ISPE will be hosting their 26th Annual Product Show located at Gillette Stadium on October 4th this year. This event is a great networking opportunity with many available educational seminars. Registration, parking and food are free 
for all attendees. This event begins at 8:30 A.M. with breakfast and coffee networking and ends at 9:30 P.M. with an after-show networking social. ICQ Consultants will be located at booth W27 during the exhibit hall hours, located in the west hall against the stadium windows. There is still time to register for this event and see below for some helpful links! ICQ looks forward to seeing you there, please stop by and say hello.
Directions to Gillette Stadium
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ICQ Consultants will be attending this years Biotech Week Boston. Biotech Week Boston is a festival of leading events spanning the drug development value chain. This unique festival of events includes scientific conferences, structured partnering, CEO keynotes, an awards party, a celebration of science and a little bit of rock and roll. ICQ will be attending all exhibiting hours from Tuesday September 26th through Thursday September 28th. This event will be held at the Hynes Convention Center, 900 Boylston St. Boston, MA 02115. Please stop by booth #1130 and say hello to ICQ Consultants!
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Shire will be hosting an upcoming live program on the FDA’s inspection trends and focuses featuring an ex-FDA inspector and an industry Quality representative. The event will be held Thursday, September 21 from 4:30 P.M. to 9:00 P.M. at Shire’s Fortis Lecture Hall located at 200 Shire Way, Lexington, MA 02421. The program will feature a facility tour, networking reception including refreshments and a live Q&A session at the end of presentation. The tour portion of this event is open to ISPE Members ONLY. You can register for this event on the ISPE Boston Chapter Website. Jolly Bhatia, Senior Director of Quality Assurance for 
Alnylam Pharmaceuticals and Mark Lookabaugh, Principal Consultant of PAREXEL Consulting will both be speaking. Hurry and register by 9/14/17 for discounted prices!
SCHEDULE:
4:30 – 5:15 PM Members Only Tours
5:30 – 6:30 PM Registration and Networking Reception
6:30 – 8:30 PM Presentations
LOCATION:
Shire
Fortis Lecture Hall
200 Shire Way
Lexington, MA 02421
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Recently, I have been helping ICQ with internal support tasks. One such task involves the templates we will be using in the course of client project work, to standardize our communications. Many of the templates have a field to populate the document number, and when I clicked on it to check the font properties, a box appeared around the placeholder number, and a tiny “Keyword” appeared in an even smaller grey box above it. This field is tied to the same document number field in the footer, and when one of those fields is populated, the linked field follows suit. I was intrigued. As I studied the templates, I noticed other places where information was repeated, and I thought, “If we used more of these in our documents, the form becomes more user-friendly, AND the potential for inconsistencies is eliminated.” Once I had administrative buy-in, I dug into the Word tutorials and learned how to implement the fields. If you’re thinking “How can *I* add this to my document generation skill set?”, follow me!
Step 1: If you’re interested in customizing the names of the “magic” fields, you’ll need to add the Developer tab to the ribbon at the top. File> Options> Customize Ribbon and make sure the Developer box is checked.
Step 2: Select your placeholder text. Now, go to Insert> Quick Parts> Document Property and pick one of the field titles from the list. If it doesn’t really describe the attribute, you can change the name later. (That’s why we did Step 1).
(Note: If you remove the content of the document property field, the name of the field takes its place.)
Step 3: Move to the other places in your document where you would like the information to auto-populate. Highlight the text and repeat Step 2, choosing the SAME field name.
All fields with the same name will be connected, so editing the text within one will edit them all.
Step 4: Optional renaming of the fields
Here’s where that Developer tab comes in. Click on this tab, then Properties. The pop-up menu allows you to re-label your “magic” fields.
The one minor (ironic) inconvenience is that you will have to re-name each one individually.
One final troubleshooting tip. If the Document Property menu item shows as light grey/disabled, chances are the file opened in “compatibility mode”. Simply convert it, and the option should start working.
By: Victoria Hayes, Senior Consultant
ICQ Consultants
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Please click the link below to enjoy our latest Quarterly Newsletter. Be sure to check out all the added links!
