All materials © 1994 to 2024 by Pharma Conference and J.W. Smith.
1995 | 1996 | 1997 | 1998 | 1999 | 2000 | 2001 | 2002 | 2003 | 2004 | 2005
| 2006 | 2007 | 2008 | 2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2021 | 2022|
2023 | 2024
1995
Strategies for Successful Management of FDA Issues
April 3 • Amsterdam, Netherlands
Surviving the Challenges of Current FDA Pharmaceutical Inspections
April 4-7 • Amsterdam, Netherlands
GMP On the River Walk
October 16-18 • San Antonio, TX
1996
Surviving the Challenges of Current FDA Pharmaceutical Inspections II
February 13-15 • Vienna, Austria
Surviving the Challenges of Current FDA Device Regulations
March 12-14 • Vienna, Austria
A 2 ½ Day Course in Advanced FDA Type Auditing for Pharmaceutical Personnel
August 7-9 • San Juan, Puerto Rico
GMP By The Sea
October 7-9 • Newport, RI
1997
Advanced FDA Type Auditing Techniques for Pharmaceutical Personnel
January 15-16 • Philadelphia, PA
Surviving the Challenges of Current FDA Pharmaceutical/Biotech Inspections III
February 10-13 • Vienna, Austria
USA vs. BARR Laboratories
June 12-13 • Dublin, Ireland
GMPs Today and Tomorrow
July 21-23 • Ft. Lauderdale, FL
GMP on the River Walk
September 8-10 • San Antonio, TX
2nd Annual GMP By The Sea
September 15-17 • Providence, RI
1998
FDA and the Changing Paradigm for Blood Regulation
January 14-16 • New Orleans, LA
Surviving the Challenges of Regulatory Authorities and Mutual Recognition
February 2-5 • Brussels, Belgium
Beyond the BARR Decision
March 20-April 1 • Marco Island, FL
3rd Annual GMP By The Sea
August 31-September 2 • Newport, RI
CME on the River Walk: The Cutting Edge of Clinical Practice
October 8-11 • San Antonio, TX
GMP On the River Walk III
October 14-16 • San Antonio, TX
1999
FDA and the Changing Paradigm for Blood Regulation II
January 13-15 • New Orleans, LA
GMP In The High Country: FDA and Medical Devices
January 19-21 • New Orleans, LA
Hot QA and Regulatory Issues for Transfusion Services
February 22-24 • San Antonio, TX
5th Annual Surviving the Challenges of Regulatory Authorities and Mutual Recognition
March 23-25 • Vienna, Austria
Beyond the BARR Decision: Its Impact on Drug GMPs
April 26-28 • Marco Island, FL
GMP 101: Basic GMP Training for Pharmaceutical Personnel
July 12-14 • Chicago, IL
4th Annual GMP By The Sea
August 30-September 1 • Newport, RI
FDA and the Current Challenges of GMPs, MRAs and Harmonization
November 17-19 • Philadelphia, PA
2000
3rd Annual FDA and the Changing Paradigm for Blood Regulation
January 19-21 • New Orleans, LA
GMP 101 for Pharmaceutical and Device Personnel & Auditing Pharmaceutical and Device Quality Operations
February 7-10 • San Juan, Puerto Rico
6th Annual Surviving the Challenges of Regulatory Authorities and Mutual Recognition
March 6-8 • Hamburg, Germany
FDA Operating Issues for Pharmaceuticals
March 9-10 • Hamburg, Germany
GMPs for Pharmaceutical and Device Personnel
May 22-23 • Parsippany, NJ
Auditing Pharmaceutical and Device Quality Operations
May 24-25 • Parsippany, NJ
FDA and Validation Management
June 19-21 • Koln, Germany
FDA and the Current Challenges of GMPs
August 7-9 • Mahwah, NJ
5th Annual GMP By The Sea
August 28-30 • Newport, RI
Advanced Technical GMP Training I
December 4-6 • Chicago, IL
2001
4th Annual FDA and the Changing Paradigm for Blood Regulation
