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FDA Intentional Adulteration Inspections – What to Expect and How to

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#1 Simon

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Posted 10 January 2020 - 06:46 PM

FDA Intentional Adulteration Inspections – What to Expect and How to Prepare

 

Taking place:
Friday, January 17, 2020 - 03:00 PM - 04:00 PM UK Time

This is a 10.00 AM Eastern US Start

 

Presenter:

Earl Arnold, Global Manager, QA Food Defense and FSMA, AIB International

 

Webinar Overview:

FDA plans to conduct inspections on the Intentional Adulteration requirements for larger food production facilities beginning in March 2020 and in the same manner they did with other FSMA requirements, educating as the regulate. Additionally, they say this will be reviewed as an add-on during routine inspections, reviewing food defense plans and asking questions to assist in determining compliance.

 

To help you prepare for these early inspections, we will offer a brief overview of the regulatory requirements, followed by a review of the types of vulnerability assessments, typical mitigation strategies and training for qualified individuals. We will also discuss updated information from the FDA draft guidance and FDA’s Food Defense Plan Builder 2.0. Within the discussions, we will include best practices, tips, and ways to meet FDA and company expectations.

 

Presentation Slides >>

 

Webinar Recording >>


Best Regards,

Simon Timperley
IFSQN Administrator
 
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#2 Simon

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Posted 17 January 2020 - 05:28 PM

Chat logs from today's webinar:

 

