June 10, 2005 Volume 1, Number 3
 
 

Investing Time to Make Money: A PAT Implementation Perspective-By John E. Carroll
API Scale-Up During Research and Development-By Nandita P. Shetgiri, Mahesh S. Phansalkar, Sandeep Patil, and Rupesh Kelaskar
Outsourcing Outlook-Seeking a Fresh Start
Packaging Forum-New Systems for Counterfeit Protection and Quality Control
Washington Report-Drug Specifications Under Scrutiny
Contracts, Mergers, and Announcements
People
Calendar
Contact
 
   


Calendar
Industry Overview
Calendar

July 2005
11–12: The EU Clinical Trial Directives, Malvern, PA. Contact: The Center for Professional Innovation & Education, 992 Old Eagle School Rd., Suite 913, Wayne, PA 19087, tel. 610.688.1708, info@cfpie.com, http://cfpie.com

13
14: European Filing and Registration Procedures, Malvern, PA. Contact: The Center for Professional Innovation and Education, 992 Old Eagle School Rd., Suite 913, Wayne, PA 19087, tel. 610.688.1708, info@cfpie.com, http://cfpie.com

19
20: Computer System Validation in FDA-Regulated Industries, Alexandria, VA. Contact: Validation Associates, Inc., 305 E. Pennsylvania Blvd., Feasterville, PA 19053-7846, tel. 215.354.1720 ext. 201, fax 215.354.1725, info@validassoc.com, www.validassoc.com

20
21: 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, http://cfpie.com

August 2005
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, http://cfpie.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
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

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

September 2005
6
9: Advanced Environmental Mycology Identification Workshop, Baltimore, MD. Contact: Parenteral Drug Association, 3 Bethesda Metro Center, Suite 1500, Bethesda, MD 20814, tel. 301.986.0293, fax 301.986.0296, info@pda.org, www.pda.org

12
14: Good Laboratory Practices, Malvern, PA. 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, http://cfpie.com

15
16: Assay Validation for Pharmaceutical & Biopharmaceutical Quality Control, Malvern, PA. 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, http://cfpie.com

15
16: 14th Sampling, On-Site Analysis and Sample Preparation Conference, Pittsburgh, PA. Contact: PACS, Inc., 409 Meade Drive, Coraopolis, PA 15108, tel. 800.367.2587, fax 724.457.1214, hnpacs@aol.com, www.pacslabs.com

26–28: Pack Expo 2005, Las Vegas, NV. Contact: Packaging Machinery Manufacturers Institute, 4350 N. Fairfax Dr., Suite 600, Arlington, VA 22203, tel. 703.243.8555, 888.275.7664, fax 703.243.8556, expo@pmmi.org, http://pelv2005.packexpo.com

26–28: Pharmaceutical Manufacturing 2005, Dusseldorf, Germany. Contact: Hannah Reading, tel. 44.207.368.9400, hannah10@wbr.co.uk, www.pharma-man.com

27–29: Frontline Solutions Conference & Expo, Chicago, IL. Contact: Affect Strategies, Inc., 37 West 37th Street, 12th Floor, New York, NY 10018, tel. 212.398.9680, fax 212.504.8211, www.affectstrategies.com

27–30: USP Annual Scientific Meeting, San Diego, CA. Contact: US Pharmacopeia, 12601 Twinbrook Pkwy, Rockville, MD 20852, tel. 301.816.8134, fax 301.816.8148, www.usp.org/conferences

October 2005
6–7: 16th International Activated Carbon Conference, Pittsburgh, PA. Contact: PACS, Inc., 409 Meade Drive, Coraopolis, PA 15108, tel. 800.367.2587, fax 724.457.1214, hnpacs@aol.com, www.pacslabs.com

6
7: FDA Inspections—What to Expect and How to Prepare, Malvern, PA. 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, http://cfpie.com

11: Preparing Your QC & Analytical Development Labs For An FDA Inspection, Malvern, PA. 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,
http://cfpie.com

24
25: 16th Annual International Light Scattering Colloquium, Four Seasons Biltmore Hotel, Santa Barbara, CA. Contact: Wyatt Technology Corporation, Santa Barbara, CA, www.wyatt.com

24
26: Process R&D Summit, Philadelphia, PA. Contact: Carol Dinerstein, Cambridge Health Institute, 1037 Chestnut Street, Newton Upper Falls, MA 01760, tel. 617.630.1371, dinerstein@healthtech.com, www.ProcessSummit.com

November 2005
6–10: 2005 AAPS Annual Meeting and Exposition, Nashville, TN. Contact: American Association of Pharmaceutical Scientists, 2107 Wilson Blvd, Suite 700, Arlington, VA 22201-3042, tel. 703.243.2800, fax 703.243.9650, www.aapspharmaceutica.com

7
9: Reporting Failure Investigations and Process Deviations, Malvern, PA. 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, http://cfpie.com

8
9: Writing Effective Standard Operating Procedures and Other Process Documents, Malvern, PA. 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, http://cfpie.com

December 2005
5
6: Protein Chromatography—From Analytical Methods Development to Downstream Purification, Malvern, PA. 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, http://cfpie.com

7
8: BioManufacturing of Protein Therapeutics: Rewards and Challenges, Malvern, PA. 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, http://cfpie.com

8
9: Preparing the CMC Section for NDA’s/IND’s/CTD’s, Malvern, PA. 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, http://cfpie.com (continued to Contact) 

 

 


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