January 17-19 • New Orleans, LA
Basic GMP Training for Pharmaceutical and Device Personnel
January 22-23 • New Orleans, LA
Surviving the Challenges of FDA and Other Regulatory Authorities’ GMPs
March 12-14 • Amsterdam, Netherlands
Meet the FDA and MCA in France
March 15-16 • Paris, France
cGMPs for Biotech Drug Products
April 2-3 • Scottsdale, AZ
Blood, FDA and GMPs: Understanding FDA’s GMP Expectations
April 5-6 • Las Vegas, NV
Auditing Quality and Safety in Blood Banking
June 4-5 • Las Vegas, NV
Dealing with OOS Results and Failure Investigations
June 7 • Las Vegas, NV
Communicating with the FDA
June 8 • Las Vegas, NV
6th Annual GMP By the Sea
August 27-29 • Hilton Head Island, SC
Updating Preparation for FDA Inspections
September 24-25 • Chicago, IL
Preparing for FDA and Euro Regulatory Expectations
October 22-24 • London, England
October 24-26 • Paris, France
2002
5th Annual FDA and the Changing Paradigm for Blood Regulation
January 16-18 • New Orleans, LA
cGMPs for Biotech Drug Products
February 25-26 • San Francisco, CA
March 11-12 • Orlando, FL
Blood, FDA and GMPs: Understanding FDA Expectations
March 14-15 • Las Vegas, NV
All About Quality: A Quality Management System for the Blood and Plasma Industry
April 16-18 • Las Vegas, NV
Current GMPs for The Pharmaceutical Industry
April 18-19 • Las Vegas, NV
8th Annual Surviving the Challenges of FDA and Other Regulatory Authorities’ GMPs
May 13-15 • Copenhagen, Denmark
May 15-17 • Manchester, England
Biopharmaceutical Inspections: Before, During and After – A How to Do it Right with FDA Inspections
June 6-7 • Baltimore, MD
4th Annual FDA and the Current Challenges of GMPs
August 5-7 • Princeton, NJ
7th Annual GMP By The Sea
August 26-28 • Hilton Head, SC
FDA and the Current Challenges of GMPs
November 13-15 • Berlin, Germany
Preparing for FDA Inspections – An Interactive Workshop
November 18-19 • Berlin, Germany
November 21-22 • Paris, France
2003
6th Annual FDA and the Changing Paradigm for Blood Regulation
January 15-17 • New Orleans, LA
Current GMPs For The Pharmaceutical Industry With FDA Experts
February 27-28 • Las Vegas, NV
Preparing for FDA Inspections: An Interactive Workshop
March 3-4 • San Francisco, CA
cGMPs for Biotech Drug Products
March 17-18 • San Diego, CA
9th Annual Surviving the Challenges of FDA and Other Regulatory Authorities’ GMPs
March 24-26 • Dublin, Ireland
March 26-28 • Basel, Switzerland
Blood, FDA and GMPs: Going Electronic – From Interview to Distribution
May 15-16 • Las Vegas, NV
5th Annual FDA and the Current Challenges of GMPs
July 28-30 • New Brunswick, NJ
8th Annual GMP By The Sea
August 25-27 • Cambridge, MD
Preparing for FDA Inspections
September and October in San Francisco, CA; Boston, MA; Orlando, FL; Washington DC; Chicago, IL
Preparing for FDA Inspections: An Interactive Workshop
October 27-28 • Boston, MA
FDA and the Current Challenges of GMPs – Europe
November 12-14 • Vienna, Austria
2004
7th Annual FDA and the Changing Paradigm for Blood Regulation
January 14-16 • New Orleans, LA
Current GMPs for the Pharmaceutical Industry with FDA Experts
February 19-20 • Las Vegas, NV
10th Annual Surviving the Challenges of FDA and Other Regulatory Authorities’ GMPs
March 22-24 • Basel, Switzerland
More Current GMPs for the Pharmaceutical Industry
April 26-27 • New Orleans, LA