Jason Agustin : Good Morning Everyone from Toronto, Canada.
Emily Taberara : Hi everyone! From Canada
Martie Weber : Good Morning from Nampa, ID
ehsan ul haq : good evening from Pakistan
Victor Guerra : Hello! I'm from Mexico
Vivek Mohan : HI Everyone..
Titti  Taranto  : good afternoon from Titti, STS auditor, London based
Connie Mathys : Good Morning from Mosinee, WIsconsin
ROBERT SAMUDIO : Good Morning from Miami
Julia Ferrell : Good morning from Pittsburgh, PA
shiva swamy : hi
Jan Jackson : Good morning from North Carolina
David Gadberry : Good Morning from North Dakota
Barbara Harris : Goood  morning from California
Sabina De nitto : Hello1
Glen mark Nipa : good evening
Simone Kummerlöwe : Hi from Northern Germany
Christel Esbjörnsson : God evning from Sweden!
Tara Fandrich : Hello from North Dakota
Mario Araujo : Hello from Portugal.
Theresa Matts : Good day from Norwich, NY
ian reader : Ian from yorkshire
Patricia Thompson : Good Morning Everyone, Patricia Thompson from Jamaica
Kathy Balcom : good morning from Seward, Alaska
Mark Crouser : Hey all from Kansas City, Missouri.
Doreen  Hough : Morning Doreen from New York State
Andrea Rimicci : hello everybody from Northern Italy
Cathy Carlson : Good Morning from California.
Sarah Muncy : Hello from Ohio, USA
Joai Mays : Good Morning from Chambersburg, PA.
Suzy Julia : good morning everyone
Blesilda oliveros : Good morninggrom New Zealand
Jacquisha Steward : Hello- From Illinois
Evelyn Lugo : Good Morning - From V.A
Lucas  Reed : hi
Iryna Dyachenko  : Hello, from Dubai!
Murali  Murthy  : Hi Murali from NADA Dairy Saudi Arabia
Wilhelm Kamysek : Syracuse NY
tina  block  : Good morning! Tina Block, here!
Francesca  Biffi : Hello from Italy
María Rosa Cores : Maria Rosa Cores from Argentina
Farid Abdur-RAhim : Greetings
Dimitris Papapostolou : hello from Greece
Tanja Baker : Hi from Belgrade
Ernest Daigle : Good morning from Baton Rouge
Reyna Resendiz : Hello from Atlanta GA
Karen Pierre : Good Morning Everyone,  Kingston, Jamaica
Eugene Velasquez : Hello from Maryland, USA
Stacy Galster : Grandin, ND
Stephen Brown : Hi all from sunny Dover (UK)
govindasamy SUBRAMANIAM : good evening everyone, kuala lumpur
Jema Ajanwachuku : Hello from Lagos, Nigeria
James Ryan : Howdy from Texas
ilaz rexhepi : Hello from Kosovo,
Christine Diehl : HI everyone from Pennsylvania
Octavia Yankosky : Good Morning from Topeka, IN
Krystal  Florido : Hello, Good morning from Texas
María Rosa Cores : Hello everybody
Jennifer Say : Good morning from Edina Minnesota!!
Rahul  Malhotra : Hello everyone from Dubai
Vinod kumar Arya : Hi i am from india. good evening to all
Kelli Zunin : Hello from Clifton, NJ
Wendy Keith : Hello from Las Vegas, Nevada USA
Noel  Rogowsky : Good Morning from Arborg, Manitoba Canada
jade williams : Hello, from Wales UK
Robert  Rogers : hello from sunny Tampa FL
Mahmoud Al-Husseini : Good afternoon from Alexandria Egypt
Jane Omojokun : Hi from Lagos, Nigeria
Carole  Milligan : Good afternoon from London
Aimee Montoya : Hello and good morning from Colorado Springs!
Kari Pierson : Good Morning! Utah!
Mark Reyes : Hello from Lubbock, TX
Rick Reyes : Good morning from Weiser Idaho USA
Atil Gedik : hi everyone
Rachel Montgomery : Hi "y'all" from South Carolina!
TRIANTAFYLLOS CHALKIAS : Good afternoon from THESSALONIKI GREECE
Kathryn Parikh : Good Morning from Detroit Michigan USA
tina  block  : Good morning! Hi from Wisconsin!
DILEEP KUMAR GUPTA : good evening to all
Muhammd Zahir GHori : Hi. This is M. Z. Ghori
Fernando Rocha : Good morning from Mexico
christine anderson : Hello from Wisconsin
Lupita Mondragon : Hello from Mexico
Drew Pogones : Snowy here in Minnesota! Expecting 13 inches of snow today!
Brandon Rogers : Good Morning from Kansas
Snezhina Dimitrova : Hello from Southampton
Nichole Ramirez : Good Morning From Wisconsin *GO PACK GO*
Nasra Almarhoobi : Hi
Rachel Montgomery : will these slides be available?
Maria Julia Aguti : Hi From Italy
Barry Thomas : Hi From the UK
Bruce Perkin : Hey Drew, you just reinforced why I live in TX
Kathryn Parikh : HAS IT STARTED?
Craig Bahn : Hello
Victor Guerra : Yes, it has Kathryn
Bill Radnich : Bill Radnich Hello
Simon Timperley : Recording, slides and certificate will be emailed afterwards.
Kathryn Parikh : I am getting blank screen.
Simon Timperley : Kathryn use chrome or firefox browser, Internet explorer does not work.
morad abdelfatah : hi, morad from oman
Rokshanara Khatun : Hello, Rokshanara from Canada.
Daniela Anelli  : daniela anelli from italy
Jason Bashura : Greetings from Maryland, USA (not North Dakota)
Randy Keir : Good morning
James Waweru : Hello everyone. James from Kenya
Barbara Harris : B
Dirk Dhulst : Good Morning
Ndeye Mossane DIOUF : hi everyone.  Mossane from Senegal
Dawn  Allwein : TGIF from Lebanon, PA
Heidi Hyatt : For clairy, would a Pet food/treat manufacturing facility in Canada be required to have a Food Defense Plan if we ship/distribute/sell our product tot he US?
Susy Sandoval : Hi From Toronto
Kelly Gamble : Good morning from Houston, TX!
Rachel Schnell : Hello from Indiana
Margaret Maiss : Hello from Calgary, Canada
James Van Ells : Hi from Augusta, GA a bit late
Margaret Maiss : Margaret From Calgary,Canada
Houda BOUDDOU : Hello from Morocco
Narongchai Yookittichai : Can you please explain what the qualification(s) of FDQI are?
Mario Araujo : The Food Defense Plan Builder software avaliable in FDA site, which methodology fits in?
tina  block  : How could one be an FDQI?
Farid Abdur-RAhim : sound went dead
ehsan ul haq : Please explain about vulnerability assessment that is common to TACCP. and VACCP
Sherry Good : As an importer, how do we prepare our foreign suppliers to be compliant with the intentional adulteration rule? Does the foreign supplier need to have an FDQI on site?
Rick Reyes : Try restarting if you lost webinar
Lori Tansey : Hello from Tampa FL
tina  block  : my screen is still Mitigation Strategies... Is it?
Noel  Rogowsky : I took the 20hr course from FSPCA and focus was on HARPC.
Narongchai Yookittichai : Freeze slide
Nichole Ramirez : Slide Froze?
Javier Soliz : My sound came back, but frozen slide.
Simon Timperley : If frozen, click RECONNECT
Narongchai Yookittichai : PCQI and FDQI are different.
Rick Reyes : I took a course through AIB.
Christina Hunter : Hello Lori Tansey
Barbara Bouchelle : My screen is still on Mitigation Strategies also for a while
Nichole Ramirez : Clicked reconnect... Still froze
Emilie Musson : Mine too
Kelly Gamble : Good morning from Houston, TX!
Narongchai Yookittichai : Barbara Bouchelle, same as mine
Ann Baker : just changed slide for me
