From owner-diagnostics@net.bio.net Wed Oct 02 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.diagnostics Subject: BIOSCI/bionet miniFAQ & Fundraiser Date: 3 Oct 1996 06:33:16 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 239 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <530fas$ki1@net.bio.net> NNTP-Posting-Host: net.bio.net (LAST REVISION: 30-JUL-95) This BIOSCI "miniFAQ" is designed to answer the questions that come up the *most frequently*. The main BIOSCI FAQ (Frequently Asked Questions) is accessible on the World Wide Web at URL http://www.bio.net/. If you can not find an answer to your question in this or other documentation, the BIOSCI technical support staff answers e-mail queries sent to biosci-help@net.bio.net We can only answer questions about the use of the newsgroups and mailing lists. We unfortunately do not have the staff to do Internet information searches or answer scientific questions. Please post those to the appropriate BIOSCI/bionet newsgroups. Contents: -------- 0) BIOSCI NEEDS YOUR SUPPORT!! 1) Using the WWW to access the BIOSCI/bionet newsgroups. 2) What to do about "spams," i.e., junk mail, ads, etc. 3) Examples of subscribing and unsubscribing to the mailing lists. 4) The BIOSCI user address and research interest directory. 0) BIOSCI NEEDS YOUR SUPPORT!! ------------------------------ BIOSCI's government funding has been expended, and we are now operating solely from advertising revenue that we have raised from our Web site at http://www.bio.net/. We need just a few minutes of your time to help us serve you. You can do two important things which will take very little time for you individually and will immensely help us continue to help you. First, please use our WWW system at http://www.bio.net/ to access the archives. You can post or reply to messages via your Web browser as described in item #1 below. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. 1) Using the WWW to access the BIOSCI/bionet newsgroups. -------------------------------------------------------- As of 10 December 1995, all BIOSCI/bionet full newsgroups are accessible through the World Wide Web (WWW) at URL http://www.bio.net. One can read and reply publicly or privately to both recent postings and archived messages through one's Web browser if it is configured properly to send e-mail. Each newsgroup is equipped with its own WAIS index. The main BIOSCI home page also has access to the BIO-JOURNALS Table of Contents database WAIS index and the BIOSCI user address database described in another item further below. 2) What to do about "spams," i.e., junk mail, ads, etc. ------------------------------------------------------- BIOSCI is a set of parallel USENET newsgroups (the "bionet" groups), mailing lists, and a hypermail archive at URL http://www.bio.net/. The same postings are distributed on all media (except for a small number of mailing-list-only groups at net.bio.net). Unfortunately it is becoming a despicable practice on the Internet (by a few people out to make a fast buck) to do automated mass postings to thousands of newsgroups and mailing lists. These attempts to grab free advertising are refered to as "spams" in the usual, somewhat boneheaded, net terminology. USENET is more susceptible to this practice, and many spams originate on the USENET groups and then are passed on to the mailing lists. However, spammers also get lists of mailing addresses and hit these too, so neither medium is immune. What should you do personally if you get junk mail? --------------------------------------------------- Just delete it and move on without reading it further. Filing a protest is becoming increasingly useless because spammers are often disguising the addresses where the messages are sent from. Unless you really understand Internet mail systems, your attempt at protest by sending replies to the message will often end up being sent to the address of an innocent person that the spammer is victimizing. What can BIOSCI/bionet do to protect its newsgroups? ---------------------------------------------------- The only solution currently available is to moderate the newsgroup. If this newsgroup is already moderated, then you are in good shape. Moderation protects the USENET distribution from about 95% of the spams that are being sent to date and protects the mailing lists completely. Moderation means, however, that someone has to take the time to review each message before it goes out. We have set up software here that simply allows the moderator to forward to an address at net.bio.net messages that (s)he wishes to have distributed. This takes no more time than that needed to read the message and pass it on, say about 1 min. per message. Most newsgroups currently have a discussion leader who is responsible for their newsgroup. The discussions leaders and their e-mail addresses are listed in the BIOSCI Information Sheet which is available on the Web at http://www.bio.net/. If a newsgroup is being hit with too many junk postings, please contact the discussion leader for that group and see if there is interest in moderating the group. Please do not assume that by simply posting a complaint to the newsgroup