Preparing for FDA Inspections: An Interactive Workshop
May 17-18 • San Diego, CA
Basic Training for Blood GMPs
May 20-21 • Dallas, TX
Blood, FDA and GMPs: Understanding FDA’s GMP Expectations
June 3-4 • Las Vegas, NV
6th Annual FDA and the Current Challenges of GMPs
August 2-4 • New Brunswick, NJ
Challenges to the Blood Supply and Recall Prevention and Reaction
August 11-12 • Dallas, TX
9th Annual GMP By The Sea
August 23-25 • Cambridge, MD
Current In-depth Cleaning Validation Issues
September 20-21 • Chicago, IL
Preparing for FDA Inspections: An Interactive Workshop
September 27-28 • Ft Lauderdale, FL
FDA and the Current Challenges of GMPS
October 25-26 • Munich, Germany
October 28-29 • London, England
2005
8th Annual FDA and the Changing Paradigm for Blood Regulation
January 19-21 • Las Vegas, NV
FDA and the New Paradigm for Tissue Regulation
February 1-3 • Dallas, TX
Current GMPs for the Pharmaceutical Industry with FDA Experts
February 17-18 • Las Vegas, NV
11th Annual Surviving the Challenges of FDA and Other Regulatory Authorities’ GMPs
March 14-16 • Prague, Czech Republic
More Current GMPs for the Pharmaceutical Industry
April 7-8 • Tampa, FL
Preparing for FDA Inspections: An Interactive Workshop
April 11-12 • Philadelphia, PA
Basic Training for Blood GMPs
April 19-20 • Dallas, TX
FDA Current In-Depth Cleaning Validation Issues
May 16-17 • Philadelphia, PA
June 6-7 • San Juan, Puerto Rico
4th Annual Blood, FDA and GMPs
June 23-24 • New Orleans, LA
GTP Workshops: Implementing the New Regulations and Preparing for FDA Inspections
June 27-29 • New Orleans, LA
7th Annual FDA and the Current Challenges of GMPs
July 25-27 • New Brunswick, NJ
10th Annual GMP By The Sea
August 29-31 • Cambridge, MD
FDA Current In-Depth Cleaning Validation Issues
September 29-30 • Dublin, Ireland
October 3-4 • Berlin, Germany
FDA and the Current Challenges of GMPs – Europe
October 5-7 • Berlin, Germany
Preparing for FDA Inspections: An Interactive Workshop
November 2-3 • Seattle, WA
In-Depth GMPs for Pharma and Biotech
December 7-9 • Las Vegas, NV
2006
9th Annual FDA and the Changing Paradigm for Blood Regulation
January 18-20 • Las Vegas, NV
In-Depth Cleaning Validation: Taking it to the Next Level
January 26-27 • Las Vegas, NV
2nd Annual FDA and the Changing Paradigm for Tissue Regulation
February 8-10 • Las Vegas, NV
Surviving the Challenges of Your First FDA Inspection
February 7 • Las Vegas, NV
Current GMPs for Pharmaceuticals and Biopharmaceuticals with FDA
February 7-8 • Las Vegas, NV
12th Annual Surviving the Challenges of FDA and Other Regulatory Authorities’ GMPs
April 4-6 • Rome, Italy
Regulation of Biologics and Biotechnology Products in the US and Europe
May 8-9 • McLean, VA
Explore Quality Systems GMPs for the Pharmaceutical and Device Industries with Ex-FDA Experts
June 14-15 • San Francisco, CA
8th Annual FDA and the Current Challenges of GMPs
July 24-26 • East Brunswick, NJ
11th Annual GMP By The Sea
August 28-30 • Cambridge, MD
A Joint FDA/URI Conference CDER on CMC: 21st Century Pharmaceutical Manufacturing and Control Strategies – A New Paradigm
October 17-18 • Reston, VA
2007
10th Annual FDA and the Changing Paradigm for Blood Regulation
January 10-12 • San Antonio, TX
Fundamentals of Tissue Regulation by FDA
January 23 • San Antonio, TX
3rd Annual FDA and the Changing Paradigm for HCT/P Regulation
