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Validation of Microbiological Control Measures

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#1 Simon

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Posted 11 September 2020 - 06:12 PM

Validation of Microbiological Control Measures
 
Took place:
Friday, October 02, 2020. 
 
Presenter:
Wilfredo Ocasio, Senior Director, Food Safety Research, Eurofins Advanced Microbiology
 
Webinar Overview:
Validation of control measures is a core requirement of the Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls for Human Food (PC Rule, 21 CFR117 Subpart C) under the Food Safety Modernization Act (FSMA). However, in many applications the concept of validation as required by the PC Rule remains unclear and presents a serious challenge the food industry in its efforts to comply with the new regulations. This is particularly evident as it pertains to the validation of “kill-steps” intended to prevent or mitigate microbiological hazards. While validation of thermal processes such as pasteurization of milk products (under the Pasteurized Milk Ordinance) or canned, low-acid, shelf-stable products (under 21 CFR 113) enjoy the benefit of well-established validation protocols, other products/processes such as those involving low-moisture foods (e.g., dry pet foods, dry pasta, tree nuts, baked goods, etc.) often receive thermal processes which have not been fully validated but are claimed as “kill-steps” in existing HACCP programs.
 
This presentation aims to provide a clear definition of the concept of validation, distinguish it from the closely related requirement for verification and illustrate strategies to complete this regulatory requirement. Emphasis will be given to the interventions aimed to achieve the required reduction of microbial pathogens in relation to low-moisture products, acidified foods and novel technologies such as high pressure pasteurization.
 
 

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#2 Simon

Simon

    IFSQN...it's My Life

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  • United Kingdom
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  • Gender:Male
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  • Interests:Married to Michelle, Father of three boys (Oliver, Jacob and Louis). I enjoy cycling, walking and travelling, watching sport, especially football and Manchester United. Oh and I love food and beer and wine.

Posted 02 October 2020 - 05:52 PM

Chat logs from today's webinar:

 

