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FSMA and Foreign Supplier Verification program (FSVP)

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#1 Simon

Simon

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Posted 05 November 2017 - 05:34 PM

FSMA and Foreign Supplier Verification program (FSVP)
 

Taking place:

Friday, November 03, 2017 - 03:00 PM - 04:00 PM UK Time

This is a 10.00 AM Eastern US Start
 
Presenter:

Ruby Ochoa, President/Owner, Trace Analytics, LLC 

 

Webinar Overview:

Are you a Broker or Agent? What about an Importer of Record from a foreign supplier? If you are, then understanding the rules around FDA's FSMA and Foreign Supplier Verification Program (FSVP) are critical to your business. Join DNV GL to understand the deeper impact of how this program affects your business and some of the methods to prepare your systems to meet FDA requirements.

 

Presentation Slides >>

 

Webinar Recording >>


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Simon Timperley
IFSQN Administrator
 
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#2 Simon

Simon

    Grade - FIFSQN

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Excellent

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Posted 05 November 2017 - 05:35 PM

Chat logs:

 

Pam Jordan : Is there a call in option?
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DARLENE : No call in option.  Will not be a choppy soon
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Katherine : Hello to everyone from Bolivia! I am Katherine
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defri : hay im from indonesia  
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Jane : The audio is bad. It's echoing so much. 
ANDRIANA : Hello from Athens, Greece
Terina : audio issues
Jema : Hi from Lagos,Nigeria
Amanda : I can no longer hear the speaker
Terina : alot of echoing now no sound
Elizabeth : not getting audio
Jennifer : sound just switched to a non-speaker
Patricia de García : No audio
Doreen : audio is out
Roderick : Sound dropped out
Adrienne : Hello from NJ
simao : Hi from Portugal!
sara : Sound went out
Christine : what happened to the audio?
Beatrice : I can't see anything?
Kim : Lost Sound?
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Radojka Barycki : Sounds is not playing anymore?
vahini : No audio
Kunyi Jiang : there is no sound 
Rachel Robinson : I have no video
Lori Erickson : no sound here either
Milda : sound gone in Denmark too
Ron : No sound
anamarija : no audio also
Matt : I have video but no sound
kousik : no audio ?
Susy Sandoval : HI my audio stopped
Vanessa : audio dropped
Spring : No sound here
Nila : Hello,  There is no audio, even after reconnecting.
Michelle : Good morning from Minnesota...the sound is gone.
Larry : Lost sound
Sunil Joseph : Lost voice
maria : No audio - southern california
jennifer : I can hear you
Argentina : No audio, no video
Sophie Soumah : No sound
Mohammed : Sound and image are not fixed
Martin : no audio, no video
Ana : Hi! problems with audio
The : I cannot see and hear anything
Bill Bremer : We are trying to reconnect.
Kimberly : ok I am now hearing
Lori Erickson : no 2nd
Jim : Hello from Nashville, TN
DARLENE : SEVERAL
Seema : problem in coonection 
Jennifer : yes, first webinar with you
rihab : good morning . rihab  from texas
David : 1st today !
bonny : 2nd one
DIana : 1st one
sara : I can hear you now
Patricia de García : Several
Vanessa : several
Duane Lau : 2nd
Larry : Several
Erin : First webinar attended on this subject
aNDREA : 2nd 
Adrienne : 1st one
Elizabeth : I've done several
jlucier@scoular.com : a few
Michelle : I've been coming since the beginning - you are the BEST!
Amanda : First
Cathy : several
sara : several
Kim : several
Kimberly : click on reconnect if you have no audio or video
Heida : several
Maxine : SEVERAL
Rachelle Catellier : 1st one
Lori Erickson : the first one was good so i came back for another lol
jose : several
