Pharmaceutical Stability Discussion Group Fall Meeting

The PSDG Fall Meeting for 2014 will be held October 5 from 3 to 9 PM at the Mayflower Park Hotel in Seattle, WA.

The purpose of the meeting is to share information on a broad range of stability topics over the entire course of the meeting, so the quality and success of the meeting rely on a commitment to avoid filling the seats with those who are “there to learn” as opposed to those who are “there to share.”

The presentation portion of the PSDG meeting is a complimentary 2-hour mini-course provided on Sunday from 3:00 – 5:00pm by PSDG vendors or participants regarding focus-topics associated with the stability function. … more

How not to GMP….

In a recent warning letter dated July 8, 2014 the FDA identified a number of practices that do not fit with the expectation of Good Manufacturing Practices.  Examples from the warning letter include:

  1. Incomplete Batch Records the use of “unofficial” visual inspection records with data that was different from the “official” batch records reviewed by the quality unit.

Art Bender Scholarship

Art Bender Scholarship – Sponsored by the Indianapolis Section (0903) of American Society for Quality. The deadline for application for the Art Bender Scholarship is November 15th. You do not need to be an ASQ member to apply, however you do need to be an Indiana student, attending an Indiana…more for additional details on eligibility and application process.more

Supply Chain

As reported by GMPTrainingsystems, FDA Focuses on Supply Chain, which included an excerpt from Dr. Sharfstein, MD, FDA Principal Deputy Commissioner, where he addressed the safety of the supply chain on Oct 22, 2009.  Dr. Sharfstein stated:

“What keeps Dr.… more

Repackaging Compounder

In a recently posted USFDA warning letter, a compounder repackaging Avastin for ophthalmic use was doing so in a clean room with a wall mounted air conditioning unit and no adequate system for cleaning and disinfecting the room or equipment to produce aseptic conditions. … more

Trifarma – Cited for Data Manipulation/ Integrity

In a recently posted US FDA warning letter, Trifarma, an Italian API manufacturer was cited for significant deviations from current good manufacturing practice.  Specific violations as identified in the warning letter included:

Failure to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertaining to data retention and management.… more

Free Regulatory Training

In a small medical device company and unsure how to navigate the FDA regulatory requirements?  The USFDA has initiated a National Medical Device Curriculum to help academic institutions and science and technology innovators understand FDA’s medical device regulatory processes.

CDRH Learn is your starting point! … more

IMDMC Presents FDA Regulatory 101 Training – Day 2

The Indiana Medical Device Manufacturers Council is presenting Day 2 of the FDA Regulatory 101 training course, August 19, 2014 from 8 AM to 5:15 PM at the Montage Banquet Center.

FDA Acting District Director Art Czabaniuk has confirmed that he will be joining the faculty for Day Two.  … more

Data Integrity/Manipulation

A content search of posted USFDA warning letters for “data integrity” returns 34 warning letters.  A content search for “data manipulation” returns 11 additional warning letters.  Removing duplicates, the same warning letter issued to firms for both data integrity and data manipulation, results in 36 issued warning letters for these topics.… more

Data Integrity/ Data Manipulation Issues

At the ISPE/FDA Conference Baltimore 2014; Data Integrity/Manipulation was a key topic.  While several examples were provided from recent warning letters of Indian companies both FDA and Industry speakers cautioned that this issue is not limited to pharmaceutical companies established in emerging markets such as India and China. … more