enKap community

Engaged. Knowledge. Application

FDA is emphasising on training needs. Once the API starting material is introduced into the API process, GMP controls are increased according to some reasonable and scientifically sound rational as processing proceeds from early process steps to final synthesis, isolation and purification steps. Of course, the degree of control depends on the process and manufacturing stage. And in the same way it goes for training too. In the initial steps if the training is not very detailed the effects in case of deviations do not cause a serious problem. But as we move on to final stages workmen error can have vast consequences. Training and Education are one of the best preventive and responsive investments a firm can take. Training should be an integral and fundamental thread that holds the success of a firms programs together to assure conformance to the standards. Training programs reflect current practices and procedures.Keep abreast of what others may be doing.80 % of logged deviations may be recorded as human error. Tackling the deviations for corrective and preventive measures is time and money consuming in the long run

Views: 0

Comment

You need to be a member of enKap community to add comments!

Join enKap community

Contact enKap

Phone: +1-561-308-3093

To e-mail enKap - click here

125 South State Road 7, Suite 104-222, Wellington, Fl, 33414, U.S.A.

Members

  • Suzanne Carlson
  • Janet Wilson
  • Tala Davidson
  • Li Ma
  • madhu Julakanti
  • Catherine Akelo-Opio

enKap Terms and Conditions


enKap Terms and Conditions

All sales are final

Legal Disclaimer

This product and any of its enclosures, attachments or appendices, references to online information, conferences or preparations of materials in a variety of formats are created to provide you with accurate and authorative information concerning the subject matter covered. However, this product and any other ancillary items disseminated in connec-
tion with same are not necessarily prepared by a person licensed to practice law in a particular jurisdiction.
enKap, Inc. is not engaged in rendering legal advice, and this product is not a substitute for the advice of an attorney. If you require legal or other expert advice, you should seek
the services of a competent attorney or other professional.
enKap, Inc. necessarily is not, cannot and will not be liable for any claims, damages, or regulatory legal proceedings initiated as a consequence of you, the customer, modifying,
altering, adding to or deleting portions of any product initially provided by enKap, Inc.
Once any original document provided by enKap, Inc. to you, whether in print or electronic format, has been manipulated or customized by you, then the responsibility for the
document’s accuracy, correctness, and compliance are solely yours.
If any action, claim for damages, or regulatory proceedings is commenced against enKap, Inc. as a consequence of your alteration or modification, etc. of the document templates
or other originally provided materials, then and in that event, you agree to indemnify enKap, Inc. for such claims, and for any attorney’s fees expended by enKap, Inc. in connec-
tion with defense of same.


© copyright 2010 enKap



© 2012   Created by enKap.

Badges  |  Report an Issue  |  Terms of Service