Spring : several
Aparna : several
Jenny : several
Grayson Craig : 1st
Jim : first
filipa : 1 st
Cary Baird : Several
June Ly : I attend several training
Michael : Most
mukesh : 1st
Bria : the internal audit meeting if we cannot attend will we be able to contact the presenter with questions after if we cant attend live
Esther : Several
Milda : greatest webinars ever! I had arround 7
Jema : Several
Stephanie : most
Lewis : 10th
Trisha Rampe : Several
Harwin : 3th
nadia : I wasn't able to get my certificate from the last time, but this is such a ggo idea
Doris : Several
Jennifer : It's ok, these things happen
Reg : hi
Jiten : Are we running late? 
Juanita Rubio : 1st one thank you 
Casilda : several. Most last year only one or two this year.
Camila : Good morning from Purchase, NY!!
Brenda : Several Webinars, I appreciate these webinars, I always learn something
Kimberly : several
nadia : i will go onto the auditors course if I can get time off work
Reg : hi from Maypro
Casilda : looking forward to FSL 2017
Tami Schueler : Will there be a replay of this video? I am not allowed to view this at this time.
Ken : Hi Reg
mukesh : hurrry
Niesha : Youtube link please
Raina : This is my first time for this webinar. Hello from Dallas, TX! 
Maxine : +
Raul : first
Cary Baird : The presentation is going on -- with Simon talking over it unfortunately!
Seema : how to down load this slides 
Cheryl : cheryl- St Louis, MO
Seema : i want this ppt 
Natalia : i cannot hear or see anything...
mary claire lozarita : hello from the Philippines
Jennifer : Are "Food Safety Plan", "Quality Manual" and "Quality Food Safety Manual" synonymous with each other? Is one label globally preferred?
Amit Kheradia : When developing HARPC plan, do we have to factor in FSVP into this plan, (or) is HARPC only about Final Rule for Preventive Controls for Human Food?
mary claire lozarita : Hi Sittie, are you In?
Judy : Hello from New Jersey
Jennifer : Can very small companies get an exemption from having a PCQI on staff?
asatamaria67 : Hi from San Diego
Kaushalya : Hello from Toronto
Dario : audio works fine here
Sittie Ameerah Khan : Good evening from Philippines.
mary claire lozarita : no sound
Mohammed : sound is clear
Seema : i wants to take a training on BRC regulation in India 
filipa : Hello from Portugal
Lawrence : Hello from UK
Mohammed : Hello from sudan
DARLENE : FSVP is separate from HARPC
Jane : Can foreign suppliers get the PCQI training online and are there certified trainers for it? If yes where do we get the list?
mary claire lozarita : Hi simon, if we have attended the 1st paid webinar then we were not able to download the materials, can we still have it after sometime together with our certifications/ thank you
Elizabeth : There are online PCQI training options available. Just search online for "online PCQI training"
HERNANDO : Hello from Guadalajara
mary claire lozarita : o you have a scheduled training webinar about the Qualified Individual as required by the FSMA
mukesh : is haccp plan defferrs from food safety plan
Sarah : qualified auditors for internal audits?
Seema : What do you mean by qualified auditor 
glenn : will a recording of this webinar be available
mary claire lozarita : PCQI do we have scheduled trainig for this now?
Teresa Kloch : will the slides be available to print 
sara : We haven't talked about FSVP yet
Raul : Audio is bad
jennifer : We purchase from a manufacturer that has several plants in the US and a few plants in Europe. Do we need to have additional requirements for the plants outside of the US?
Jane : Can foreign suppliers get the PCQI training online and are there certified trainers for it? If yes where do we get the list?
teresa : Hello from Portugal, the slides will be available in the end?
Maxine : Are USA importers required to have a PCQI in their facilities?
Summer : May I get a copy of the slides due to distractions?
DARLENE : Maxine, YES
binu : There is an issue with the sound