January 24-26 • San Antonio, TX
Niche Tissues
January 26 • San Antonio, TX
Quality Systems for Pharmaceuticals/Biopharmaceuticals
February 7-8 • Jacksonville, FL
13th Annual Surviving the Challenges of FDA and Other Regulatory Authorities’ GMPs
March 26-28 • Barcelona, Spain
Current GMP Concepts: Common FDA 483 Observations and How to Avoid Them
April 16-17 • San Antonio, TX
Current GMP Concepts: Preparing for 21st Century FDA and European Agencies Inspections
June 5-6 • Bethesda, MD
Optimizing the Supervisory Role for GMP Compliance in Blood Banking
June 11-12 • Las Vegas, NV
Current GTP Concepts for HCT/Ps
June 14-15 • Las Vegas, NV
9th Annual FDA and the Current Challenges of GMPs
July 23-25 • New Brunswick, NJ
12th Annual GMP By The Sea
August 27-29 • Cambridge, MD
Current GMP Concepts: Preparing for 21st Century FDA and European Agencies Inspections
October 2-4 • Vienna, Austria
CDER on CMC: 21st Century Pharmaceutical Manufacturing and Control Strategies – A Changing Paradigm
October 15-16 • Bethesda, MD
Current GMP Concepts: Focus on Biologics
November 12-13 • San Antonio, TX
2008
4th Annual FDA and the Changing Paradigm for HCT/P Regulation
January 9-11 • San Antonio, TX
11th Annual FDA and the Changing Paradigm for Blood Regulation
January 16-18 • San Antonio, TX
Current GMP Concepts: Cleaning and Cleaning Validation Inspectional Trends
February 28-29 • Dublin, Ireland
Current GMP Concepts: Preparing for 21st Century FDA and European Agencies Inspections
March 3-5 • Vienna, Austria
Current GMP Concepts: Preparing for 21st Century FDA and European Agencies Inspections
April 9-10 • San Diego, CA
10th Annual FDA and the Current Challenges of GMPs
May 20-21 • New Brunswick, NJ
FDA and Generic Drugs An Interactive Forum
June 30-July 1 • Bethesda, MD
Timely Topics for FDA Regulated HCT/P Establishments
June 10-11 • Las Vegas, NV
13th Annual GMP By The Sea
August 25-27 • Cambridge, MD
3rd Annual CDER on CMC: 21st Century Pharmaceutical Manufacturing and Control Strategies – A Changing Paradigm
October 20-21 • Bethesda, MD
2009
12th Annual FDA and the Changing Paradigm for Blood Regulation
January 14-16 • Las Vegas, NV
5th Annual FDA and the Changing Paradigm for HCT/P Regulation
January 28-30 • Las Vegas, NV
FDA Issues in Vaccine Manufacturing
March 23-24 • Bethesda, MD
Preparing for and Managing FDA and EU Inspections
March 25-26 • Bethesda, MD
Auditing Your Pharmaceutical and Biopharmaceutical Operations
April 23-24 • Bethesda, MD
11th Annual FDA and the Current Challenges of GMPs
May 19-20 • New Brunswick, NJ
Quality Risk Management-Implementation Strategies
June 15-16 • Bethesda, MD
14th Annual GMP By The Sea
August 24-26 • Cambridge, MD
Preparing for and Managing FDA and EU Inspections
October 5-6 • Orlando, FL
21st Century Approaches to Pharmaceutical Manufacturing: Reducing Costs, Improving Compliance
October 7-8 • Orlando, FL
2010
13th Annual FDA and the Changing Paradigm for Blood Regulation
January 27-29 • Orlando, FL
6th Annual FDA and the Changing Paradigm for HCT/P Regulation
February 3-5 • Orlando, FL
FDA HCT/P Issues
February 2 • Orlando, FL
FDA and PAT for Pharma Manufacturing
May 11-12 • Bethesda, MD
12th Annual FDA and the Current Challenges of GMPs
May 18-19 • New Brunswick, NJ
Preparing for and Managing FDA and EU Inspections