itself, anyone on the BIOSCI staff will act on your complaint. With close to 100 newsgroups to run, the BIOSCI staff has to rely on the discussion leaders of each newsgroup to report problems directly to us at biosci-help@net.bio.net. We will moderate any of our newsgroups if the discussion leader tells us that the readership of the group wishes to do so and if a moderator is willing to do the work. For most BIOSCI/bionet groups, this entails only a few minutes of work each day. Moderating a newsgroup will resolve probably 95% of the junk postings on the USENET distribution. Unfortunately there are easy ways for determined spammers to override the moderation mechanism on USENET, but we can protect our e-mail subscribers from unwanted postings if the newsgroup is moderated. You can also access our newsgroups over the WWW at URL http://www.bio.net. While this Web interface will not stop spammers from trying to post to the groups, this will give you yet another way, besides using USENET news, to keep the junk out of your personal mail files. For those of you with local USENET news systems, the Web interface will also give you faster access to new newsgroups and recent postings. 3) Examples of subscribing and unsubscribing to the mailing lists. ------------------------------------------------------------------ PLEASE NOTE: The BIOSCI management does NOT act on subscription/unsubscription requests that are posted improperly to the newsgroups and mailing lists. People who do this only bother everyone on the lists to no avail. Please be sure to follow the proper procedures below. Gory details are in the BIOSCI Information sheets on the Web at http://www.bio.net. Below we give an example utilizing the METHODS-AND-REAGENTS list at both of our two BIOSCI sites: Users in the Americas and Pacific Rim countries who use the BIOSCI ------------------------------------------------------------------ node at computer net.bio.net: ---------------------------- A) Determine the "listname" which is the <=8 character mail address ^^^^^^^^^^^^^ for the group. These can be found in the BIOSCI Info. Sheet. For the METHODS-AND-REAGENTS group the mailing address is methods@net.bio.net. The listname is the portion of the address to the left of the @ sign, i.e., "methods". The listname is used with the "subscribe" and "unsubscribe" commands illustrated below. B) Mail all commands in the body of a mail message addressed to biosci-server@net.bio.net. Do NOT send commands to the newsgroup posting addresses! Leave the Subject: line blank, any text on it will be ignored. C) In the body of your message put one or more of the following commands with an "end" command on the last line, e.g., subscribe methods unsubscribe methods end Do NOT put your e-mail address or other text on these lines. The server only allows you to cancel your subscription if the address on your mail header matches the address on our mailing list. Please ask for help at biosci-help@net.bio.net if your address has changed, e.g., if you know you are on the list but the server tells you that you are not a member. Users in Europe, Africa, and Central Asia who use the BIOSCI node at -------------------------------------------------------------------- computer daresbury.ac.uk (also known as dl.ac.uk): ------------------------------------------------- To subscribe and unsubscribe to/from the BIOSCI lists, you need to specify the full USENET newsgroup name with "bionet-news." prepended. The USENET newsgroup names are listed in the BIOSCI Information sheet on the Web at http://www.bio.net/. For the METHODS-AND-REAGENTS list the USENET newsgroup name is bionet.molbio.methds-reagnts, thus the appropriate commands are sub bionet-news.bionet.molbio.methds-reagnts unsub bionet-news.bionet.molbio.methds-reagnts These commands are included in a message addressed to mxt@dl.ac.uk, NOT to the newsgroup mailing addresses. As usual, include the text in the body of the message as text on the Subject: line is ignored. To unsubscribe from all the lists at the UK node, use unsub bionet-news Please note that if the address in the list is different than the one in your mail message header, you will not be able to unsubscribe by this method. If you have problems, please mail biosci@daresbury.ac.uk. 4) The BIOSCI user address and research interest directory. ----------------------------------------------------------- Please take this opportunity to add your name, address, and research interest information to the BIOSCI User Address Database if you have not already done so. You can fill out the address form directly through our Web page at URL http://www.bio.net/adrform.html. The address database is reindexed nightly for WWW access (the URL is http://www.bio.net/). If you are not directly on the Internet but can reach it by e-mail, please use our waismail server to access the user directory. waismail use is described above. You can also request a user address form by e-mail from biosci-help@net.bio.net. Please check your database entry from time-to-time to see if your address information is still up-to-date. Because of our limited personnel resources, we ask that you resubmit a *complete* form to revise your entry; we only replace complete entries and do not have resources to edit old forms. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net From owner-diagnostics@net.bio.net Thu Oct 03 23:00:00 1996 Path: biosci!biosci!not-for-mail From: DKRowayton Newsgroups: bionet.diagnostics Subject: Director of Immunology Position Available - Reston, VA Date: 4 Oct 1996 05:19:14 -0700 Organization: America Online, Inc. (1-800-827-6364) Lines: 29 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <532vc2$lko@net.bio.net> NNTP-Posting-Host: net.bio.net I apologize for this intrusion, but if you or any of your colleagues in this field know of an MD who might interested and qualified, we are anxiously seeking to fill a Board Certified MD position in a research facility in Reston, VA, just outside Washiington, DC. The candidate must be Board Certified in Immunology and at least 5 years out of school. The position is for Director of Immunology- a resident guru in the Immunology Testing area. The selected individual will also be set up so that she or he can also have their own private practice. The salary will be approximately $150K plus income from the individual's practice. Free office space will be provided. I am with Higbee Associates, Inc., a prestigious Executive Search firm based in Connecticut, with over 20 years of specialized experience.For complete information regarding this unique opportunity, please e-mail me at: dkrowayton@aol.com If you personally are not interested in this opportunity, would you please advise on how to find an MD to fill the above position, who to contact, etc. Again, I apologize for this unsolicited communication, and thank you for any assistance you may offer in locating our special immunologist. Thank you. Dick Katzman HIGBEE ASSOCIATES, INC. From owner-diagnostics@net.bio.net Thu Oct 03 23:00:00 1996 Path: biosci!biosci!not-for-mail From: "Peter Scott(Dir Info Inst)" Newsgroups: bionet.diagnostics Subject: BSPP Presidential Conference, Canterbury, UK December 1996 Date: 4 Oct 1996 05:19:14 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 75 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <532vc2$lkm@net.bio.net> NNTP-Posting-Host: net.bio.net To: Kevin O'Donnell I'm preparing my Presidential Address for the British Society for Plant Pathology's December Conference in Canterbury, and I'd be glad of ideas from a wide range of people. The title is "THE INCREDIBLE PACE OF CHANGE - INFORMATION TECHNOLOGY IN SUPPORT OF PLANT PATHOLOGY". My plan was to range over the following topics, with some demonstrations. (For amplification of the topics, see the papers that have been invited under these or similar headings at http://www.bspp.org.uk/dec96con.htm). 1. Handling facts to produce information - Handling the information explosion in plant pathology. Data management: bibliographic; nomenclatural; molecular; etc. 2. Interpreting information to produce knowledge - Taxonomic Information Systems; Geographic Information Systems; Multimedia; etc. 3. Using knowledge to support decision making - Modelling epidemics; Diagnostic tools; Expert Systems for disease management; etc. 4. Using knowledge to make predictions - Epidemic forecasting; Risk analysis 5. Passing on knowledge in education and training - New media; Interactive training; Distance learning; etc. 6. Storing and disseminating information - Intranets, the Internet, World Wide Web; Electronic publishing; MPPOL (see http://www.bspp.org.uk/mppol) ; Opportunities for developing countries. In any of these areas, or any others, PLEASE SHARE YOUR IDEAS WITH ME AND OTHERS by e-mailing to bspplist@bbsrc.ac.uk. Include some or all of this message in your e-mail if it helps. The new technology gives us a remarkable opportunity to start the Conference well ahead of time, and to hit the ground running when we get to Canterbury (16-19 December)! If you want to share in this ongoing e-mail discussion and you haven't yet joined the BSPPLIST Discussion Group, there's one simple job to do first. Send an e-mail containing only the word SUBSCRIBE (don't include a subject heading) to bspplist-REQUEST@bbsrc.ac.uk. Then you will automatically receive other people's messages sent to bspplist@bbsrc.ac.uk. If later you want to leave the discussion, send an e-mail containing only the word UNSUBSCRIBE (don't include a subject heading) to bspplist-REQUEST@bbsrc.ac.uk. Some of the recipients of this message are responsible for other Internet Discussion Groups or Web sites. Please feel free to post this message or information about the Conference as you think fit. Please distribute information about the Conference as widely as you like. Everyone is welcome. Please book early to be sure! Peter -- Peter Scott Director, Information Institute, CAB INTERNATIONAL, Wallingford OX10 8DE, UK Tel: +44 1491 832111. Fax: +44 1491 833508 President, British Society for Plant Pathology Work: p.scott@cabi.org http://www.cabi.org Home: peter@scottp.demon.co.uk BSPP: http://www.bspp.org.uk ********************************************************************** Information Technology in Plant Pathology and Systematics BSPP/SA Meeting, University of Kent, 16-19 December 1996 SEE