Bria : Jane there are some companies that have online training Ive only ran across 2 so far. I used Alchemcy which was online
Bria : Alchemy
Stephen : Stephen from Trinidad and Tobago 
Jiten : I am not sure if it is my connection or I am having problem with video every few mins now
Staci McCarvey : I would love to have copy of this for management. Thank you! 
Lin Mazurek : HI JANE, YOU CAN FIND INFORMATION ABOUT PCQI ON THE WEBSITE: www.dnvglcert.com
Simon Timperley : slides and recording will be issues by email to allll registrants later
Megan : If you are complaint with 21 CFR 211, are you subject to any parts of FSMA (21 CFR 117)?
Jane : Thanks Bria. Was the training acceptable to US?
Sittie Ameerah Khan : thank you Simon.
Sharon Warner-Hanna : I thought this webinar was about FSVP?
Susan Heller Evenson : Does anyone know that an importer of green, unroasted coffee (use 3p warehosu) exempt from FSMA rule since not processing?
Jiten : I am missing most of the training now,
Bria : Jane I used Alchemy and it is. 
Seema : Thanks Simon
Mahmoud : Can you send us a copy of this presentation?
Adrienne : This webinar is buffering constantly, is that happening to everyone else?
Matt : Just lost audio
Terina : no sound again
Patricia de García : Again, no audio
mukesh : what wil happen then we have take more than 24  hour
Roderick : Lost Sound again
Jane : Thanks Lin. Do the online  trainers  not need some kind of certification from the US to be sure it's acceptable or are they certified trainers?
sara : lost audio
Terina : we lost all sound
Milda : gone again
Glenn : Lost audio
Adriana Malek : lost audio
Susy Sandoval : Oh no
David : no screen
Roderick : No sound!
sara : Sound went out
Bria : cant hear you simon
David : no sound
Patricia de García : Not able to listen to Simon
Kimberly : lost sound again
Seema : lost audio 
Matt : Simon, can't hear you
Sarah : if you use Alchemy for PCQI training it is recognized by the FDA as beigng compliant
mukesh : no sound
Rachelle Catellier : no sound again
Lei : no sound
Niesha : no sound
Eb : sound went out also
Kayleen : can't hear you!
Francis : simon we lost sound of you
Martin : lost Audio
Ramon : no sound again
Nila : No Audio.  cannot hear you Simon
Elizabeth : Can't hear Simon either
Kim : no sound again
mukesh : still no sound
David : no sound Simon !
Sandra : no sound
Larry : No sound
anamarija : lost sound
bev : Lost Simon now too...
Abdul Ghafar : Lost the sound
AbdulRahman : I can not hear you Simon
Mary Williams : no sound
Kimberly : i reconnected but still no sound
Delia : Cant hear u Simon
Doris : No wound with Simon either
Mohammed : no sound
bob : ok
Lori Erickson : haha
Megan : sound has returned
Ramon : there you go
Abdul Ghafar : yes....got it.
Kimberly : ok its back now
mukesh : ok 
Patricia de García : OK now!
Beatrice : I don't see the slides, but a person?
Francis : Hooray
Kimberly : one of those days
David : we can hear you now Simon
Lori Erickson : i hear you now
jennifer : Audio is back on
jennifer : Thank you!
Isabel : no sound
Lisa : Can not hear Simon
sara : ok now
Eb : sound ok now
jennifer : We purchase from a manufacturer that has several plants in the US and a few plants in Europe. Do we need to have additional requirements for the plants outside of the US?
Iryna Dyachenko : no worries, it was great!
anamarija : still canot hear
Juanita Rubio : got audio back
sara : I reconnected and now I can hear Simon
Bill Bremer : We should be back now.
bonny : yes
Katherine : Yes
Maxine : Thanks Darlene
Rachelle Catellier : yes
Ashley : Yes
Sharon Warner-Hanna : YES
Isabel : ok, now
Lori Erickson : yes it does
mukesh : what will we do when we take more then 24 hours in traceability
Zin : yes
Larry : yes
bev : yes
Roderick : Yes
Glenn : Yes
Melissa : Yes
Jennifer : yes
Kim : Yes
Maxine : yes
Dee : yes
Chris : Yes it does
jose : YES
Mohammed : yes
Beatrice : I hear you
Afton : yessss
Christy : No
Jane : Thanks Bria. I appreciate it
Teresa Kloch : yes
Iryna Dyachenko : yes
Sunil Joseph : Audio gone again
