All materials © 1994 to 2017 by Pharma Conference and J.W. Smith

1995 | 1996 | 1997 | 19981999 | 20002001 | 20022003 | 2004
2005 | 20062007 | 2008 2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 20162017

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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2014
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

Auditing Pharmaceutical and Biotechnology Drug Product Systems for Business and Regulatory Compliance
June 15-16 • Bethesda, MD

20th Annual GMP By The Sea
August 10-12 • Cambridge, MD

Manufacturing and Quality Requirements for Biotech Drug Products to Meet the New Worldwide Requirements
October 19-20 • Bethesda, MD

2016

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

2017

13th Annual FDA and the Changing Paradigm for HCT/P Regulation
February 13-15 • San Antonio, TX

22nd Annual GMP By The Sea
August 28-30 • Cambridge, MD

All materials © 1994 to 2017 by Pharma Conference and J.W. Smith

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Frequently Asked Questions