08
Jul

One Slip Can Really “Bug” You or Your Product, but Help is On the Way!

One unexpected outcome of the current global pandemic is that the world has received a crash course in basic microbiology.  Ask just about anyone, anywhere in the world today, and they can tell you that diseases such as Covid 19 are caused by an organism too small to see, that can be passed person to […]

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29
Jun

STILL TIME TO REGISTER FOR “REMOTE AND VIRTUAL INSPECTIONS DURING THE COVID-19 PANDEMIC: REGULATOR PERSPECTIVES”

Globally, the COVID-19 pandemic has required changes in the way regulators worldwide have been approaching the inspection of manufacturing facilities. Please join us for a webinar presented by PDA sponsored by Lachman Consultants titled “Remote and Virtual Inspections during the COVID-19 Pandemic: Regulator Perspectives” on June 29 from 10 am-11:30 AM EST to gain some […]

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24
Jun

“REMOTE AND VIRTUAL INSPECTIONS DURING THE COVID-19 PANDEMIC: REGULATOR PERSPECTIVES” – STILL TIME TO REGISTER!

Globally, the COVID-19 pandemic has required changes in the way regulators worldwide have been approaching the inspection of manufacturing facilities. Please join us for a webinar presented by PDA sponsored by Lachman Consultants titled “Remote and Virtual Inspections during the COVID-19 Pandemic: Regulator Perspectives” on June 29 from 10 am-11:30 AM EST to gain some […]

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18
Jun

Recording available for webinar on Virtual Inspections

Lachman Consultants recently participated in a webinar with Arnold & Porter called “FDA Inspection Alternatives During the COVID-19 Pandemic: Requesting, Preparing for and Responding to FDA Virtual Inspections”. If you missed it, don’t despair – there is a recording of it, which can be found here. We hope you enjoy it, and look forward to “seeing” you at […]

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17
Jun

Lachman Consultants to Sponsor PDA Webinar “Remote and Virtual Inspections during the COVID-19 Pandemic: Regulator Perspectives”

Globally, the COVID-19 pandemic has required changes in the way regulators worldwide have been approaching the inspection of manufacturing facilities. Please join us for a webinar presented by PDA sponsored by Lachman Consultants titled “Remote and Virtual Inspections during the COVID-19 Pandemic: Regulator Perspectives” on June 29 from 10 am-11:30 AM EST to gain some […]

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08
Jun

WEBINAR: FDA Inspection Alternatives During the COVID-19 Pandemic: Requesting, Preparing for and Responding to FDA Virtual Inspections

Due to COVID-19 travel and safety concerns, the Food and Drug Administration has suspended most of its foreign and domestic inspections. In order to avoid delays in evaluating applications to market drugs, devices and biologics because of the lack of an in-person inspection, FDA has recognized the need to rely on alternatives, such as virtual […]

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08
Jun

WEBINAR: FDA Inspection Alternatives During the COVID-19 Pandemic: Requesting, Preparing for and Responding to FDA Virtual Inspections

Due to COVID-19 travel and safety concerns, the Food and Drug Administration has suspended most of its foreign and domestic inspections. In order to avoid delays in evaluating applications to market drugs, devices and biologics because of the lack of an in-person inspection, FDA has recognized the need to rely on alternatives, such as virtual […]

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22
May

WHY YOUR QUALITY CULTURE MATTERS NOW MORE THAN EVER

Nothing is normal these days.   We’ve learned to be creative in everything we do during this crisis, from where and how we work, to finding scarce resources in both our work and personal lives.  Rules have changed to accommodate circumstances, and expectations have been colored by those changes.  Take for example FDA’s Emergency Use Authorization […]

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03
Apr

COVID-19 Devices in the Fast Lane – Help is Here!

Lachman Consultants recognizes the urgency of supporting the COVID-19 response efforts.  Companies may be adding additional personnel or expanding manufacturing resources to aid in producing life-saving medical equipment and supplies.  While COVID-19 is requiring non-essential personnel to stay home and stay safe, these teams are at the forefront.  We want to assure you that Lachman […]

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