Jim : YES
Delia : It applies
Bria : Jane, you can search the FSPCA and they maintain a list of recognized trainers
Milda : no yet
Kim : applies to my clients 
June Ly : No
gabriel503984 : Audio is back
Angel : yes
f : yes
Kimberly : yes
Lin Mazurek : WE ARE ATTEMPTING TO REGAIN THE AUDIO WITH HQ
Harwin : yes
Grayson Craig : Indeed
Kenly Edwards : do the FSVP hinges on the size of your operation
sara : It applies
Amit Kheradia : yes
miki : lost connection 
Christine : YES
Spring : yes
Aracely Robles : are you going to share some experiences of FSVP programs implemented
Kathy : no we are not a direct importer
Elizabeth : This webinar isn't covering FSVP. It's covering PCHF
mukesh : if we commplete in more then 24 hours
Susan Heller Evenson : don't believe so since importing green/unroasted coffee and don't own warehosue 
DARLENE : KENLY, YES
Beatrice : yes
sara : yes
Seema : yes
mukesh : yes
Monica : yes
Aracely Robles : audio back
Bria : Jane, here is the link to the Food Safety Preventive Controls Alliance, https://www.ifsh.iit.edu/fspca. They have a list of trainers that are recognized by FDA
Lisa : Good to go
Nazeer : yes
Jiten : video and audio back but still ongoing issue
Megan : I am not sure if there was a response to our question as I had to reconnect. If you are compliant with 21 CFR 211, are you subject to any parts of FSMA (21 CFR 117)?
sara : Validated for all condition?  What does that mean
jennifer : We purchase from a manufacturer that has several plants in the US and a few plants in Europe. Do we need to have additional requirements for the plants outside of the US?
Sunil Joseph : Still no sound
aNDREA : how do you validate your recall/traceability program?
Nestor : Mock recall
Mohammed : suppliers must be verified and qualified
sara : mock reacll would be the verification if I'm not mistaken
Sunil Joseph : Yes
kari valickas : Will this presentation be available after the webinar?
aNDREA : mock recall is verification so how do I validate that?
Mohammed : i think it depends on ethical considerations
Afton : HI DANIELAAAAA!
Muhammad Zahir : Mock recall 
Daniela : HI AFTONNNNN!!!
Monika : Hi 
Mohammed : service providers? is this pre quisite programms in HACCP
Melissa : I was under the impression that this webinar would focus on FSVP
DARLENE : Your validation would be "did it work?"
DARLENE : Andrea...mock recall is verification...did you recover all and within required time?  If so, it's validated
Sarah : we validate the recall program by evaluating the last 2 years to see if we have 100% trace
Jane : I read somewhere that  FSMA does not  require farmers to have a Food Safety Plan but recommends they  do to help them to be organized. Is this correct?
aNDREA : Thank you Darlene
DARLENE : Jane, true
Sarah : Darlene, what is your background? 
Jane : Thanks Darlene
DARLENE : PCQI, FOOD SAFETY TRAINING, HACCP AND HARPC TRAINING, FSVP TRAINING; BRC
Sarah : thank you. I have HACCP, PCQI and am in charge of our BRC audit
Adrienne : While I was in my training class for PCQI in NJ, my instructor told our class that HARPC was not going to be implemented.  Is that true?
Sarah : HARPC is now the PC rule
Grayson Craig : Farmers have different requirements to be in compliance with FSMA
DARLENE : Well done Sarah...lots going on !
Elizabeth : FSMA regulations only apply to entities that are required to register with FDA. Farms are exempt from registration requirements, so they aren't subject to FSMA, including the PCHF.
Seema : Please describe HARPC
Darryl : Jane, true
Sarah : Darlene are you withih the US?
DARLENE : HARPC  is HACCP while adding PCs
DARLENE : Sarah, Yes
Seema : Thanks 
Bria : Seema: HARPC - hazard analysis risk based preventive controls
Kathy : I would like more detail and how to implement a good foreign supplier verification program
Elizabeth : HARPC  = Hazard Analysis and Risk-Based Preventive Controls Rule. It is the formal name of the regulation. Most people now refer to it as PCHF - Preventive Controls for Human Food rule. There is also a preventive controls regulation for animal food.
