July 21, 2005 Volume 1, Number 4
 
 

Good Times and Expanding Horizons in Pharmaceutical Manufacturing-By Jim Miller
Considerations for Outsourcing Laboratory Equipment Maintenance-By Martin Long
Outsourcing Outlook-Singapore Fling
Washington Report-FDA, Congress Push for Safer Drugs
Inside USP-US Pharmacopeia's International Activities
Contracts, Mergers, and Announcements
People
Calendar of Events
Contact Us
 
   


Calendar of Events
Industry Overview
Calendar of Events

August 2005

1–2:
Conducting Internal Audits, Research Triangle Park, NC. Contact: PTi international, PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

1–2:
Conducting Batch Record Reviews and Investigations, Las Vegas, NV. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

1–2:
Activated Carbon Short Courses, Seattle, WA. Contact: Barbara Sherman, PACS, Inc., 409 Meade Drive, Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, Barbpacs@aol.com, http://pacslabs.com

1–2:
Writing Standard Operating Procedures (SOPs), Washington, DC. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

1–3:
Gas Chromatography: Principles and Applications, Seattle, WA. Contact: Barbara Sherman, PACS, Inc., 409 Meade Drive, Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, Barbpacs@aol.com, http://pacslabs.com

3–4:
Stability Testing of Proteins, Peptides & Other Biomolecules, Irvine, CA. Contact: The Center for Professional Innovation & Education, 992 Old Eagle School Rd., Suite 913, Wayne, PA 19087, tel. 610.688.1708, fax 610.688.1708, info@cfpie.com, www.cfpie.com

3–4:
Complying with Computer and Software Validation Requirements, Boston, MA. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

3–4:
Cleanroom Microbiology for the Non-Microbiologist, Irvine, CA. Contact: The Center for Professional Innovation & Education, tel. 610.688.1708, fax 610.688.7817, www.cfpie.com

3–5:
Mass Spectral Interpretation: Intermediate, Seattle, WA. Contact: Barbara Sherman, PACS, Inc., 409 Meade Drive, Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, Barbpacs@aol.com, http://pacslabs.com

4–5:
Implementing Good Documentation Practices, Boston, MA. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

6:
Expert Witness Practices, Seattle, WA. Contact: Barbara Sherman, PACS, Inc., 409 Meade Drive, Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, Barbpacs@aol.com, http://pacslabs.com

8:
Maximizing SOPs – An Untapped Resource of Training Solutions, Baltimore, MD. Contact: Gail Sherman, PDA Global Headquarters, Suite 1500, 3 Bethesda Metro Center, Bethesda, MD 20814, tel. 410.455.5800, fax 301.986.0296, Sherman@pda.org, www.pda.org/calendar/courses/maximizing_SOPs

8–9:
Complying with FDA Requirements for Labeling and Packaging, St. Louis, MO. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

8–10:
Mass Spectral Interpretation: Advanced, Seattle, WA. Contact: Barbara Sherman, PACS, Inc., 409 Meade Drive, Coraopolis, PA 15108, tel. 724.457.6576 or 800.367.2587, fax 724.457.1214, Barbpacs@aol.com, http://pacslabs.com

9:
Introduction to Writing and Auditing cGMP Documentation, Baltimore, MD. Contact: Gail Sherman, PDA Global Headquarters, Suite 1500, 3 Bethesda Metro Center, Bethesda, MD 20814, tel. 410.455.5800, fax 301.986.0296, Sherman@pda.org, www.pda.org/cGMPdoc2005

11–12:
Writing in Regulated Environment when English is Your Second Language, Irvine, CA. Contact: The Center for Professional Innovation & Education, tel. 610.688.1708, fax 610.688.7817, info@cfpie.com, www.cfpie.com

11–12:
Introduction to Good Manufacturing Practices (GMPs), Boston, MA. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

15–16:
Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA), Morristown, NJ. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

15–16:
Writing Reports for Failure Investigations and Process Deviations, Irvine, CA. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

15–16:
QA/QC Statistics for Non-Statisticians, San Francisco, CA. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

15–16:
Mastering Your Performance as a QA Professional, San Juan, Puerto Rico. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

15–17:
Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries, Irvine, CA. Contact: The Center for Professional Innovation & Education, tel. 610.688.1708, fax 610.688.7817, www.cfpie.com

15–19:
Pharmaceutical Engineering and Manufacturing Programs for Practicing Pharmaceutical Professionals, West Lafayette, IN. Contact: Barb Tyner, OCEC Business Services, Purdue University, Stewart Center, Room 110, 128 Memorial Mall, West Lafayette, IN 47907-2034, tel. 765.494.2975 or 800.359.2968, fax 765.496.6384, bgt@purdue.edu, www.purdue.edu/dp/ptec

16–17:
Preparing the CMC Section for NDA's/IND's/CTD's, Irvine, CA. Contact: The Center for Professional Innovation & Education, tel. 610.688.1708, fax 610.688.7817, info@cfpie.com, www.cfpie.com

16–17:
Implementing Good Documentation Practices, San Francisco, CA. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

16–17:
Implementing Key Requirements for Process Validation, San Juan, Puerto Rico. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

16–17:
Managing Non-Conformances and Complaints, Chicago, IL. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

16–19:
Computer Systems Software Validation, San Francisco, CA. Contact: Institute of Validation Technology, PO Box 6004, Duluth, MN 55806-6004, tel. 888.524.9922 or 218.723.9130, fax: 218.723.9308, registration@ivthome.com, www.ivthome.com

17–18:
Complying with GMPs for Clinical Manufacturing, Las Vegas, NV. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

17–19:
Hands-On Tableting Technology, Norristown, PA. Contact: Emerson Science Center, 600 Markley St., Norristown, PA 19401, tel. 610.279.7450, fax 610.292.9722, www.emersonsciencecenter.com

