FDA Traceability Rule: Impact and Compliance
Started by Simon, Mar 01 2024 06:04 PM
FDA Traceability Rule: Impact and Compliance
Took Place:
Friday, March 08, 2024
Presenter:
Radojka Barycki, Owner and CEO, RDR Global Partners
Webinar Overview:
This webinar addresses the recent changes in traceability regulations and their implications for various industries. It would cover key aspects of the new rule, including the requirements for better tracking and recording of product journeys from production to sale. The webinar aims to inform attendees about how these changes will affect their operations, and provide strategies for ensuring compliance. It will also discuss potential challenges businesses may face and offer solutions for effectively adapting to the new regulations. This webinar is ideal for professionals in supply chain management, quality assurance, regulatory compliance, and related fields who are looking to stay ahead in a rapidly evolving regulatory landscape.
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Chat logs from today's webinar:
James Van Ells : Hello for Augusta Georgia, USA
Stephen Bulow : Good Morning Everyone
Elaine Wu : Hello Everyone from Missouri, USA
John Markan : Hello from Toledo, OH U.S.A.
Tukaram shinde : Hi
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Genevieve Fernando Fernando : Good Day everyone... from Philippines
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Jose L Vazquez Vazquez : hi from Miami
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Gavin M : Morning from Toronto!
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Angom Ocan : Good Afternoon from London Angom
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Christina Gioiosa : Good morning from Chicago! :-)
kelly Miller miller : Hello form Chambersurg
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Moha OUKRINNA : Good Morning frome Morocco
Ayobami Agboola : Ayobami Agboola from Nigeria
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Angela Suarez Fajardo Suarez Fajardo : Hello, Angela from Ecuador
Cheryl Arsenault : Hello from Prince edward Island
Michelle Strand : Miinesota
Victor Msumba : Gd evening from Tanzania-Africa
Victor N Torres : Victor, from Puerto Rico
Althea Mae Igharas : Hello from the Philippines :)
Mariela Raimondi : Hi from Argentina
Vipin Singh : Vipin from India
Teresa Lamela : Hi from Portugal
Cole Bennett Bennett : Cole from north carolina
Todd Larson : Chicago
Jude Leke : Good morning from Toronto
Mary Paulson : South Carolina
Christabel Aryee : Hello, Christabel from Ghana
Christina Gioiosa : It's rainy and miserable in Chicago today, haha
Horacio Tomasini : Hello from Argentina
Johnny Strickland : Hello from North Carolina
Juane Jooste Jooste : South Africa
Navneeth Asthana : Hi, Navneeth from India.
Muhammad Altaf Altaf : Currently in Philippines
Nancy Rood : Seattle, WA
Ying Fu : Hi everyone from Toronto
Kevin Sexton : Good morning from North Carolina!
alejandra Martinez Martinez : Hello from California!
sanjeewa kumararathna : good night sri Lanka
Christy Young : Good morning from Edmonton, Canada
Samar Kamar : Hi from Stockholm Sweden
Sovi Chawla : Cananda
Ehihumeme Afeisume Afeisume : Meme from Nigeria
Tukaram shinde : Tukaram Shinde from India
Camilo Trejos : Hello From Tampa Florida
Maxine CAMPBELL : Maxine fr Janaica
Mohammad Hussam AL Shikha : Mhd Hussam AL Shikha, Iraq, Hello every body
Channarong Sontipunsak : Hi from Thailand
ARUL KUMARAN J : Good afternoon everyone
Maureen whann : Los Angeles, California
Franklin Dalisay : Franklin from the Philippines
Muhammad Shahid : Hi dear. From Pakistan
Jacob Okpongete : Hi good evening, Jacob from Nigeria from
Tukaram shinde : Hello everyone, I am Ramesh from India
Marina Rusli : Hi all. Greetings from New York!
Dorothy Albertsz : Hello from Aruba
John Tugcu : Good morning from Miami
Mike Rubicini : Good morning from Ontario, Canada :)
Jorge Siller : Jorge from México
Kenneth Ruiz : Greetings from Aruba
Priyadarshini Perera : Hi I am Priyadarshini from Sri Lanka
Robert Sarabia : Good morning from Michigan
Stella Obeng : Good morning from Ghana
Adriana Camacho : Adriana Camacho from Mexico
Sathish Kumar Babu : Hello Everyone, This is Sathish from Western Canada
Tukaram shinde : Ramesh from India
Brenda Stahl : Hi From DC!