INTERACTIVE PROGRAMME AT http://www.bspp.org.uk/dec96con.htm ********************************************************************** From owner-diagnostics@net.bio.net Mon Oct 07 23:00:00 1996 Path: biosci!biosci!not-for-mail From: lmcgrath@foothill.net Newsgroups: bionet.diagnostics Subject: Product Choices Date: 8 Oct 1996 01:40:58 -0700 Organization: Foothill Net Lines: 4 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <53d42q$1lt@net.bio.net> NNTP-Posting-Host: net.bio.net We are looking for feedback about Genzyme vs. R&D Systems' cytokine assays. Which product perform better and why. Any information out there would be greatly appreciated. Thanks! larel From owner-diagnostics@net.bio.net Mon Oct 07 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Guy.Cotton@news1.belgium.eu.net, LSD Newsgroups: bionet.diagnostics Subject: Gamma rays and sterilisation (B) Date: 8 Oct 1996 01:39:11 -0700 Organization: EUnet Belgium, Leuven, Belgium Lines: 25 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <53d3vf$1ik@net.bio.net> NNTP-Posting-Host: net.bio.net Gamma rays and sterilisation (B) -------------------------------- I'm a dental surgeon and I send again this mail. I hope I will receive more answers and more precisions. I want to ask to the Specialists some questions: are the Gamma rays sterilize all the bacteriae and viruses ? One application is the Gamma's use for dental implants who are inserted in the maxillary bones. Do you think that Gamma rays will give all securities about sterilization? Wich dose will be like the best ? And this dose during how many time ? I hope you will give fundamental answers and all references as possible who will confirm the real effects of the Gamma rays. Please, answer on my private E-mail, undermentioned. Thank you very much and have a good day! Guy Cotton, LSD. (from Liege, in Belgium) Any question or suggestion or opinion will be appreciated on the SMTP From owner-diagnostics@net.bio.net Tue Oct 08 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Bryan Kiehl Newsgroups: bionet.diagnostics Subject: ISO and Human Diagnostic Assays Date: 9 Oct 1996 01:47:40 -0700 Organization: GenBio Lines: 19 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <53forc$n3g@net.bio.net> NNTP-Posting-Host: net.bio.net I work in a medium size company that makes immunoassays for both the US and European markets. In most cases we sell these through various distributors. We comply with GMP and GLP, but have only been monitoring the ISO regs. At this time, it is my understanding that ISO does not apply to most diagnostic kits. I would be interested in various comments about the following subjects: CE marks; can they be established without ISO registration ISO as it relates to in vitro diagnostics Any other related issues. -- Bryan Kiehl GenBio, San Diego GenBio@msn.com From owner-diagnostics@net.bio.net Tue Oct 08 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Juan Pablo Martinez-Soriano Newsgroups: bionet.diagnostics Subject: International Course on Plant Genome Manipulation Date: 9 Oct 1996 01:45:20 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 88 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <53fon0$m6f@net.bio.net> NNTP-Posting-Host: net.bio.net INTERNATIONAL COURSE (First announcement) "Analysis and Manipulation of the Plant Genome" Centro de Investigacion y de Estudios Avanzados (CINVESTAV) Irapuato, Mexico. March 10-21, l997 Please see: http://ccr.dsi.uanl.mx/~jpmtz/plant.html --------------------------------------------------------------------------- Sponsors: United Nations University (Biolac Program)/UNESCO Biotechnology Action Council/ International Cell Research Organization/ International Society for Plant Molecular Biology/ National Research and Technology Council (Mexico). OBJECTIVES - To present and discuss the structure, dynamics and expression of the plant genome. - To increase and improve scientific capabilities in Latin America and the Caribbean region in the different molecular and cellular techniques that facilitate the study and manipulation of the plant genome. The practical part of the course will focus on important regional crops, including maiz, potato, papaya, etc. - To foster regional collaboration, coordination and information exchange. COURSE CONTENT The experimental part of the course will cover the following techniques: -In situ hybridization -Two hybrid yeast system. -Use of AFLP for gene mapping and fingerprinting -Production and purification of plant proteins in E. coli. -Differential mRNA display. -PCR based detection of plant pathogens. -Biolistic transformation of plant cells Language: English. All participants are expected to be fluent in English to be able to actively participate in all lectures. Host Institution: Centro de Investigacion y de Estudios Avanzados. Unidad Irapuato, Irapuato, Mexico Participants: Twenty participants will be accepted, of which 14 will be from outside Mexico. No registration fee will be charged, The organizers will provide full board and lodging to the selected participants. Applicants are strongly urged to obtain travel grants from their own institutions or governments. If funds are available a limited