Premchand Thombare : Hello  everyone from India
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Wilfredo Ocasio : hello
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Michael Greene : Hello
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MUHAMMAD HASSAN SHAHZAD : Good evening Hassan from Alhassa KSA Alkifah Paper Products Co
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Jose Chipollini : Good Morning from Northwest Arkansas!!
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Grace B. Membrebe : Hi! Grace from the Philippines
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Silvia Michanie : hi, from Buenos Aires
Rossana Oropesa : Hello everyone, from Lima-Peru
Sarah Muncy : Hi from Ohio, USA
Richa Kalia : Hi, from Woodstcok, ON, Canada
Jan Jackson : Good morning from North Carolina
Amanda McIntosh : Good Morning from Amarillo, Texas!
Rene Pagatpat : Hello from Philippines!
zeina nakat : hello from Lebanon!
Jema Ajanwachuku : Hello from Llagos, Nigeria
Mary Parks : Greetings from North Carolina!!
Corina Burada : hello from Romania
Shantnu Gupta : Hello
María Fernanda Bello Pinargote : Hi from Ecuador
Yenisha Senaweera : Hello everyone
Irfan Gul : Hello this is irfan Gul joined from pakistan.
Jazmin Villarreal : Hello from Mexico
Sunil Joseph : Hello
Tran Thi Huyen Trang : Hi from Vietnam
SHARON ROSE : Hello from Trinidad and Tobago
Sabina Alexander : Good Morning
Gibe Justine Jalinon : Good evening from The Philippines
Yvette Bryan : Hi from Jamaica
Irfan Gul : How much moisture content affect on vegetable specialy which are refregrate?
Nilesh Bhalekar : Hi
Dawn Remmel : Greetings from Waupaca, Wisconsin, USA
simon timperley : Please save your questions  until after the presentation
Muhammad Shoaib Yamin : Hi
Dr. Ahmed El-Mesallamy : Hi from Al-Azhar University, Egypt
Lakshmanan S : Hi
Muhammad Shoaib Yamin : Muhammad Shoaib Yamin from Pakistan
Yehia El-Samragy : Hi everybody
Sudhir Kalsulkar : Hi
Michael Moyo : Is there a set frequency on the ISO22000:2018 Standard on how often one should validate their CCPs or Control measures?
Suman Saurabh : Suman Saurabh from India
Melaine King : Hello
BHISE NARAYANRAO : Hi... from India
Suman Saurabh : Hi everyone
Nilesh Bhalekar : Hi everyone
Sarah Nelson : I think the volume cut out?
Vincia Wilson : Hello, I am from India
Dianawati Dianawati : Hi everyone, Diana from Jakarta Indonesia
Kimberly Donald : Hello from Texas!
simon timperley : If you lose audio or visual click RECONNECT
Penny Walker : Hello from Arkansas!
Willem Tjitrotaroeno : Good day..From Suriname
Craig Bahn : Hello
NELIUS NYAMBURA : okay Simon Timperley
Chandrashekhar Shah : Good evening from Pune, India
abdelhamid Meziani : HI from Montreal
MUHAMMAD HASSAN SHAHZAD : But one of validation approach to do research or consider research literature? As per CODEX VALIDATION GUIDELIENE is it not??
Maylene Lenizo : Hello from Philippines
Tiffany Grace Conol : Good evening from Philippines
Olubunmi Osiyoku : Hello from Nigeria
Nestor Carrizosa : Hello from Mexico
Alejandro Becerra : hello from Texas
Marija Peric : Hallo aus Österreich
NELIUS NYAMBURA : HACCP is a validation approach?
Chandrashekhar Shah : If re-validation is not done as per the potential triggers shown in slide No. 13, can we raise as a major non conformance during the audit?
Rossana Oropesa : if nothing changes in the operation / control measure, for how long could a validation be valid to be considered? does it has to be performed every start of a new season?
Cindy Chin : can show subtitle?
simon timperley : No sorry Cindy.
Julieta Rustrian : I loose the conection
Chandrashekhar Shah : Graphical analysis slide is not visible properly, cant read clearly
Joseph Klu : Joseph joining from Accra, Ghana
Youssef OUACH : Hello from Casablanca
Muhammad Shoaib Yamin : Hello from Pakistan
Vickie Lewandowski : Your technology examples (HPP, etc) really illustrate the need for specific expertise for validations, expertise way beyond that of the average PCQI.  Do you think the FDA needs to rethink the statement indicating that this is the PCQI's responsibility?  Some smaller companies may only have PCQIs at the facility (QA manager) and not at a corporate level.
Sarah Kerubo : Hi  from Kenya
Hellena Wanzala : Hi from Uganda
Penny Walker : Vickie Lewandowski, do you think they want us to have PCQI trained individuals at the corporate level?
Igor Angelovski : now is ok
Abubakar Wakibi : Heloo, from Uganda here
Bruce Perkin : Penny and Vickie, the location of the person is not the key. What is important is that the PCQI is "qualified" to complete the tasks that they are responsible for. Yes if you have a HPP process, the expectation is that the PCQI will have appropriate training, education or experience in HPP
NENE OBIANWU : Hello everyone, from Nigeria
Fayez Ahmad : Hello from Riyadh Saudi Arabia
Anabella Bosque : hi everyone'
Geoffrey Mbuguah : Geoffrey Mbuguah from Nairobi Kenya.
atefeh nekooamal : I have a question about eurofins laboratory, do your company have ISO 17025 certification?
Jose Chipollini : Please define Legacy Equipment
Penny Walker : Thanks Bruce
Chandrashekhar Shah : Correct BRUCE
Silvia Michanie : Very good expositor!!!!