Ann Baker : Mitigation Strategies continuned
Ivar Pedro Joaquin Brandt Landinez : Hello From Caldwell Idaho!!
Ernest Daigle : FDA Food Defense Plan Builder 2.0 allows you to use different methodologies in conducting a vulnerability assessment
Margaret Maiss : Margaret from Calgary Canada
Sue Krentz : would the FDA Food Defense Plan Builder 2.0 be enough of a vulnerability assessment??
Jacquisha Steward : Is PCQI different from FDQI?
Suzy Julia : c
Javier Soliz : PCQI is very different from FDQI
Marina Chairez : What is FDQI?
Narongchai Yookittichai : Could you explain the corrective action when the APS is deviated, e.g. unlocked tank found. How to deal with product suspected?
Atil Gedik : as exporter from turkey. is it a must to train transporters and drvers about food defence with respect to fsma
Ivan Z : FDA Mitigation Strategies Database is not opening...
Rick Reyes : Can the training for some of these trainings be done in-house if there is a test involved to prove competency?
Marina Chairez : Thanks Victor! I will check it out.
Jason Bashura : The IA Rule does NOT require all personnel to be trained in general food defense awareness. Personnel at APS that are enusring the Mitigaiton Strategy is being applied correctly, and their supervisors, must be qualified to do that work.
Ernest Daigle : I used the FDA Food Defense Plan Builder 2.0 and really like it. I went the KAT route in my vulnerability assessment.
Lauri Glasgow : Rick, AIB has an online course.
Lori Tansey : Hello Christina. 
Rick Reyes : My problem is that most trainings are not conducted in Spanish which is the predominant language at my facilities.
Phyllis Ricardez : anyone have an easier formula for determining public impact?
Narongchai Yookittichai : Alchemy Academy can provide the training in Spanish. I think.
Rachel Montgomery : Please confirm you said that FDA will assess FDP with regular audits when they begin assessing IA compliance in  March 2020?
Jason Bashura : It's been shared publicly that the FDA has indicated that the QUICK CHECKS will be based on section 121.126 of the IA Rule:  the Food Defense Plan requirements section.
Narongchai Yookittichai : OMG - Quick Check???
Lynnice Sanchez : Are FDA audits for food defense being scheduled by the size of each company similarly to preventive controls audits
shiva swamy : What is factor affecting deciding reasonable time frame?
Stephen Brown : Thanks Earl
Titti  Taranto  : thank you
Barry Thomas : thank you, will this webinaire be on line?
shiva swamy : What is the minimum cap for terming a liquid product under bulk shipping?
Diana  Samson : thank you
James Ryan : Earl, good prsentation.  Very helpful and informative.
Mark Crouser : If you have any additional questions for Earl, please visit https://www.aibinter...com/webinarhelp.
Diana  Samson : any recommendation for evaluating food defense plan for food packaging
Rokshanara Khatun : Do we require food defense program if we are small facility, < 10M annual sale?
Jan Jackson : very informative!  Thank you!
James Ryan : As an exempt pet food manufacturer do we still need to ask FDA for the Exemption?
Houda BOUDDOU : what is the difference between PCQI and FDQI?
Kelly Gamble : When we consider our sales for how we might be categorized in size (very small, small, large, etc), does our raw goods inventory count? Or just sales?
Jason Bashura : Does AIB have the ability to share "common" mitigation strategies they're seeing in the field that firms are leveraging to reduce vulnerabilities?  Are a majority of them Personnel based vs technology based?  THanks Earl for a GREAT presentation!!
Alexandra Oropesa Navarro : Is beer industry required by FDA to have a Food Defense Plan?
Miki Taira : Will FDA go inspect oversea mfg. for Food Defense Plan?
Ivar Pedro Joaquin Brandt Landinez : Earl, great work awesome presentation, very useful information!!
Mario Payán : What is the best way to verify the intentional adulteration, if in a company there is no cameras?
Javier Soliz : Military Food Inspector explains why Earl is in silhouette
Henry Ezekiel : is potential public health impact be required to reflect on the food defense plan?
ROBERT SAMUDIO : We are Food Distributor Do we have to have a Food Defense Program?
ehsan ul haq : Please explain about vulnerability assessment that is common to TACCP. and VACCP?
Carrie Dickerson : Will the March 2020 inspections include foreign FDA registered facilities as well?
Drew Pogones : How will this work with CBD/Hemp products? I assume the same as typical food and beverage industry?
Ivan Z : https://www.cfsanapp...egies/index.cfm
Reyna Resendiz : so should a company that has building in 2 different state have 1 food defense plan or 1 for each company in each state?
Victor Guerra : What do you recommend to train staff in Food Defense?
sudarat  Chunpranlert : As an importer, are we required to review and document our supplier's food defense plan?
Perla  Vargas : Are exposed product, suck as ready to eat commodities in bulk (Fruits and Vegetables) except?
Titti  Taranto  : thank you alot
ehsan ul haq : very good presentation thank you very much!
Victor Guerra : Thank you!
Sherry Good : Thank you!!!
Kelly Gamble : Thank you!
christine anderson : thank you!!
KEE KEE GOH : thank you
Lorraine  Baxter-McPhie : Marvellous thnak you Earl
Mark Reyes : Thank you!
Javier Soliz : Handclap!!
Stephen Brown : wohoo thank you
James Ryan : clap clap clap
Reyna Resendiz : thanks for all the information
Iryna Dyachenko  : Thank you very much! Amazing training
Suzy Julia : Thank you for the great presentation Earl
Noel  Rogowsky : thank you Earl!
Mario Araujo : TOP
Matthew White : thank you
Kari Pierson : Thank you Earl!
SUSIE TRAN : thank you!
Doreen  Hough : thank you
Barry Thomas : Thankyou
Sivaram Kumar Selvarajan : Very dynamic and clear presentation. Thank you very much.
Carrie Dickerson : That was great!!!
Krystal  Florido : Thank you!!
Francesca  Biffi : thank you!
Dania Leyshon : Thank you
Henry Ezekiel : Thank you!
Murali  Murthy  : very detailed presentation thanks
Christel Esbjörnsson : Thank you!
cary baird : Thank you Earl.  Excellent presentation!
Bill Brochin : Excellent, great presentation
Emily Taberara : Awesome presentation! Thank you both and have a great weekend!
Narongchai Yookittichai : Thanks
Rick Reyes : Thank you so much Earl.
Leonel Henao Orozco : Great Webinar!!! Thank you very much!
Rachel Montgomery : Well done presentation, Earl!   (very informative and Not a single "uh"   Thank you!
Iryna Dyachenko  : The best Trainers are from AIB!
Fernando Rocha : Thanks
Sivaram Kumar Selvarajan : Thank you Earl and AIB.