number of travel grants will be provided. Applications should be received by December 15, l996 and should include the following: -Name and address. -Telephone, fax, telex and electronic mail address. -Bio-data INCLUDING educational and research experience, and a list of published research paper. -Other courses and meetings attended during the past five years. -A statement of reasons for, and benefits from, attending the course. -Letter of recommendation from a senior scientist familiar with the applicant's research. -Amount of support available and additional resources needed. Applications and all correspondence should be sent to: Dr. Luis Herrera-Estrella CINVESTAV-Unidad Irapuato Apartado postal 629 Km. 9.6 libramiento Norte carretera Irapuato-Leon 36500 Irapuato, Gto. Mexico Tel. (52-462) 5 16 00; Fax. (52-462) 5 12 82; Applications can be submitted by e-mail to the following address: curso97@irapuato.ira.cinvestav.mx Applicants will be informed of their selection by January 31, l997. From owner-diagnostics@net.bio.net Thu Oct 10 23:00:00 1996 Path: biosci!biosci!not-for-mail From: MHughes77@aol.com Newsgroups: bionet.diagnostics Subject: Re: ISO and Human Diagnostic Assays Date: 11 Oct 1996 01:49:23 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 30 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <53l1mj$lte@net.bio.net> NNTP-Posting-Host: net.bio.net I am very interested in receiving the comments by newsgroup members on this topic too. Please post replies publicly to the newsgroup (diagnost@net.bio.net). Thanks, Mark Hughes RapidTest Diagnostics International, Inc. ********************************** In a message dated 96-10-09, Bryan Kiehl wrote: > I work in a medium size company that makes immunoassays for both the US and > European markets. In most cases we sell these through various distributors. > > We comply with GMP and GLP, but have only been monitoring the ISO regs. At > this time, it is my understanding that ISO does not apply to most > diagnostic kits. > > I would be interested in various comments about the following subjects: > > CE marks; can they be established without ISO registration > > ISO as it relates to in vitro diagnostics > > Any other related issues. From owner-diagnostics@net.bio.net Sun Oct 13 23:00:00 1996 Path: biosci!biosci!not-for-mail From: "J. H. MACKENZIE" <100023.3435@compuserve.com> Newsgroups: bionet.diagnostics Subject: ISO and Human Diagnostic Assays Date: 14 Oct 1996 03:18:19 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 45 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <53t41b$2ve@net.bio.net> NNTP-Posting-Host: net.bio.net --------------- Forwarded Message --------------- From: J. H. MACKENZIE, 100023,3435 To: Bryan Kiehl, INTERNET:GenBio@cts.com Date: Wed, Oct 9, 1996, 17:35 RE: ISO and Human Diagnostic Assays I am a consultant specialising in Quality and regulatory matters in the medical devices and in vitro diagnostics field. To answer your questions 1. ISO 9000 is a general quality systems standard and does not apply to any products but to systems. EN 46000 is for the application of ISO to medical devices. 2. A new European Directive is being prepared which will apply to all IVD's sold in Europe. This will entail CE marking of products. ISO registration may or may not be necessary depending on the class of IVD. In my opinion it will be the best route. 3. There will be so called Harmonised Standards which will apply to IVD's. 4. I could write pages on this subject but I hope you appreciate that I make my living by advising companies such as yours on this subject. regards Jim Mackenzie. * * * * ********* ********* LONG LANE, * * * * * * HAWTHORN HILL, * * * * * * MAIDENHEAD, * * * * ********* BERKSHIRE, * * * * ENGLAND, U.K. * * * * TEL/FAX (44) 01628 - 782537 * * ********* ********* email:100023,3435@COMPUSERVE.COM "INSTRUMENTAL IN QUALITY IMPROVEMENT" From owner-diagnostics@net.bio.net Sun Oct 13 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Richard Schifreen Newsgroups: bionet.diagnostics Subject: Re: ISO and Human Diagnostic Assays Date: 14 Oct 1996 04:00:01 -0700 Organization: DIGEX Lines: 35 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <53t6fh$5fl@net.bio.net> NNTP-Posting-Host: net.bio.net My reading of the proposed new device cGMP's is that they incorporate some of the ISO regs - especially in the area of design controls. This is part of the "harmonization" as the FDA and its equivalents in the European community move toward more unified regulations. Rich Schifreen rschifre@access.digex.net On 9 Oct 1996, Bryan Kiehl wrote: > > I work in a medium size company that makes immunoassays for both the US and > European markets. In most cases we sell these through various distributors. > > We comply with GMP and GLP, but have only been monitoring the ISO regs. At > this time, it is my understanding that ISO does not apply to most > diagnostic kits. > > I would be interested in various comments about the following subjects: > > CE marks; can they be established without ISO registration > > ISO as it relates to in vitro diagnostics > > Any other related issues. > -- > Bryan Kiehl > GenBio, San Diego > GenBio@msn.com > > --MAA00454.845292559/agricola.sasa.gov.uk-- From owner-diagnostics@net.bio.net Sun Oct 13 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Richard Schifreen Newsgroups: bionet.diagnostics Subject: Re: ISO and Human Diagnostic Assays Date: 14 Oct 1996 06:24:20 -0700 Organization: DIGEX Lines: 32 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <53teu4$jf3@net.bio.net> NNTP-Posting-Host: net.bio.net My reading of the proposed new device cGMP's is that they incorporate some of the ISO regs - especially in the area of design controls. This is part of the "harmonization" as the FDA and its equivalents in the European community move toward more unified regulations. Rich Schifreen rschifre@access.digex.net On 9 Oct 1996, Bryan Kiehl wrote: > > I work in a medium size company that makes immunoassays for both the US and > European markets. In most cases we sell these through various distributors. > > We comply with GMP and GLP, but have only been monitoring the ISO regs. At > this time, it is my understanding that ISO does not apply to most > diagnostic kits. > > I would be interested in various comments about the following subjects: > > CE marks; can they be established without ISO registration > > ISO as it relates to in vitro diagnostics > > Any other related issues. > -- > Bryan Kiehl > GenBio, San Diego > GenBio@msn.com > > From owner-diagnostics@net.bio.net Mon Oct 14 23:00:00 1996 Path: biosci!biosci!not-for-mail From: ResearchD Newsgroups: bionet.diagnostics Subject: Re: ISO and Human Diagnostic Assays Date: 15 Oct 1996 01:41:01 -0700 Organization: America Online, Inc. (1-800-827-6364) Lines: 29 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <53vimt$oge@net.bio.net> NNTP-Posting-Host: net.bio.net IS9001 seems to be the standard for production/design of medical devices (including in vitro diagnostics). ISO 9002 pertains more to manufacture only of in vitro biologics. I believe if you have any deisgn criteria you need ISO9001. In USA you still need to comply with GMP (which will incoporate most of the ISO requirements but not all). For European sales, you will need ISO registration before long. Many USA based firms are also "requesting" ISO registration before they will buy bulk OEM material or finished devices for export. FDA regulation will always be more stringent and a better overall indicator than ISO . ISO is a paperwork trail audited by paid consultants/auditors. There are many different auditors and you will find many different interpretations of these new regulations. You may wish to enguage a USA based consultant before starting the process. I am told you better expect to pay $20-30K to obtain registration assuming you already have evrything well documented (FDA GMP X 10). I know of one auditor you may wish to contact for an initial reveiw: Don Cox, Goldmark Biologicals,NJ phone 908-859-2631 see his web site: http://members.aol.com/goldmarker Sincerely, Bret G Wien Research Diagnostics Inc web: http://www.researchd.com From owner-diagnostics@net.bio.net Mon Oct 14 23:00:00 1996 Path: biosci!biosci!not-for-mail From: "J. H. MACKENZIE" <100023.3435@compuserve.com> Newsgroups: bionet.diagnostics Subject: Re: ISO and Human Diagnostic Assays Date: 15 Oct 1996 09:22:53 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 8 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <540dot$b74@net.bio.net> NNTP-Posting-Host: net.bio.net ISO registration in Europe will not be compusory but a full quality system including design will for certain products when the EU IVD medical devices directive comes into force. I am a UK based consultant currently helping several IVD companies achieve ISO 9001 and EN 46001 ON A WORLD WIDE BASIS Jim Mackenzie From owner-diagnostics@net.bio.net Mon Oct 14 23:00:00 1996 Path: biosci!biosci!not-for-mail From: mn.mlab@med.tmd.ac.jp Newsgroups: bionet.diagnostics Subject: [Announce] The Internet Survey of Morphological Laboratory Tests-1996A Date: 15 Oct 1996 01:46:31 -0700 Organization: Tokyo Medical and Dental University TMD Lines: 26 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <53vj17$otv@net.bio.net> NNTP-Posting-Host: net.bio.net Announcement of the Internet Survey of Morphological Laboratory Tests-1996A Everyone interested in laboratory medicine or clinical pathology are invited to join the survey project for quality assurance of laboratory tests, this time, with no entry charge. This controlled survey includes morphology on urinary examination, hematology and microbiology, and all procedures are done through the internet. Please check the home page at the address shown below. (Both Japanese and English are used there, so neglect queer characters other than English if you do not understand Japanese language) URL http://202.242.169.152/clap/survey.html (select 'the Internet Survey of Morphological Laboratory Tests-1996A' from the survey list shown there) by: The volunteer group for the internet activity of Japanese Association of Clinical Laboratory Physicians ------------------------------------------------------------------------ from: M. NISHIBORI, M.D., Clinical Laboratory Physician (No.269) Tokyo Ikashika University E-mail: mn.mlab@med.tmd.ac.jp From