FAQ: If I have only 2-3 years experience in Quality can I pass the exam.?

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

quote>

Answer: CSQA tests your ability to handle practical situations mainly in subjective questions.

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

If you have hands-on experience for 2-3 years in Quality you should be able to clear the exam. If you have just

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

started in quality then it is upto your individual ability which you can determine after reading some questions

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

on this site. The pre-requisite of the exam is that you have atleast 1 year of experience in Quality.

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

te>

• All the exam information can be found at www.softwarecertifications.org about the EXAM , procedures

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

, how to Apply and materials.

• Oultine of Certified Software Quality Analysts (CSQA) Prep

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

uide ( earlier name CBOK ) can be found at http://www.softwarecertifications.org/csqabok/csqabok.htm or http://w

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ww.softwarecertifications.org/csqabok/CSQACBOK2006.pdf.

• You can purchase the book at
  tions increase the patient compliance?
  What would be the developing cost?
  How to tackle the risks encountered during combination product developmen
  arget="_new" href="http://www.qaiworldwide.org/bookstore">http://www.qaiworldwide.org/bookstore. Member & No
  t?
  
  As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
  member price: $100 each ~ Hard Copy / $60 each ~ CD
• If you signup

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

and pay $350. You will recieve CD as it is included in the price after you have been accepted.

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ockquote>Note: You do NOT have to select the exam date while applying. You have one year's time

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

after your candidacy is accepted to choose exam date. Its recommended that you signup after you feel comfortable

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

about the preparing on time.

For more information visit CSQA.info

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products