(A) Title of the Invention: (See 37 CFR 1.72(a).) This is pretty obvious - the title will be at the beginning of the specification. Many years ago, patents had very short, very generic titles - "Tool", "Device". Today, titles are longer and more specific, especially in patent ...
Additionally, LabArchives makes it easy to access, edit, and save many file types – along with version histories – while working within your ELN. Integrations: How easily can you integrate your existing research tools? Your ELN should work seamlessly with the tools and software you already ...
End-of-phase 1 (EOP1) meetings are formalPDUFA Type B meetingsheld between IND sponsors and CDER or CBER. Only biologics to treat serious or life- threatening illnesses (21 CFR 312 subpart E) and drugs under accelerated approval for serious/life threatening illnesses (21 CFR 314 subpart H)...
It simply is not enough to show empathy. To have impact, you need to take it to the next step which is action. Too many leaders will say, “I feel your pain” and then move onward. The compassionate leader will take the time to understand the other person’s issues/challenges/problems...
There are many details associated with a cGMP system that have not been addressed here. Sonneborn's Petrolia, PA manufacturing facility has been audited many times by our Pharmaceutical customers and on a regular basis by the FDA with very good results. Using a continuous improvement philosophy...
sciences industry. Many organizations with very robust QMSs routinely find themselves in a state of disarray and facing compliance issues when key members of the quality leadership team leave the organization. During one stretch in 2017, five of the 15 scheduled audits that I performed had leadershi...
"I know Google is a thing but didn't have much luck there. I need to convert some ISOs to MKV files but don't really want to have to pay for the software. Yes, I'm a cheap bastard." As an archive file of an optical disc, an ISO image file contains all written contents from ...
What are some of the biggest misconceptions authors have when it comes to book publicity? Many people feel book publicity is not quantifiable. I disagree with that notion. We can absolutely quantify the effects of publicity. When book publicity works, we see an increase in sales. Today, we ...
sciences industry. Many organizations with very robust QMSs routinely find themselves in a state of disarray and facing compliance issues when key members of the quality leadership team leave the organization. During one stretch in 2017, five of the 15 scheduled audits that I performed had leadershi...
sciences industry. Many organizations with very robust QMSs routinely find themselves in a state of disarray and facing compliance issues when key members of the quality leadership team leave the organization. During one stretch in 2017, five of the 15 scheduled audits that I performed had leadershi...