owner-diagnostics@net.bio.net Mon Oct 14 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Maarten de Bruijn Newsgroups: bionet.diagnostics Subject: veterinary diagnostics Date: 15 Oct 1996 01:44:28 -0700 Organization: Materia Medica International Limited Lines: 13 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <53vitc$oid@net.bio.net> NNTP-Posting-Host: net.bio.net Can anyone point me to information sources, on or off the net, on diagnostic kits available or in development for diagnosis of diseases in horses and agricultural animals (cattle, sheep, pigs). Thanks in advance for your help. Maarten -- Dr Maarten de Bruijn matmed@mdbspc.demon.co.uk 19 Belmont Avenue Macclesfield "The whole of science is nothing more than a Cheshire SK10 3JN, UK refinement of everyday thinking" (Albert Einstein) From owner-diagnostics@net.bio.net Tue Oct 15 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Frederic Bourgaud Newsgroups: bionet.diagnostics Subject: ergotamine Date: 16 Oct 1996 07:20:34 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 17 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <542qvi$mm6@net.bio.net> NNTP-Posting-Host: net.bio.net Hello netters, Does anyone out there know about a ready-to-use ELISA kit for ergotamine detection ? Thanks to all Frederic Bourgaud | ENSAIA-INRA | | Laboratoire Agronomie et Environnement | | 2, Avenue de la Foret de Haye voice (33) 83 59 58 64 | | 54500, Vandoeuvre fax (33) 83 59 57 99 | | France E-mail bourgaud@ensaia.u-nancy.fr | From owner-diagnostics@net.bio.net Tue Oct 15 23:00:00 1996 Path: biosci!biosci!not-for-mail From: "Frank S. Zollmann" Newsgroups: bionet.diagnostics Subject: HUM-MOLGEN Clinical Research WWW Date: 16 Oct 1996 01:41:07 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 39 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <542733$l1j@net.bio.net> NNTP-Posting-Host: net.bio.net Starting today (October 15), the DIAG section of HUM-MOLGEN is available on our WWW site at http://www.informatik.uni-rostock.de/HUM-MOLGEN/ Just click on "Clinical Research". As a courtesy to persons who already sent messages to DIAG, all postings which appeared in 1996 have been appended and will remain until the end of the year. Beginning January 1, 1997, messages will be deleted 3 months after the posting date. The same policy of DIAG will be applied to the web version. We believe this new service will increase the quality and value of the Human Molecular Genetics Network. Carlo Gambacorti MD Editor, for HUM-MOLGEN Clinical Research: This section contains requests from researchers or patients regarding: collaborative studies, shipment of samples, list of laboratories performing certain molecular tests, general information on diseases / treatments. ********************************************************************** +--------------------------------------------------------------------+ | | | HUM-MOLGEN - Internet Communication Forum in Human Genetics | | | | E-mail: HUM-MOLGEN@nic.surfnet.nl | | WWW: http://www.informatik.uni-rostock.de/HUM-MOLGEN/ | | | | Phone: 020-566 4598 (The Netherlands), (206) 386-2101 (USA) | | Fax: 020-691 6521 (The Netherlands), (206) 386-2555 (USA) | | | +--------------------------------------------------------------------+ From owner-diagnostics@net.bio.net Sun Oct 20 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Harold Pogue Newsgroups: bionet.diagnostics Subject: US-Boston Area-Medical Blood Chemistry Analyzers - several positions Date: 21 Oct 1996 08:35:28 -0700 Organization: UltraNet Communications, Inc. Lines: 59 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <54g580$72f@net.bio.net> NNTP-Posting-Host: net.bio.net Nova Biomedical, ISO 9001 certified, is a world leader in developing and manufacturing medical instrumentation. We have the following position openings in Waltham, Massachusetts. LAB TECH 4 To formulate and test solutions on Nova analyzers. Proper use of documentation such as AP's, TP's and OI's, DHR accuracy, record keeping and equipment maintenance. Must have good GMP skills. Requires: B.S. Medical Technology or equivalent experience and good lab and G.L.P. skills. SENIOR DEVELOPMENT SCIENTIST To assist chemistry manager and supervise chemists in the development of clinical analyzers employing state-of-art biosensors. Requires: 3-5 years hands-on experience in instrument development and problem solving; good supervisory and communication skills. Advanced degree in chemistry and system knowledge a plus. CLINICAL APPLICATIONS SPECIALIST To support Customer Support, Technical Service Support, R & D and Marketing Support. Responsibilities include support of evaluation sites for clinical trials, resolution of application-specific problems, training, correlation's, linearity and precision studies; site visits, aid in resolution of field issues, selection and implementation of beta site testing of new products. Provide support as an in-house resource on clinical questions/problems for hotline staff. Requires: Ph.D., 7-10 years Clinical Lab experience including lab management, instrumentation and evaluation experience, Quality Control studies; spectrophotometric systems and electrochemistry. INSIDE SALES