Sushant Salunkhe : Hi from India...ðŸ™
Gabriela CASTILLO : Good morning from California
Herlinda Velazquez : hi, from Corpus Christi, TX, USA
YOHANNES WONDIMU TEDLA TEDLA : Yohannes from ethiopia
Tausi Abdul Mkalimoto : Hello everyone,Greetings from Tanzania.
Guadalupe Arzola Arzola : Guadalupe from Chicagoland good morning
debora pinho cordeiro : Greetings from Vancouver, Canada
Bruce Perkin : Other than changing suppliers, what recourse would an operator have should a supplier not provide the data required?
Pete Mitchell : Good morning from New Mexico!
Risper Kiaye : Hold Risper from Kenya
Risper Kiaye : Sorry Hola
JANET DELIGERO : Hello from Philippines but now in Madagascar
Irina González : Hi,Good morning, from Puerto Rico
Hayat JAADAN : Good morning , Hayat JAADAN from Argentina
Samantha Lynch : Exactly what does our supplier need to supply us, does it need a specific format, a specific name, etc. and does it need to be communicated in a specific way? Does the supplier need to be aware of the new rules or can they be compliant without knowing? I.e we may purchase from a supplier that doesn’t ship to US directly.
Kenza AMEZIANE HASSANI : Kenza Ameziane Hassani from Morocco
Jatinder Bhamra : Hello, Good Evening from India
Jose L Vazquez Vazquez : Hi from sunny Miami
Nagah Hafiz : Hi every one
Tran Thi Huyen Trang Tran Thi Huyen : Hi from Trang- Vietnam
Javier Diaz : Good morning from California
Walter Major : Good morning from New York
Issa Beitouni : Hi from Jerusalem
Divina Grace Barroso : Hi from Manila Philippines!
Angie Angie : what platform should be used to collect info from the suppliers upon receipt on product??
Carmen Sava : Hi everyone, greetings from Canada
Sefiu IKUDAISI : Hello to everyone from Nigeria
Mwangelwa Charles Matongo : Hello Charles from Zambia
LaMont Campbell : Good Morning from St. louis, Missouri!!
Wiam Chariji : Hi please i want to have mor information about fda chechkist
Jorge Manzanero : Morning to all from Belize.
HORCHELLE TOUKAP DJOMPTCHOUANG : Good afternoon from Cameroon
Cindy Halbleib : Good morning from Pennsylvania.
Kristine Mae De Guzman : Good evening from Philippines
Anand Varghese Thanikkal Thanikkal : Hi , is there any time period for storing the daily production check sheets, like end of the shelf life of the product or till one care, irrespective of the product shelf life?
debora pinho cordeiro : Does FDA provide a template for this Sortable Spread Sheet?
Noel Martin : Good morning from Bermuda
Angie Angie : Does each supplier need to provide us with their GLN number?
Anand Varghese Thanikkal Thanikkal : Is there any time period to store the daily production checksheets, considering the product shelf life or like and year, two year etc?
debora pinho cordeiro : For those who do not have any software (only paper), this sortable spreadsheet is also mandatory?
Ian Allan Lambert : Good day everyone. Ian from Dominica
Bryan Reynolds : If a fresh fruit is included in a product that is frozen as part of the manufacturing process and then baked by the store does this fresh ingreedient have to be tracked?
fredeswinda Justol : Good day
joe kebr : hello from Chicago
Dustin Daniels : peanut butter cups are exempt even though they contain a nut butter?
Bryan Reynolds : Does freezing a final product that includes peanut butter remove it from tracking requirements?
YOHANNES WONDIMU TEDLA TEDLA : Can we Trace biscuit product at CCP point
Samantha Lynch : Can we get a copy of this presentation?
muhammad Atif : i am atif here .Please email me Atif@mbasolutions.co
debora pinho cordeiro : WRITTEN AGREEMENT - and about raw flour? The Kill Step is done by the "Costumers", so how to have this agreements? It is enough to add this information to the product packages?
muhammad Atif : how can i become an FDA Consultant
ATANDI Komi : Comment devenir consultant de CFA ?
Mary Silveira : As importers, what are the responsibilities related to the traceability rule? Is it the importer's responsibility to guarantee that the supplier is complying with this rule?
Muhammad Altaf Altaf : Can you explain how blockchain record the data in value chain to facilitate traceability?
Cole Bennett Bennett : Thank you Radojka! Great job
R Ko Din Ko Din : Thank you and great presentation
Nicholas Ng : Thank you
Emili Darrow : Thank you!
Emili Darrow : Great webinar
Wiam Chariji : Thank you
Dora Zhang : will this training video record be available?