Lori Tansey : will the presentation be recorded and available? or the presentation only?
Sarah Kerubo : How can you control Listeria in high moisture products I.e runner beans
Shameena Baksh : Excellent. Thank you.
Emilie Musson : If a facility places spices, dried vegetable matter, etc. into buckets and fills the buckets with hot water as a treatment for the  inclusions, would you please explain what would need to be done to validate the process and can you give us an example of what a proper validation would consist of?  What would be the verification/monitoring activities for this process?
Vickie Lewandowski : Bruce, I'm thinking of a facility that incorporates a micro sensitive ingredient, post lethality.  That facility does not have an HPP process,  they just know that the supplier needs to apply the process control.  They are likely not experts in control of pathogens in low moisture foods.
Vickie Lewandowski : Hi Emilie Musson!
Emilie Musson : Hi Vickie!
Lori Tansey : Validation (challenge studies specifically)  is typically best completed by an unbiased accredited lab.  Can you make some comments around this.
Nathalie Lyonga : hi Kimberly!
Bruce Perkin : Vickie, the PCQI is the person who signs off on the process ability to control the hazards. Therefore for that process that PCQI needs to have education, experience or training that allows them to have the capability applicable to that process.
Penny Walker : What do you all think of Salmonella testing on powder ready to drink product?  Did decision tree and inconclusive.  Know kinda off topic, but company specific.
Emilie Musson : Vickie, reach out sometime, I'd love to hear from you
Valerie Cote : Vickie Lewandowski - Then the PCQI needs to be able to recognize that he/she doesn't have the expertise and makes sure an expert is brough into the team (could be 3rd party).
Lori Tansey : Please comment on micro modeling that is available that could be investigated and used if appropriate.
Penny Walker : I guess my question was not off topic...any replies?
Anabella Bosque : Did this webinar started earlier than scheduled? In the website it says fpr  my time zone it was supposed to start 11:00AM ET but it started 10:30 AM ET I missed the first few min
Bruce Perkin : Penny, it depends on the raw materials and how you are handling them
Muhamad Najib Nur : Thanks for sharing
SHARON ROSE : On Slide 37, if the surrogate is behaving differently than salmonella, how can it be a good subsitute for Samonella and give reliable results?
Chandrashekhar Shah : Anabella - I think they will share by email recorded presentation
Vickie Lewandowski : When there are outbreaks with a new or rare strain, are surrogates reevaluated against those?  I'm wondering about the recent Salmonella outbreak in onions, any concern with current validated processes for dried/dehydrated onions?
Anabella Bosque : thanks Chandrashekhar
Camila Brossi : In a validation process do we necessarily need to use surrogate microorganisms? or can we just rely on product regular  lab tests?
John Edwards : That was very useful, thank you
yiyi liu : E. faecium is less heat resistant than Salmonella at tempeteraure higher than 78F, does that mean we have to choose another surrogate for that temperature range?
Sarah Muncy : Sharon, the presenter was making the point that surrogate suitability must be validated, as surrogate organisms may behave differently from their represented organism under certain conditions.
Rancy Sharma : Is it worth to do any validation if no pathogen risk is present at starting point only?
Dr. Ahmed El-Mesallamy : Thank you for great persentation
Anabella Bosque : one of the slides mentioned Salmonella has higher resistant at low wA, can you explain why is that?
Maria Felina Espiritu : Very informative presentation. thank you
Allan Hernandez : Thank you, great presentation!
Anna Lorraine Pobadora : What is the recommended target microbial load reduction when validating a cleaning method applied to say that it is effective....
Atil Gedik : For validation do we need to use simulant of related m.o.
SHARON ROSE : Thanks Sarah Muncy - understood. I must have missed that point. Thanks you for the clarification.
Kafayat Adebayo : Hello, Kafayat Adebayo from Nigeria
Md Nasir Hussain : any frequency for validation
Chandrashekhar Shah : Thank you so much for taking my question.
Rebecca Ko Din : Thanks to Simon and Wilfredo! Stay healthy and safe! Have a wonderful weekend to all!
Sarah Muncy : Sharon Rose- you are welcome!
Norman Tarbell : You need to address the Major non-conformance audit issue with your certification body
Premchand Thombare : Excellent  presentation  & explanation  too  Thanks to both of you.ðŸ‘✌🙂
Elisma Van Zyl : Why would a consumer complaint trigger a revalidation? Why not start with a verification?
Marvi Cilli : What about over time, if your pasteurizer ages?
Sujit Kumar : What is prospective validation and retrospective validation, which is more important?
Penny Walker : Bruce, accourding to the decision tree I don't need EMP because the ingredieants are not RTE, but the product is RTE...Ready to drink after water added...