Best Regards,

Simon Timperley
IFSQN Administrator
 
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Need food safety advice?
Relax, you've come to the right place…

The IFSQN is a helpful network of volunteers providing answers and support. Check out the forums and get free advice from the experts on food safety management systems and a wide range of food safety topics.

 
We could make a huge list of rules, terms and conditions, but you probably wouldn’t read them.

All that we ask is that you observe the following:


1. No spam, profanity, pornography, trolling or personal attacks

2. Topics and posts should be “on topic” and related to site content
3. No (unpaid) advertising
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5. Enjoy your stay!


#3 AB Perkin

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Posted 17 January 2020 - 05:46 PM

Hi Simon,

I recall that the presenter today said that if you were a very small business, that to get the exemption, you needed to apply to the FDA and get them to grant you the exemption.

That got me going and went onto the FDA web site to see what format I should present the application in.

This is what I found:

 

§121.5   Exemptions.

(a) This part does not apply to a very small business, except that a very small business must, upon request, provide for official review documentation sufficient to show that the facility meets this exemption. Such documentation must be retained for 2 years.

 

Seems like we do not need to apply - just be ready to present the information when requested.

 

Can we check in with the presenter to make sure we are all on the same page?

I want to make sure I am not missing something.

Thanks

Best Regards

Bruce


Edited by Charles.C, 18 January 2020 - 03:00 AM.
post moved from file lib. dwl thread


#4 sangle

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Posted 17 January 2020 - 07:37 PM

Dear AB,

 

I wondered the same thing and contacted the FDA regarding the matter.  They sent me a letter stating; "Facilities that are not required to register under section 415 of the FFDCA are not subject tot he IA rule.  There is no attestation form for facilities that are not subject to the IA rule or that may be exempt."

 

Shanna


Edited by Charles.C, 18 January 2020 - 03:00 AM.
post moved from file lib. dwl thread






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