quality-one
25th December 2007, 10:13 AM
Dear All
Hello again:)
I would like train chemistry and chemical eng.students and need some advice from you concerning the details, examples, applications that might come across those students when they have completed their education.:confused:
I have completed a detailed presentation but need extra examples, problems that might occur, forms, instructions.
Where should I look at ?
Thanks in advance:(
Stijloor
25th December 2007, 10:26 AM
Dear All
Hello again:)
I would like train chemistry and chemical eng.students and need some advice from you concerning the details, examples, applications that might come across those students when they have completed their education.:confused:
I have completed a detailed presentation but need extra examples, problems that might occur, forms, instructions.
Where should I look at ?
Thanks in advance:(
Hello Quality-One,
A few questions:
What level of education have these students completed?
What ISO 9001:2000-related topics are you looking for in particular?
Stijloor.
harry
25th December 2007, 10:29 AM
In a way, ISO 9001 is about good business practices. For Chemistry/Chemical Engineering, work around 'Good Laboratory Practices' and see how good practices can aid or break a business. With regards to GLP, I think you know it better than us. ;) ;)
Ajit Basrur
25th December 2007, 10:56 AM
Totally agree with Harry.
For Chemistry aspects, refer to FDA's 21 CFR Part 58 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58) for more details.
You could also have a look at Environmental Protection Agency (EPA)'s Quality System - Quality Management Tools - Best Practices for Laboratory Quality Systems (http://www.epa.gov/quality/bestlabs.html) and has couple of training materials too :)
harry
25th December 2007, 11:34 AM
In addition, you may want to look at the following documents for further clarification and guidance.
ISO 9001:2000 CEFIC Guidelines for use by the chemical industry (http://www.cefic.be/files/Publications/ISO.CEFIC.PDF)
ISO 9001 Guidelines for the Chemical and Process Industries, 3rd ... (http://www.techstreet.com/cgi-bin/detail?product_id=925835)
Stijloor
25th December 2007, 11:37 AM
In addition to Harry's and Qualityalways' excellent contributions, attached is a document titled: "ISO 9001:2000 CEFIC Guidelines for use by the chemical industry" published by the European Chemical Industry Council. The initial intent was to help this industry with the transition from ISO 9001:1994 to ISO 9001:2000. Aside from that, it contains excellent "pointers" how (some of) the requirements apply to the chemical industry.
Stijloor.
Added comment: Oops, I noticed that Harry already provided a link to this document.
quality-one
25th December 2007, 01:27 PM
Hey My Dear Friends
Thanks a lot
I appreciate it believe me.
You have done me a great favour
:applause::applause:
:agree:
Ajit Basrur
25th December 2007, 09:16 PM
Thanks Harry and Stijloor. :applause::applause::applause:
I didnot know of the CEFIC document on ISO 9001 :agree1:
Weiner Dog
26th December 2007, 09:28 PM
Dear All
Hello again:)
I would like train chemistry and chemical eng.students and need some advice from you concerning the details, examples, applications that might come across those students when they have completed their education.:confused:
I have completed a detailed presentation but need extra examples, problems that might occur, forms, instructions.
Where should I look at ?
Thanks in advance:(
Besides the ISO standards and FDA laws and regs, introduce the students to the actual materials noted in these standards, laws, and regs.
For example:
Depending upon the country, many human pharmaceuticals, some medical devices, and some device operations (such as sterilization) have to comply with that country's official National Formulary, or Pharmacopeia, or any supplement to them. (I did not know this until I worked as an analyst for the FDA.)