Parenteral Drug Association

March 15-19, 2010 Orlando Florida
Examine manufacturing best practices and strategies to maximize your company’s efficiency and productivity!

2010 PDA/FDA Pharmaceutical Supply Chain Workshop

Enough Talk: Let’s Find and Implement Solutions
April 26-28, 2010 | Hyatt Regency | Bethesda, Maryland

2010 PDA Europe Workshop on Stoppers & Elastomers
March 24-25, 2010 | Cologne, Germany

Upcoming PDA Web Seminars
Environmental Monitoring in Isolators, Single-Use Disposable Process Technologies and Fundamentals of Lyophilization in Syringes

Now Available
The March PDA Letter!

Preparation of Virus Spikes Used for Virus Clearance Studies is now available!
PDA members can access TR No. 47 for free until March 31, 2010!

June 7-12, 2010 Pharmaceutical Cold Chain Management on Wheels
Join the WHO (World Heath Organization) and PDA for the Pharmaceutical Cold Chain Management on Wheels, June 7-12, 2010 in Turkey. This course will provide key players of the pharmaceutical cold chain with insights into complete cold chain operation and oversight from product manufacture (or arrival in a country) to its administration to the patient.
ICH Quality Implementation Working Group (Q-IWG) Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10
Europe: 2-4 June 2010 Tallinn, Estonia
USA: 6-8 October 2010 Washington, DC
Japan: 25-27, October 2010 Tokyo

Practical training on integrated implementation of Q8, Q9 and Q10 in pharmaceutical development, manufacturing, regulatory assessment, scale up to commercial operation, and GMP-inspection. This is an opportunity for open dialogue among industry and regulators on: Comprehensive training on regulatory aspects, technical development and manufacturing, case study combining Q8, Q9 and Q10 and regulatory topics related to submission expectations and GMP-inspections.
The Call for Papers Deadline for the 2010 PDA Biennial Training Conference has been Extended to March 15!
Please submit your abstract by March 15 for consideration. The theme of this conference is Training and Performance in a Changing Environment.
Pre-ordering is Now Available for PDA's Technical Report Compilation on Filtration
This is your opportunity to own a comprehensive, single-source compilation of PDA filtration Technical Reports available. Used as a powerful reference tool for individuals working with filtration processes for water and virus removal, this compilation will be an invaluable guide for you to navigate the scientific and regulatory aspects of filtration.
Call for Papers: PDA’s 5th Annual Global Conference on Pharmaceutical Microbiology
The Program Planning Committee for this conference invites you to submit a scientific abstract by March 22 for presentation. The theme of this year’s conference is Advances in Microbial Control and Product Quality.
April 26-28, 2010 PDA/FDA Pharmaceutical Supply Chain Workshop – Agenda Available Online
There has been a lot of talk about supply chain difficulties facing our industry, it’s now time to find and implement solutions! The agenda is now online to give details about this one-of-a-kind conference, co-sponsored by the FDA in Bethesda, Maryland.
NEW PDA/DHI Release - Validation by Design: The Statistical Handbook for Pharmaceutical Process Validation
PDA is please to announce the publication of Validation by Design®: The Statistical Handbook for Pharmaceutical Process Validation addresses the statistical issues expressed and implied in the US FDA’s Guidance for Industry Process Validation: General Principles and Practices, Draft, November 2008.
Call for Papers: PDA's 2010 Universe of Pre-filled Syringes and Injection Devices
The 2010 Universe of Pre-filled Syringes and Injection Devices Program Planning Committee invites you to submit a scientific abstract for presentation at the conference. The theme of this year’s conference is The Advanced Needs of Pre-filled Syringes and Autoinjectors.

Validation by Design®: The Statistical Handbook for Pharmaceutical Process Validation
Lynn Torbeck

Cleaning and Cleaning Validation, Volume 1
Editor: Paul L. Pluta, PhD

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