18–19:
Complying with FDA/ICH Requirements for Stability Testing, Philadelphia, PA. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

22–23:
Biotechnology - Biochemical Principles and Techniques, Malvern, PA. Contact: The Center for Professional Innovation & Education, tel. 610.688.1708, fax 610.688.7817, www.cfpie.com

22–23:
Biotechnology - Biochemical Principles and Techniques, Malvern, PA. Contact: The Center for Professional Innovation & Education, tel. 610.688.1708, fax 610.688.7817, info@cfpie.com, www.cfpie.com

22–23:
Auditing and Qualifying Suppliers and Vendors, Philadelphia, PA. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

22–26 and 8/19–8/23:
Aseptic Processing Training Program, Baltimore, MD. Contact: Gail Sherman, PDA Global Headquarters, Suite 1500, 3 Bethesda Metro Center, Bethesda, MD 20814, tel. 410.455.5800, fax 301.986.0296, Sherman@pda.org, www.pda.org/ap05

23–24:
Complying with Chemistry Manufacturing and Controls (CMC) Requirements, Toronto, ON, Canada. Contact: PTi international, P.O. Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

23–24:
Introduction to Good Manufacturing Practices (GMPs), Princeton, NJ. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

24–26:
Introduction to Molecular Biology Techniques - Applications in Biotechnology and the Pharmaceutical Industry, Malvern, PA. Contact: The Center for Professional Innovation & Education, tel. 610.688.1708, fax 610.688.7817, info@cfpie.com, www.cfpie.com

24–26:
FDA Regulatory and Compliance Symposium, Cambridge, MA. Contact: PharmaAudioconference Office, 7790 Barberry Ave., Yucca Valley, CA 92284, fax 760.418.8084, www.FDASymposium.com

24–26:
Molecular Biology and Genetic Engineering, Malvern, PA. Contact: The Center for Professional Innovation & Education, tel. 610.688.1708, fax 610.688.7817, www.cfpie.com

24–26:
Managing Risks – From Pipeline to Patient, Cambridge, MA. Contact: FDA Symposium Office, 7790 Barberry Ave., Yucca Valley, CA, tel. 800.684.4549, registration@hcconferences.com, www.FDASymposium.com

24–26:
FDA Regulatory and Compliance Symposium, Cambridge, MA. Contact: FDA Symposium Office, 7790 Barberry Ave., Yucca Valley, CA 92284, tel. 800.684.4549, registration@hcconferences.com, www.FDASymposium.com

25–26:
The Analysis and Characterization of Protein Therapeutic Drug Products, Wyndam Washington, DC. Contact: American Chemical Society, 1155 Sixteenth St., Washington DC 20036, tel. 800.227.5558 ext. 4508 or 202.872.4508, fax 202.872.6336, www.chemistry.org/shortcourses

25–26:
Complying with FDA/ICH Requirements for Stability Testing, San Francisco, CA. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

25-26:
Successful Process Chemistry and Scale-up for Drug Manufacturing, Washington, DC. Contact:www.chemistry.org/shortcourses

25-26:
Organic Chemistry of Drug Design and Drug Action, Washington, DC. Contact: American Chemical Society, 1155 Sixteenth St., Washington DC 20036, tel. 800.227.5558 ext. 4508 or 202.872.4508, fax 202.872.6336, www.chemistry.org/shortcourses

25-27:
Pharmacology for Chemists, Wyndam Washington, DC. Contact: American Chemical Society, 1155 Sixteenth St., Washington DC 20036, tel. 800.227.5558 ext. 4508 or 202.872.4508, fax 202.872.6336, www.chemistry.org/shortcourses

26-27:
Practical Capillary Electrophoresis, Washington, DC. Contact: American Chemical Society, 1155 Sixteenth St., Washington DC 20036, tel. 800.227.5558 ext. 4508 or 202.872.4508, fax 202.872.6336, www.chemistry.org/shortcourses

26-27:
Computational Chemistry and Computer-Assisted Drug Design: Practical Approaches, Washington, DC. Contact: American Chemical Society, 1155 Sixteenth St., Washington DC 20036, tel. 800.227.5558 ext. 4508 or 202.872.4508, fax 202.872.6336, www.chemistry.org/shortcourses

26-27:
Genomics and Proteomics: From Recombinant DNA Technology to Current Techniques, Washington, DC. Contact: American Chemical Society, 1155 Sixteenth St., Washington DC 20036, tel. 800.227.5558 ext. 4508 or 202.872.4508, fax 202.872.6336, www.chemistry.org/shortcourses

26-27:
Peptide and Protein Characterization with Mass Spectrometry, Washington, DC. Contact: American Chemical Society, 1155 Sixteenth St., Washington DC 20036, tel. 800.227.5558 ext. 4508 or 202.872.4508, fax 202.872.6336, www.chemistry.org/shortcourses

28-31:
ACS National Exposition, Washington, DC. Contact: American Chemical Society-National Expositions, 1155 Sixteenth St., Washington DC 20036, tel. 202.872.4486, fax 202.872.4410, expo@acs.org, www.chemistry.org/expositions

29–30:
Complmying with Chemistry Manufacturing and Controls (CMC) Requirements, San Francisco, CA. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com

30–31:
Complying with Computer and Software Validation Requirements, Princeton, NJ. Contact: PTi international,
PO Box 3685, Boston, MA 02241, tel. 866.647.0921 or 941.951.7885, fax 941.365.2507, register@pti-international.com, www.pti-international.com
 
For a comprehensive listing, please vist the Pharmaceutical Technology website, or click here. (continued to Contact Us)

 

 


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