Victor Msumba : thanks
Angie Angie : Where can we find a template for the Sortable Excel Spread Sheet?
John Markan : Thank you!
Genevieve Fernando Fernando : STORABLE not sortable
Muhammad Altaf Altaf : Can you explain how blockchain record the data in value chain to facilitate traceability?
Gabriela CASTILLO : The food traceability rule mentioned fresh tomatoes but we receive tomato paste from our suppliers. Do we fall under this rule?
KADI Farid : Thank's a lot
Dustin Daniels : Will FDA require maufacturers to have a scannable lot code for distributors. I am a large distributor and the notion of keying in lot codes will be cripping to business
ROSA GOMEZ : Will this session be emailed to us? for training purposes.
Sathish Kumar Babu : Should the Traceability process should be inline with GS1 standards?
Muhammad Shahid : Thank you for providing the opportunity to attend this nice webinar...
Michelle Riebe : Use feta and blue cheese in our dressings. We already use lot codes and tie them to the finished product. What else different do we need to do?
Stella Obeng : Is the traceability task at the end the work of the QA team? Because mostly the auditors expect the QA to have all the documents on traceability from beginning to the end
ROSA GOMEZ : Will this session be emailed to us? for training purposes
Moha OUKRINNA : What does ingredient traceability entail, and how does it ensure the tracking of each ingredient's origin and journey from source to final use in product manufacturing?
Dora Zhang : if we sell meals received from restaurants do we they subject to the traceability rule?
muhammad Atif : when ever i apply on FDA its ask local agent for registration ?how can i resolve it because i am from Pakistan.
Mohammad Hussam AL Shikha : so I understand that mandotary documents of traecebility are (plan- TLC- CTEs- KDEs- Testining reports- internal audit...) what is else ?!
Angie Angie : Does each supplier need to provide their GLN number?
Desireth Kock Kock : Sometimes supplier doesn't provide enough product information at the package example: use by dates. How important is to receive this type of informations
Anthony Maldonado : If mutiple lots come on a pallet of product (lets say apples), is each lot and quantity required to be segregated and documented?
YOHANNES WONDIMU TEDLA TEDLA : It is very interesting and important
debora pinho cordeiro : WRITTEN AGREEMENT - and about raw flour? The Kill Step is done by the "Costumers", so how to have this agreements? It is enough to add this information to the product packages?
John Markan : Dora Zhang has an interesting question!
Marco Identici : Thank you to all
Divina Grace Barroso : Thank you.
Marco Identici : Have a Nice weekend
Nagah Hafiz : Thank you so much
HORCHELLE TOUKAP DJOMPTCHOUANG : In case my product is further transformation does my reponsibility stop at the next element of the supply chain?
Dora Zhang : if we sell meals received from restaurants do we they subject to the traceability rule?
Girma Masresha : Thank you
Roy Martin : ðŸ˜
Genevieve Fernando Fernando : Thank you so much for interesting Q&A portion
Rick Reyes Reyes : Thank you so much for this training.
Cole Bennett Bennett : dog
Hannah Franco : Thank you!!
Luisa Gonzalez : THANK YOU!
Gabriela CASTILLO : tomatoes (fresh) are listed on the list. We received tomato paste and dehydrated. Does this rule applies to us?
Janvi Sharma : Thank you
Angie Angie : At the customers end, do KDEs need to be provided with each delivery?
Anthony Maldonado : thank you
Angie Angie : We manufacture fermented vegetables/pickles, are we subject to the rule?
HORCHELLE TOUKAP DJOMPTCHOUANG : Thank you for the interesting discussion 😄
Michelle Riebe : We are a manufacturer. Do we have to supply the distributor the lot of the raw material used in the finished product or just our finished product lot code?
Robert Sarabia : Thank you
Muhammad Altaf Altaf : Thank you ðŸ’
Prasert Setwipattanachai : Thank you very much.
Adebola Sokabi : Thank you
Bev McKnight : Thank you, great presentation!
Gavin M : Thank you !!!
Ron Hare : Thank you!
Wiam Chariji : Thank you
Kelli Mascaro : Thank you for this great presentation!!!!
Mayank K Joshi Joshi : Thank you
Angela Suarez Fajardo Suarez Fajardo : Thanks , Great presentation
Carmen Sava : thank you
Caron Celine : Thank you
muhammad Atif : Thanks
Mohammad Hussam AL Shikha : Thank you very much
Risper Kiaye : Thank you
Navneeth Asthana : Thank you
Dorothy Albertsz : Thank you
Is anyone else struggling with the FSMA204 Final Rule regulations?
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FSMA 204 Final Rule
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