“In working with Marc over the years at EMD, he has shown professionalism and a willingness to share his knowledge that benifits both the customer and the company. This trait to help made working with Marc both a leaning experience and pleasant atmosphere at work. I would higly reccomend him because of his willingnes to share and help.”
Marc Glogovsky
Absecon, New Jersey, United States
3K followers
500+ connections
Absecon, New Jersey, United States
3K followers
500+ connections
Activity
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It was such an honor to present and participate in a fabulous PDA - Parenteral Drug Association Annex 1 workshop in Dublin this week! Thank you to…
It was such an honor to present and participate in a fabulous PDA - Parenteral Drug Association Annex 1 workshop in Dublin this week! Thank you to…
Liked by Marc Glogovsky
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Tomorrow, ValSource Inc.’s Igor Gorsky is presenting, “Review of a Revision of PDA - Parenteral Drug Association Technical Report 29: Lifecycle…
Tomorrow, ValSource Inc.’s Igor Gorsky is presenting, “Review of a Revision of PDA - Parenteral Drug Association Technical Report 29: Lifecycle…
Liked by Marc Glogovsky
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I am proud to be a member of ICH Q6(R1) EWG and working with this fantastic group of people in Montreal this week on general principles for setting…
I am proud to be a member of ICH Q6(R1) EWG and working with this fantastic group of people in Montreal this week on general principles for setting…
Liked by Marc Glogovsky
Volunteer Experience
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Board of Directors
PDA - Parenteral Drug Association
- Present 1 year 11 months
Science and Technology
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ATMP Advisory Board (ATMPAB) - Member
PDA - Parenteral Drug Association
- 3 years
Science and Technology
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Science Advisory Board (SAB) - Member
PDA - Parenteral Drug Association
- 4 years
Science and Technology
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Interest Group Co-Chair - Microbiology/EM
PDA - Parenteral Drug Association
- 5 years 4 months
Science and Technology
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Education Advisory Board (EAB) - Member
PDA - Parenteral Drug Association
- 7 years 6 months
Science and Technology
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Member
PHSS - Pharmaceutical & Healthcare Sciences Society
- Present 8 years 5 months
Science and Technology
Recommendations received
1 person has recommended Marc
Join now to viewMore activity by Marc
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A great start to the PDA - Parenteral Drug Association Annex 1 Workshop! It was a pleasure to share the stage with Melanie Byrne Adams for back to…
A great start to the PDA - Parenteral Drug Association Annex 1 Workshop! It was a pleasure to share the stage with Melanie Byrne Adams for back to…
Liked by Marc Glogovsky
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What a great start to the 2024 Annex 1 Workshop in Dublin! #PDA #Annex1
What a great start to the 2024 Annex 1 Workshop in Dublin! #PDA #Annex1
Liked by Marc Glogovsky
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ValSource Inc.’s comprehensive suite of Manufacturing Science and Technology (MSAT) services is designed to streamline operations and empower…
ValSource Inc.’s comprehensive suite of Manufacturing Science and Technology (MSAT) services is designed to streamline operations and empower…
Liked by Marc Glogovsky
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Next week, ValSource Inc. Senior Consultant Stephen Langille, PhD, is presenting at the ECA Foundation & ECA Academy Visual Inspection of Parenterals…
Next week, ValSource Inc. Senior Consultant Stephen Langille, PhD, is presenting at the ECA Foundation & ECA Academy Visual Inspection of Parenterals…
Liked by Marc Glogovsky
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PIMSHQ capabilities include end-to-end, total project delivery through our unique partnerships with ValSource Inc., Inc. validation experts and EPREX…
PIMSHQ capabilities include end-to-end, total project delivery through our unique partnerships with ValSource Inc., Inc. validation experts and EPREX…
Liked by Marc Glogovsky
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PIMSHQ software helps bring large-scale projects to completion. Our technology offers a collaborative workspace of services to ensure speed-to-market…
PIMSHQ software helps bring large-scale projects to completion. Our technology offers a collaborative workspace of services to ensure speed-to-market…
Liked by Marc Glogovsky
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Thank you to everyone for attending the PDA Universe of Pre-Filled Syringes and Injection Devices Conference this past week! We hope you had a great…
Thank you to everyone for attending the PDA Universe of Pre-Filled Syringes and Injection Devices Conference this past week! We hope you had a great…
Liked by Marc Glogovsky
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Exciting News: Welcoming Harit Sharma as Our CEO! We are excited to announce that Harit Sharma has been appointed as the Chief Executive Officer of…
