If you are a student, employee, or part of the military, you’ve probably experienced the frustration of not being able to access certain websites or even your webmail. Fortunately there are some things you can do to access these blocked sites. Here’s how…
Biological products often represent the cutting edge of medical science and research. Also known as biologics, these products replicate natural substances such as enzymes, antibodies, or hormones in our bodies.
Biological products can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues. Biologics are made from a variety of natural resources—human, animal, and microorganism—and may be produced by biotechnology methods.
What biological products does FDA regulate?
The Center for Biologics Evaluation and Research (CBER) within FDA regulates a wide range of biological products, including
- allergenic extracts (e.g. for allergy shots and tests)
- blood and blood components
- gene therapy products
- devices and test kits
- human tissue and cellular products used in transplantation
Communication has come a long way.It is a set of standards of acceptable behaviour you need to follow when online, and includes rules you need to follow while sending and receiving formal business missives.
Why do you need netiquette?
For two reasons:
- It creates an impression of professionalism and
- It ensures the correct message gets across.
And are the few questions that needed to kept in mind
1. Why are you writing to me?
State the purpose of your e-mail — it is a good practice to have a subject line that explains what follows and how high on the priority list it should be.
This information has to be in two places:
- The subject box, which is part of the compose e-mail form. Here, state the reason for your mail. If you are writing it to apply for leave, you could say ‘Leave application’.
- Subject line in the main e-mail body; just as you would in any formal business letter. Here, you could say:
Sub: Leave application, April 1-April 15 2006
2. Greet me right
Address people you don’t know as Mr, Mrs, Ms or Dr. Address someone by first name only if you are on a first name basis with each other; it is okay, under these circumstances, to use first names on a formal business missive.
If you do not know the name of the person, or whether it is a man or a woman, it is best to address the person concerned as: Dear Sir / Madam, Whomsoever it may concern, The Manager; etc.
3, And your point is?
Get to the point.
Verbosity and extreme terseness are two ends of a spectrum, you should try for the middle — state your point without sounding rudely brief or chatty.
3. 2 use or not 2 use…
Never use ‘sms-ese’ or informal abbreviations in your email. U instead of you, 2 instead of to or too, plz instead of please, thanx instead of thanks and 4 instead of for are a strict no-no.
While are all right for personal e-mail, they show a level of informality not encouraged in formal business communication. Frequently used abbreviations you may use include FYI (for your information), Pvt., Ltd., Co., etc., OK.
4. The magic of spells
Though using a spell check is a must, don’t rely on it completely. The most common areas of errors and confusion are — two, too and to.
Wrong: I would like two order too other books two.
Correct: I would like to order two other books, too.
5. Write right
Good grammar is very important. A correctly framed sentence, with proper punctuation in place, is what you should aim at. Be very careful with commas, especially, as they change the meaning of a sentence.
A good example would be:
Wrong: All foreign tea, tree, oils are free from duty.
Correct: All foreign tea tree oils are free from duty.
6. Mind your P’s and Q’s
Though a friendly tone is encouraged, basic corporate etiquette rules do apply. So, maintain a well-mannered, friendly polite stance.
Gender-neutral language is politically correct — couch your e-mail accordingly. This essentially means you should not assume a person’s gender on the basis of the designation. Keep the e-mail neutral.
7. Attachment breeds detachment
With worms, viruses, and spam, nobody wants to open attachments anymore, not even if the e-mail is from one’s own mother. If you do need to send an attachment, confirm this with the recipient first.
8. The KISS rules
Keep It Short and Simple. Use simple sentences, words that don’t need a dictionary. Use universal formats — not all systems support HTML rich style, or tables and tabs. You could lose much by way of appearances if your recipient’s system can’t support all that fancy formatting you spent hours working on.
9. Smile please
Smileys and other emoticons are a way to add ‘body language’ to e-mail. When used appropriately and sparingly, smileys do bring a touch of personalisation to otherwise impersonal mail. Of course, due care with regards to the appropriateness of the communication must be taken.
You would not use emoticons in job application covering letters, while delivering bad news (delay in order, loss of job, etc). Use discretion.
Emoticons are generally used to add comfort to the communication or soften the blow. The most common smiley faces are probably these:
🙂 OR 🙂 Just a smile / can be used for greeting or making a point gently.
😦 OR 😦 To show mild displeasure or that something is not going the way you want it to.
😉 Equivalent to a wink — used to convey that a particular comment is a joke and not to be taken too seriously.
;-> To be used sparingly, and with people you know well, as this signifies a provocative comment.
After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit.
To provide the facility with its own written list of discrepancies noted during the inspection, FDA developed form FDA 483, “Notice of Inspectional Observations,” issued by the field investigator.
Form 483 should contain only those observations that can be directly linked to a violation of regulations—not suggestions, guidance, or other comments. Although the 483 does not contain references to the regulations, each observation should be directly traceable to a section of the applicable regulations.
Items placed on a form 483 are the opinion of the FDA investigator on the scene, and may be subject to review by others within FDA. Current FDA policy requires that the agency write a follow-up letter to clinical investigators and IRBs. When the items on the 483 are confirmed in that letter, they may be taken as an official FDA position. Conversely, there is no guarantee that the follow-up letter will be limited to the items listed on the 483, as additional review by FDA headquarters may identify significant regulatory violations that were not listed on the 483, which will be included in the follow-up letter.
Nevertheless, this does not mean that a 483 should be ignored. A recipient of a 483 should promptly respond to FDA. An effective response addresses each item, indicating agreement and either providing a timeline for correction or requesting clarification of what FDA requires.
Source: Applied Clinical Trials Online
After years of resistance to a global accounting overhaul, American companies are rapidly coming around to the idea of adopting international financial reporting standards, a new Deloitte survey of finance executives suggests.
Polling executives at 200 companies, Deloitte found that 30 percent of CFOs and other finance officials would consider adopting IFRS within the next three years if given the option by the Securities and Exchange Commission.
The SEC’s decision to accept IFRS filings from foreign companies, and its signaling that the principles-based standards used in much of the world are likely to take hold here, were factors in the change, the accountancy suggested. Now, U.S. firms are busy considering what this will mean for them.