solutions answers this question.
Acceptable daily exposure (ADE) values and their application to cleaning validation
มุมมอง 5K10 ปีที่แล้ว
Acceptable daily exposure (ADE) values are an essential component of determining the amount of maximum safe carryover (MSC) in a multi-product pharmaceutical manufacturing facility. In this episode of Whiteboard Friday, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions discusses ADEs (PDEs) and their application in Cleaning Validation. For the purpose of this discussion, the term ...
Whiteboard Friday: What determines Category 1-4, biological activity or the OEL?
มุมมอง 1.1K10 ปีที่แล้ว
"What determines Category 1-4 [of a potent active pharmaceutical ingredient], the biological activity or the occupational exposure limit (OEL)? In this episode of Whiteboard Friday, this question is answered by Dean Calhoun, President of Affygility Solutions. To submit your potent compound safety questions, you can either submit via twitter to @affygility #potentsafety or go to affygility.com a...
Surrogate monitoring, control banding, and potent compound safety
มุมมอง 58510 ปีที่แล้ว
Surrogate monitoring, control banding, and potent compound safety
Corrective Action Software for EHS
มุมมอง 14011 ปีที่แล้ว
Corrective Action Software for EHS
EHS software to manage compliance requirements and corrective actions
มุมมอง 1K11 ปีที่แล้ว
EHS software to manage compliance requirements and corrective actions
Affytrac - Task Assignment Completion
มุมมอง 5211 ปีที่แล้ว
Affytrac - Task Assignment Completion
Potent Compound Safety Training Preview.mov
มุมมอง 66512 ปีที่แล้ว
Potent Compound Safety Training Preview.mov
Occupational Exposure Limits (OELs) on Material Safety Data Sheets
มุมมอง 4.6K12 ปีที่แล้ว
Occupational Exposure Limits (OELs) on Material Safety Data Sheets
Methylene Chloride Safety Training Video Preview
มุมมอง 2.5K12 ปีที่แล้ว
Methylene Chloride Safety Training Video Preview
Isoflurane Safety Video Preview
มุมมอง 1.1K12 ปีที่แล้ว
Isoflurane Safety Video Preview
Global Harmonization System (GHS) Training Video Preview
มุมมอง 2.3K12 ปีที่แล้ว
Global Harmonization System (GHS) Training Video Preview
Does the form of the API change the occupational exposure control band?
มุมมอง 44112 ปีที่แล้ว
Does the form of the API change the occupational exposure control band?
Occupational Exposure Control Banding Pharmaceuticals
มุมมอง 2K12 ปีที่แล้ว
Occupational Exposure Control Banding Pharmaceuticals
Occupational Exposure Limits for Active Pharmaceutical Ingredients - OEL Fastrac
มุมมอง 1.7K12 ปีที่แล้ว
Occupational Exposure Limits for Active Pharmaceutical Ingredients - OEL Fastrac
Highly Potent Compounds - EHS Auditing of Facilities Handling these type of compounds
มุมมอง 1.1K12 ปีที่แล้ว
Highly Potent Compounds - EHS Auditing of Facilities Handling these type of compounds

ความคิดเห็น

  • @jsimmons493
    @jsimmons493 8 หลายเดือนก่อน

    Does the video include recommended spill clean-up procedures?

  • @avnendrayadav1019
    @avnendrayadav1019 5 ปีที่แล้ว

    I want to know that for Maco calculation, by using Ade value, batch size should be in no. Of in the liter or ML and maximum daily dose should be in no. Or mg.

    • @affygilitysolutions3100
      @affygilitysolutions3100 5 ปีที่แล้ว

      See this: help.oelfastrac.com/article/63-once-i-have-the-ade-what-equation-do-i-used-to-determine-the-maco

  • @chanhtringuyen9729
    @chanhtringuyen9729 5 ปีที่แล้ว

    Hi. How should the BW be applied? I mean what is the value of BW and what factors affect this value? Race, region, gender,...?

    • @affygilitysolutions3100
      @affygilitysolutions3100 5 ปีที่แล้ว

      Body weight is typically 50 kg, which is conservative. Any difference in race, region, gender, etc. would be adequately covered by AFh (UFh) for human variability.

    • @chanhtringuyen9729
      @chanhtringuyen9729 5 ปีที่แล้ว

      @@affygilitysolutions3100 Thank you for the answer. I see some companies use the value of 50, some use 60 and others use 70.. Also, the values are different in some guidelines.

    • @DeanCalhoun_affygility
      @DeanCalhoun_affygility 5 ปีที่แล้ว

      Nguyen Chanh It’s important to realize that the PDE (ADE) methodology is not precise. It is basically an extrapolation from a known dose to a dose which is expected not to cause harm even if exposed for an entire lifetime. If it was precise, you could then get into a huge debate on how long is a lifetime!

  • @swtechnologies7672
    @swtechnologies7672 8 ปีที่แล้ว

    A great video. Thanks for sharing

  • @peterburke7470
    @peterburke7470 10 ปีที่แล้ว

    Great video Dean!! Very insightful!!