REPRESENTATIVES If you're ambitious and sales oriented, we'll provide excellent training to start you on an exciting sales career. You'll contact prospects, qualify interest, make phone presentations, and work as part of a team to develop sales. Prior experience in sales preferred but not necessary. Salary and commissions. PRODUCT DEVELOPMENT PROGRAM MANAGER To manage multidisciplinary teams in the development of medical diagnostic products employing biosensors. Includes scheduling, budgeting and day-to-day technical supervision of ME's, EE's, software engineers and chemists. Requires advanced degree in chemistry and 3-5 years experience managing projects from concept development to product roll-out. Please send/fax resume to: Nova Biomedical Attn: Human Resources 200 Prospect Street Waltham, MA 02254 Fax 617-899-6259 From owner-diagnostics@net.bio.net Sun Oct 20 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Leclipteux Newsgroups: bionet.diagnostics Subject: Gold conjugation Date: 21 Oct 1996 04:29:26 -0700 Organization: Liege University Lines: 5 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <54fmqm$9id@net.bio.net> NNTP-Posting-Host: net.bio.net In order to perform immunohistochemistry experiments, I would like to conjugate monoclonals to gold particules. Information is rather difficult to obtain. Is there any possibility to get practical info with the net ? Thanks to reply by e-mail. From owner-diagnostics@net.bio.net Sun Oct 20 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Michael Yoon Newsgroups: bionet.diagnostics Subject: Immunoassay Development Scientist position at Bayer Date: 21 Oct 1996 02:02:21 -0700 Organization: Yoon and Associates Lines: 57 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <54fe6t$pmv@net.bio.net> NNTP-Posting-Host: net.bio.net Bayer Corporation Job Opportunities Open Position Notice An Equal Opportunity Employer EXTERNAL JOB POSTING Bayer Corporation a worldwide industrial leader in Pharmaceuticals, BiM=FF=FF=FF=FF=FF=FF=FF=FFnsumer Care, Diagnostics, Agriculture, Polymer= s, Fibers, Organics, Rubber, Industrial Chemicals and Photo Chemistry products has a= career opportunity at it's 43 acre campus like setting in Berkeley, California. If you're interested in a career at a stable, well funded organization co= nsider the following position: Position Title: Sr./Associate Research Scientist Local Posting No.: E96-157 Salary Grade: M07 Salary Range For M07: $43-80,000/yearly Location: Berkeley Shift/Hours: Dayshift Division: Pharmaceuticals Department: Clinical Chemistry Brief Description: Under limited supervision, performs and maintains investigational activities within the confines of defined research progra= ms and objectives. Executes assigned duties in complian e with G.L.P. Qualifications: Requires knowledge ordinarily acquired from the highest undergraduate level courses in Biology or medical lab sciences, plus 6+ y= ears of experience in immunoassay development, or an quivalent combination of education and experience. Special Skills: The clinical chemistry lab unit has been relocated to Berk= eley, CA, resulting in the opening of several positions. The incumbent in this posit= ion will be responsible for development f immunologically based assays required for compound development. This position will provide technical assay support for biological drug candidates including Bay x1351, 10-3356 ICAM and Kogenate. Specific skills required include protein isolation and purification. Experience in antibody modification highly desirable. Resumes: May be sent to*: Bayer Corporation Human Resources, MJY, E96-157ap P.O. Box 1986 Berkeley, CA 94701 * Please be sure to include the complete address From owner-diagnostics@net.bio.net Sun Oct 20 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Maarten de Bruijn Newsgroups: bionet.diagnostics Subject: Re: veterinary diagnostics Date: 21 Oct 1996 02:03:22 -0700 Organization: Materia Medica International Limited Lines: 12 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <54fe8q$pqg@net.bio.net> NNTP-Posting-Host: net.bio.net In article <53vitc$oid@net.bio.net>, Maarten de Bruijn writes >Can anyone point me to information sources, on or off the net, on >diagnostic kits available or in development for diagnosis of diseases in >horses and agricultural animals (cattle, sheep, pigs). Thank you for your useful email replies. Maarten -- Dr Maarten de Bruijn matmed@mdbspc.demon.co.uk 19 Belmont Avenue Macclesfield "An expert is someone who has stopped thinking. Cheshire SK10 3JN, UK Why should he? He is an expert" (Frank Lloyd Wright) From owner-diagnostics@net.bio.net Tue Oct 22 23:00:00 1996 Path: biosci!biosci!not-for-mail From: Karl Whitney Newsgroups: bionet.diagnostics Subject: help finding glutamate receptor antibody Date: 23 Oct 1996 07:17:59 -0700 Organization: Duke University, Durham, NC, USA Lines: 3 Sender: daemon@net.bio.net Approved: odonnell@sasa.gov.uk Distribution: world Message-ID: <54l9en$3p@net.bio.net> NNTP-Posting-Host: net.bio.net I am trying to find a glutamate receptor antibody directed against extracellular epitopes. Ideally this would be monoclonal and directed at GluR3. Can anyone suggest sources?