June 10-11 • San Diego, CA
15th Annual GMP By The Sea
August 16-18 • Savannah, GA
2011
14th Annual FDA and the Changing Paradigm for Blood Regulation
January 31-February 1 • San Antonio, TX
FDA HCT/P Issues
February 2 • San Antonio, TX
7th Annual FDA and the Changing Paradigm for HCT/P Regulation
February 3-4 • San Antonio, TX
Operational Excellence: A Lifecycle Approach to Assuring Drug Quality
April 5-6 • Bethesda, MD
13th Annual FDA and the Current Challenges of GMPs
June 20-21 • Bethesda, MD
16th Annual GMP By The Sea
August 8-10 • Tampa, FL
2012
Introduction to HCT/Ps and cGMP/QS
January 23 • San Antonio, TX
8th Annual FDA and the Changing Paradigm for HCT/P Regulation
January 24-25 • San Antonio, TX
15th Annual FDA and the Changing Paradigm for Blood Regulation
January 26-27 • San Antonio, TX
14th Annual FDA and the Current Challenges of GMPs
May 7-8 • Bethesda, MD
17th Annual GMP By The Sea
August 8-10 • Tampa, FL
2013
16th Annual FDA and the Changing Paradigm for Blood Regulation
January 28-29 • San Antonio, TX
FDA and 483 Issues
January 30 • San Antonio, TX
9th Annual FDA and the Changing Paradigm for HCT/P Regulation
March 4-6 • Bethesda, MD
18th Annual GMP By The Sea
July 29-31 • Cambridge, MD
17th Annual Blood Conference: FDA and Current Issues in Blood Banking
January 27-28 • San Antonio, TX
10th Annual FDA and the Changing Paradigm for HCT/P Regulation
March 24-26 • Bethesda, MD
19th Annual GMP By The Sea
August 11-13 • Cambridge, MD
2015
11th Annual FDA and the Changing Paradigm for HCT/P Regulation
March 23-25 • Bethesda, MD
Preparing for FDA HCT/P Inspections
March 26 • Bethesda, MD
20th Annual GMP By The Sea
August 10-12 • Cambridge, MD
12th Annual FDA and the Changing Paradigm for HCT/P Regulation
February 24-26 • San Antonio, TX
Meeting the Challenges: FDA Inspections
April 12-13 • Morristown, NJ
Meeting the Challenges: FDA Inspections
July 19-20 • Vienna, Austria
21st Annual GMP By The Sea
August 29-31 • Cambridge, MD
13th Annual FDA and the Changing Paradigm for HCT/P Regulation
February 13-15 • Alexandria, VA
22nd Annual GMP By The Sea
August 28-30 • Cambridge, MD
14th Annual FDA and the Changing Paradigm for HCT/P Regulation
February 5-7 • Alexandria, VA
GMPs for Current Times
March 20-21 • San Diego, CA
23nd Annual GMP By The Sea
August 27-29 • Cambridge, MD
GMPs for Current Times
April 9-10 • Orlando, FL
15th Annual FDA and the Changing Paradigm for HCT/P Regulation
April 23-24 • Washington, DC
Advanced GMPs and Current Regulatory Issues with FDA and Other Regulatory Authorities
June 11-13 • Copenhagen, Denmark
24th Annual GMP By The Sea
August 12-14 • Cambridge, MD
16th Annual FDA and the Changing Paradigm for HCT/P Regulation
Virtual Conference
April 27-28, 2021
17th Annual FDA and the Changing Paradigm for HCT/P Regulation
April 12-13, 2022 • Cambridge, MD
26th Annual GMP By The Sea
August 15-17, 2022 • Cambridge, MD
Current Hot GMP Topics
(to help keep you out of trouble with the FDA)
February 8-9, 2023 • San Diego, CA
April 18-19, 2023 • Alexandria, VA
27th Annual GMP By The Sea
August 14-16, 2023 •
Cambridge, MD
19th Annual FDA and the Changing Paradigm for HCT/P Regulation
May 7-8, 2024 • Alexandria, VA
28th Annual GMP By The Sea
August 12-14, 2024 • Cambridge, MD
All materials © 1994 to 2024 by Pharma Conference and J.W. Smith