Exciting News: Welcoming Harit Sharma as Our CEO! We are excited to announce that Harit Sharma has been appointed as the Chief Executive Officer of…
Liked by Marc Glogovsky
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PIMS SAFETY software makes reporting safety observations easy and efficient by fostering engagement and encouraging participation throughout your…
PIMS SAFETY software makes reporting safety observations easy and efficient by fostering engagement and encouraging participation throughout your…
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Today I had the privilege of visiting the Alexander Fleming Laboratory Museum on the campus of St. Mary’s Hospital in London. As a Microbiologist, it…
Today I had the privilege of visiting the Alexander Fleming Laboratory Museum on the campus of St. Mary’s Hospital in London. As a Microbiologist, it…
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The FDA has issued two new draft guidances on Bioresearch Monitoring program (#BIMO) inspection preparation. The second, linked here, details what kinds of records and information sponsors must have available during inspections as well as the best ways for sponsors to communicate with the FDA. What do you think of the guidance? https://lnkd.in/ebajH3GE #QA #QAaudits #Biomonitoring
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BIOBOSTON CONSULTING
𝗖𝗼𝗺𝗽𝗼𝘂𝗻𝗱𝗶𝗻𝗴 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 𝗳𝗼𝗿 𝗦𝘁𝗮𝘁𝗲𝘀 𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝗨𝘀👉https://lnkd.in/e52sdG3P The FDA’s compounding program collaborates closely with state officials in various ways, including: 🔸Information Sharing: The FDA shares details about compounders with poor practices, complaints, adverse events, and inspection findings. States are also invited to participate in inspections. 🔸Support and Testimony: The FDA supports state actions by providing testimony and hosting annual intergovernmental meetings to address mutual concerns and improve federal/state collaboration. 🔸State Oversight: States primarily oversee the thousands of compounders in the U.S., most of which do not register with the FDA. They often first identify problematic compounders. ▶ Drug Quality and Security Act (DQSA): Section 105: This section allows state boards of pharmacy to submit information to the FDA about actions against compounding pharmacies or concerns about non-compliance with section 503A of the FD&C Act. The FDA, in turn, notifies states about such submissions or determinations. Information-Sharing Agreements: Federal law mandates agreements (e.g., FDA Commissioning, 20.88 Agreements) to share non-public information. Standard Memorandum of Understanding (MOU): 🔸Development and Legal Challenge: Created in consultation with the National Association of Boards of Pharmacy, the MOU addresses the interstate distribution of compounded drugs and complaint investigations. After a legal challenge, the FDA is required to ensure the MOU does not significantly affect small businesses or to conduct a regulatory flexibility analysis. ▶Recent Actions: Desiccated Thyroid Extract: In 2022, the FDA sent letters to state boards about DTE products prepared by state-licensed pharmacies. The FDA and states must continue collaborating to address and mitigate risks posed by compounding practices that endanger public health. Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda
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JobRx.com
5 takeaways from AP's report on the big backlog of uninspected drug factories As COVID-19 swept across the globe in early 2020, the Food and Drug Administration pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical plants in the U.S. and overseas. https://lnkd.in/guPHwXU5
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G2 Intelligence
Stay ahead of the curve with our latest quarterly Special Analysis report by Scott Wallask, which covers the FDA's final rule for laboratory-developed tests (LDTs). This report breaks down the key concerns and offers expert insights from industry leaders. Learn about the phased compliance requirements, how these changes could impact your lab operations, and answers to other frequently-asked questions about LDTs regulation. 👉 Read the full report here: https://lnkd.in/eQpjypVg #Healthcare #ClinicalLabs #FDA #LDTs #MedicalRegulations #LabTesting
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Microbac Laboratories, Inc.
Ever wondered what lies beyond your reports and data? Now that you’ve submitted your samples and have started to receive reports, take the time with Microbac Laboratories’ Corporate Senior Technical Director of Engagement and Consulting, Trevor Craig, to go through all the information on your report and understand your data. 📅 Date: May 30th 🕐 Time: 1:00 PM - 2:30 PM ET Don't miss out on this opportunity to elevate your understanding of your data and optimize your strategies. Register now to secure your FREE spot and gain the knowledge you need to excel! REGISTER HERE: https://lnkd.in/gxUydHWr #DataAnalysis #Webinar #ProfessionalDevelopment #MicrobacLaboratories
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