Issue



Meeting new conference programming needs


01/01/2003







We put the finishing touches on the CleanRooms East 2003 (March 17-19) conference program a couple weeks before this issue went to press, and I don't mind saying that this is the best conference we've ever programmed.

Yes, that's a pretty bold statement, oozing with a confidence that boarders on downright bombast. But before you flip to another column, put off by this editorial swagger, let me explain why I feel so strongly about this lineup.

Times have changed, and so have expectations in conference content.

This program is the direct result of fresh feedback we've received from a number of face-to-face meetings with readers/attendees up and down the East Coast. Readers from this region, known for a fairly heavy concentration in pharmaceutical and biotechnology research, development, small-scale clinical and full-blown manufacturing, have told me that they're tired of being "talked at" during conference sessions, that they would like to experience more interactivity.

Armed with this insight, we've programmed three open-panel discussions in which content will be almost entirely attendee driven. In P1: Cleanroom Systems Performance Problems attendees will have the opportunity to present their current facility problems to a panel of top cleanroom engineers who, in turn, will help develop solutions on site. Come prepared.

P8: New FDA Aseptic Guidelines Considered is designed as a group discussion on some of the main issues included in the U.S. Food and Drug Administration (FDA) concept paper released on September 27, 2002, including buildings and facilities, personnel training, qualifications, monitoring and process validation. Like P1, P8 will demand that attendees come prepared to discuss critical elements mentioned in the concept paper that can be found at http://www.fda.gov/ cder/dmpq. We might suggest that the FDA begin using ISO room classification numbers for starters.

To top things off, six of our eleven Editorial Advisory Board members are scheduled to speak, four ex-FDA investigators are on the program and a special series of sessions on Wednesday, March 19, will be sponsored by the New England Chapter of the Parenteral Drug Association (PDA).

I hope you enjoy the conference as much as we enjoyed putting it together. We'll see you in Boston in March.

Michael A. Levans
Chief Editor
[email protected]