Lawrence : What is the difference between HACCP and HARPC
mukesh : where can we get FSMA section 117
Seema : Thanks Bria
Sarah : Darlene, are you training your staff on the new cGMPs? 
Sarah : google 21 CFR 117
Darrell : We need help with FSVP compliance
Amit Kheradia : Darlene - thanks for clarification between PCHF and FSVP. But, Why is HARPC covered when the presentation is on FSVP? Is FSVP a subset of HARPC or is it the other way round?
mukesh : ok thanks
Elizabeth : 21 CFR 117 is here: https://www.accessda...cfm?CFRPart=117
Darryl : Is HACCP and HARPC synonymous?
Sharon Warner-Hanna : This webinar is an overview of FSMA.. NOT FSVP
Elizabeth : This webinar is NOT covering FSVP. It is covering PCHF.
Bria : Darryl HACCP & HARPC are not synonomous
Megan : most current version of 21 CFR 117: https://www.ecfr.gov....2.117&rgn=div5
Mohammed : Hazard Analysis and Risk-Based Preventive Controls: Improving Food Safety in Human Food Manufacturing for Food Businesses is a comprehensive, first of its kind resource for the retail food industry on the Hazard Analysis and Risk-based Preventive Controls
miki : Lost audio 
DARLENE : Sarah....ongoing
Bria : GFSI Certification is not the same as FSMA Compliance. 
Rachelle Catellier : will you be convering the requirements for FSVP?
Darryl : Oh, thanks bria
sara : the webinars are always great, today's webinar got the wrong title
Raul : \Hi Darlene, I have a customer who keeps asking if my company is FSMA certified?  What does she mean?  I have told her that I have my preventive controls in place and she is not accepting this?  Can you help me? 
Nila : HARPC - does this mean preventive controls for intentional or deliberate contamination? Is there a template or a procedure on how to do this?
Elizabeth : FDA has developed a Food Safety Plan builder. Here is a link"
DARLENE : Raul...you would need a 3rd party to actually audit your compliance with FSMA
Nila : We are a supplier of primary packaging material, do we need to have an approved PCQI?
Elizabeth : There is no such thing as FSMA certified.
Megan : you receive templates during PCQI training courses for HARPC
Maxine : What are the requirements for training for a Sanitation Manager.?
Farida Hosein : can some share the templates
Mohammed : Can we receive templates or material for this  session 
Amit Kheradia : thanks Elizabeth for Food Safety Plan Builder Link
Susy Sandoval : can you give an example of validation for FSV
Raul : Thank you Darlene = Who can do this third party audit?  I am currently SQF certified?  I am the Internal Auditor and PCQI also.  Can I do it myself? 
Sarah : SQF is your 3rd party audit
DARLENE : Raul...key is 3rd party accredited audit
DARLENE : SGS is very good
Farida Hosein : Elizabeth can the share the Food Safety Plan builder
DARLENE : GFSI does NOT mean you are in compliance with FSMA
Vanessa : will the powerpoint be sent out after the webinar
Elizabeth : Be aware that current 3rd party audits under SQF, BRC, etc. are not technically FSMA audits.
kousik : Does FSMA and PC cover seafood HACCP ?
Grayson Craig : Raul You cannot do a 3rd party autit yourself. You would need another company to provide that. Internal audits/mock audits can be done by yourself.
bernard : Bill, would you please expound on documented FSV validation declaration? Components and signatory?
Susy Sandoval : you have an eco 
mukesh : what if we complete traceability in more then 24 hours
jennifer : We purchase from a manufacturer that has several plants in the US and a few plants in Europe. Do we need to have additional requirements for the plants outside of the US?
Mohammed : thanks
DARLENE : Mukesh...would not be a validated program
Ken : Mic feedback makes it hard to hear
Sarah : i know that GFSI doesnt equal FSMA complianr
Juanita Rubio : Darryl- HARPC is adding preventive controls to the whole process   