Please join us in supporting ICQ’s 
very own Victoria Hayes who will be the meeting host for the next New England PDA Dinner Meeting held on March 15th. “Microbial Contamination and Effective Facility Decontamination in the GMP Setting” will be held March 15, 2017 beginning at 5:30 pm and running to 9:00 pm at the Marriott Burlington, One Burlington Rd., Burlington, MA 01803. Dr. Ed Balkovic and Mark Czarneski will
both be presenting on the topic. We encourage everyone to attend and support Victoria. ICQ is once again a Gold Sponsor for 2017 and will be sponsoring a table at the PDA Dinner Meeting events. Please feel free to stop in and say hello!
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The Commissioning/Qualification and Validation Engineer position has responsibilities for all aspects of planning, coordination, development, execution and close out of commissioning, qualification and/or validation protocols/reports meeting quality and schedule expectations.
EXPERIENCE REQUIREMENTS
All positions require a solid understanding of the requirements for working in FDA-regulated industries within one of or more of the following areas of commissioning, qualification and/or Validation:
Process ValidationGENERAL REQUIREMENTS
EDUCATION REQUIREMENTS
BS/BA degree in a Scientific/Engineering Discipline or 2 to 15 years’ related experience working in FDA-regulated industries within one of the following areas:
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Quality standards from all institutions are periodically updated. A system that was designed to meet the quality requirements of yesterday, may not meet the requirements of tomorrow. How will you respond when an agency asks your firm if you have complied with the updates? There are many factors in determining the best course of action, but one thing is certain, the regulatory agencies will not accept doing nothing. Action doesn’t necessarily mean upgrading legacy manufacturing and computer systems throughout an entire organization to meet the new requirements. Realization of the cost of such an effort quickly jumps to the forethought. So what do you do? Well, a plan for action is a good place to start, and in most cases, is welcomed and appreciated from the agencies. So 
it’s simple, how do you get from here to there? Bring forth the “Transition Plan”.
The transition plan is the road map of how to get from there to here. Specifically speaking in terms of quality requirements, it should cover some key concepts:
The general outline here has been generated and applied for some of the ICQ clients. They have undergone regulatory scrutiny with great success. The concept has been proven in application to satisfy agencies where gaps may exist.
Written By: George Jehourian, Consultant III
ICQ Consultants
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On a previous project, I was tasked with facilitating the technology transfer of a commercial process from a customer site to the CMO manufacturing plant. The scope of the project was for the successful implementation of the upstream process into a three (3) train, 5000L working volume production suite.
Prior to undertaking the project, the site had a string of tube sealer failures while performing aseptic connections throughout the cell expansion and fermentation stages. Measures were put in place to ensure that manufacturing personnel performed additional test welds, and subsequently, multiple welds prior to disconnecting spinner flasks, media bags, etc. This turned out be a cumbersome and lengthy process, especially when dealing with time sensitive operations.
I viewed this tech transfer as an opportune time to introduce single-use, disposable technology into the facility. The idea of disposable technology was not a welcome one as it was “out-of-the-norm”. I had to start small – aseptic connectors. Flip some tabs, click a few pieces together, pull a tab, and voila, a sterile connection. No more time spent on warm up times, test welds or cuts and less risk to the process.
After reviewing the process from out-of-freeze to concentration of product, I realized that there would be a number or feeds connected to the bioreactors throughout the process, with the added impetus that all were time sensitive and deemed critical.
Introducing a single-use-technology into this process (and subsequently the entire facility) would provide ease-of-use to the manufacturing associates and also allow them to remain within the established processing parameters, avoiding unnecessary deviations, or much worse, the loss of a batch. This was enough rationale to quiet the concerns of MS&T personnel and to proceed with securing vendor samples. I found the parts I needed and ensured all information was in place (BOM, ingress studies, leachable/extractable memos, delivery timelines, etc.) for a successful kickoff to the manufacturing campaign.
As the out-of-freeze date inched closer and the vendor delivery timeline grew more and more distant, I realized that our campaign would need some fine tuning in order to meet the customers’ expectations. Luckily, we had the foresight to build into our batch records the option to weld connections, avoiding the need for planned deviations for each run. Sooner or later it became evident that the parts I ordered were not going to arrive in time. I had to communicate this to the senior leadership team and face the fact that my idea would not work.
So what did I learn?
options, the better.Written By: Gregory Fischer, Consultant I
ICQ Consultants
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Integrated Commissioning & Qualification Corporation (ICQ) is a leading provider of commissioning, qualification and validation services.
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Phone: (508) 970-8421
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