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February PDA Letter
Free Articles to All PDA Members and Non-Members.
New Participation Opportunity: Nominate a BoD Candidate
PDA’s Board of Directors has adopted a new open nomination process for Board of Director/Executive Committee elections, starting with the 2012 BoD election later this year.
PDA’s Board of Directors has adopted a new open nomination process for Board of Director/Executive Committee elections, starting with the 2012 BoD election later this year.
Lack of Compendia Harmony for Visible Particles Causing Confusion
The major compendia have harmonized the testing methodology and acceptance criteria for subvisible particles; however, the absence of a harmonized guidance for visible particles has led to confusion in the global industry.
The major compendia have harmonized the testing methodology and acceptance criteria for subvisible particles; however, the absence of a harmonized guidance for visible particles has led to confusion in the global industry.
Audit Program Part of FDA Pathway for Global Product Safety
The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) are testing a Pilot Multi-Purpose Audit Program in 2012 and 2013 that will allow medical device companies under their jurisdiction to voluntarily submit certain audits and receive Agency inspection relief for one year.
The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) are testing a Pilot Multi-Purpose Audit Program in 2012 and 2013 that will allow medical device companies under their jurisdiction to voluntarily submit certain audits and receive Agency inspection relief for one year.
Progress of the Quality Topics at the ICH Meeting in Seville
It is anticipated that further discussions among the constituencies, with focus on control strategy, should lead to the final version of ICH Q 11(Step 4) before the end of the 2nd quarter in 2012.
It is anticipated that further discussions among the constituencies, with focus on control strategy, should lead to the final version of ICH Q 11(Step 4) before the end of the 2nd quarter in 2012.
Read the full February Issue (Member's Only)
Read about the lack of compendia harmony for visible particles and FDA’s multi-purpose audit program. Check out the Faces & Places. Learn how to nominate someone to PDA’s Board of Directors.
Read about the lack of compendia harmony for visible particles and FDA’s multi-purpose audit program. Check out the Faces & Places. Learn how to nominate someone to PDA’s Board of Directors.