Terina : when our FSP produces from 43 differnt farms do we as the importer need documentation from all farms or is that the responsibility of the broekerto supply?
Kimberly : and there a number of PCQI lead instructors in various countries
Adriana : FSVP documentation is present to FDA by us (our industry) or an external agent??
mukesh : ok so traceability program become a non compliance 
Amit Kheradia : kousik - FSMA/PC and Seafood HACCP are different, they don't cover each other
Susan Heller Evenson : I work for an importer of unroasted/green coffee and don't own a warehouse, so think I'm exempt from FSVP and FSMA. Do we still need to send a document to our roasters saying they are responsible for preventative controls of identified hazards>?
DARLENE : Adriana...if your company must comply then you are responsible for having all information ready for FDA
Sarah : Susan are you FDA registered? 
Mohammed : Sarah...GFSI certification equals FSMA compliance 
Monica : I personally am having some trouble carrying the message across to our foreign suppliers.   can you offer some guidance?
mukesh : ok thanks i understood it will we in 4 hours
Sarah : Mohammed, it doesnt. 
DARLENE : No Mohammed...not really
Susan Heller Evenson : Sarah - yes, we are registered with FDA
Mohammed : why?
kousik : @Amit -- we manufacture veggie salad,  seafood salad and meat salad.. do we requeire to have a HARCP safety plan + Seafood HACCP safety plan separetly ? 
Jennifer : our foreign suppliers do not want to send their full safety plan to their US customers as they feel it is a road map to their process. What aside from the customer personally auditing the factory is the alternative?
Sarah : I believe if you are FDA registered, you must be FSMA compliant. 
Katherine : If our company is certified with ISO 22000, does it have to change to comply with FSMA or can we just review our management system and complete it, if necessary? thanks
DARLENE : Mohammed...missing components...FDA says so :)
Susan Heller Evenson : Thanks Sarah, I'll look into it more.
Sarah : your company may qualify for some exemptions under the rules
Adriana : Hi Darlene. But I am not the importer at U.S. I just export the products to retails in US. 
Bria : Mohammed: FSMA Compliance is a government regulation/law; GFSI is a certification on industry best practices
Kenly Edwards : My company exports Fresh Produce to the US based on the size of the operation we may fall into the fresh produce rule, however we have a certified Food Safety System (HACCP) do we still need to developed HARPC or can our Food Safety Plan substantiate since we have built in risk analysis and PCs
Mohammed : DARLENE..thank you
Angela : Can you provide guidance on how to communicate the FSVP requirements to our foreign suppliers?
Susan Heller Evenson : @Sarah - i think we are exept since not processing (and sampling falls under generic 'reserach samples" but hard to confirm.
kousik : If we are purchasing from a broker who is importing products from foreign land ? what are we expected to be compliant with ?
David : Do we have specific requirements for suppliers like Farmers (supplying raws food Ready to Eat) ?
Sarah : are you certified under any GFSI scheme?
DARLENE : FSVP Importer required to comply and have ready all documentation for FDA
Duane Lau : Is there a sample declaration document available?
Bria : katherine you would need to change it to comply, ISO does not have all FSMA requirements
Terina : Thank you!
Sunil Joseph : Echo
DARLENE : Lost the chats
Afton : Thank you Simon!!! Happy weekend! :)
YOUSSEF : THanks a lot Bill and Simon
Mohammed : Thanks Bria
Afton : This was a very informational presentation... and Simon rules
Jessica : There are good templates for the FSP but are there any templates for FSVP?
kousik : thanks all
Carlos : Thanks
Jennifer : Thanks for the info today! 

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Best Regards,

Simon Timperley
IFSQN Administrator
 
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