Hellena Wanzala : In the case of an organization that does catering, how would validation of the microbial control measures look like in order for it to be adequate especially when venues of serving change (i.e. customers)?
Rose Kwan : Food regulations require pathogens like Salmonella to be negative in the finished food products. What is the appropriate validation for this?
Muhammad Altaf Altaf : What are the changing factors that will not impact on control measures validation?
maria luisa Chillida : Hi from Spain
Anabella Bosque : Thank you for your time and informative presentation!
Muhammad Akhlaq : Great... And informative..
Bruce Perkin : Penny, if all the consumer does is mix with cold liquid and drink, then there is no kill step, and the powder would be considered RTE
arpan bhagat : What should be specific requirements for validation for foreign suppliers who are exporting to US and may not follow FSMA ?
Julius Lara : Do you recommend using an outside firm like Eurofins to perform a Validating study?
Marvi Cilli : What is the surrogate normally used for Listeria monocytogenes?
Elisma Van Zyl : Penny, have you considered doing a challenge study on your RTE product and using those results to decide?
Bhanu Sudhakar : Is verification also a Validation?
V C : Question: Any good guidelines on Clostridium botulinum challenge studies in bakery products with modified atmosphere packaging
Greena Tino : How this validation could be documented"
atefeh nekooamal : what are direct methods to eliminate microbial parameters of food products(pistachio)?Are ozone or unization (activatek products)effective?
Maria Lourdes Abularach : Good morning. Maria Lourdes from Bolivia
Greena Tino : How this validation could be documented?
Margaret Pollard : VC I'm not aware of any good guidlines but C Bot and Bacillus cereus needs to be considered!
Grisel Leon : What pathogen should be monitored in a coffee plant ?
Lakshmanan S : Validation requires every year even no change in control measures
Greena Tino : Q
Riaz Ahamadeen : How we control Bacillus Cereus Vegetative Cells & Spores in Food ingredients and RTE Foods and also how critical is B Cereus threat in Yoghurt or Cultured Products?
Penny Walker : Elisma, I have not considered a challage study.  To do that I would think I would need the samonella plates for testing and we have not had enough reasurance in doing salmonella testing to buy the salmonella plates.  I know just about $60, but we are a small business.
Kirsten Sullivan : If following the recommendations of a process authority, do we still need to validate?
Margaret Pollard : How do you find the microbial loading of ingredients when they are forever changing ?
Vickie Lewandowski : Emilie Musson, I sent you a message a while ago, check your junk/spam email
Simran Kaur : Is it necessary to include contamination indicator organisms as a part of raw meat shelf life validation?
Larissa Wilke : in the last time we receive the requirement of salmonella absent in 375g - is this a new legal requirement in the us?
arpan bhagat : Thank you for the question Emilie Musson. Hello Vickie.
Md Nasir Hussain : great webinar
Muhammad Shoaib Yamin : Certificate?
C Davis : When scientific data isn't available for a product and a lab capable of performing the study isnt readily identifiable; can you try mathematical modelling?
Sarah Muncy : Great webinar, lots to think about!  Thank you!
Su Myat : May I know what kind of microorganisms can grow in 40 percent whisky.
Penny Walker : Thanks for all your input, I feel confident in not doing Salmonella testing for EMP.  Our finished product testing is adequate.
Jose Chipollini : Excellent presentation WIlfredo. We hope to see you again in this forum.
Bruce Perkin : Hey Simon, this has been a very good webinar - you will have to invite this speaker back for a another go around!
John Tran : Thank you very much for the excellent presentation.
DONNA JOY ESCALANTE : What are typical examples of surrogate organisms for salmonella?
Vickie Lewandowski : Thanks for taking my question Wilfredo.  Good to see you, hope you are staying safe and healthy!
Carl Dave Mendoza : How many times do you need to perform validation for the control measure to be considered a validated?
Sabina Alexander : This has beena  very good Webinar. Thanks Simon and Wilfredo.
Nasrin Mpour : Hi , Nasrin from Toronto
Anne Marie Casullo : Thank you so much for this fantastic webinar. Learned alot.
Greena Tino : What are the challenges that we can expect du
Nathalie Lyonga : You mentioned Validation test parameters must represent  worst case scenario. could you expand more on that?
Rancy Sharma : Thank you so much.
Sabina Alexander : Thanks also to Bruce, Penny, Valarie, and Elisma. I got some things to bring up with my team from your discussion.
Greena Tino : What are the challenges we can expect for this validation for  environment pathogen monitoring program for food manufacturing industry
Anabella Bosque : thank you! good comparison example to understand the difference between dry heat and wet heat
Chandrashekhar Shah : Can somebody tell, how to add our name in certificate template after downloading ?
PARADORN TEPPARNICH : How to validate fresh fruit&vegetables package product
Mariana Shivacheva : THANK YOU SO MUCH FOR THE EXCELLENT PRESENTATION!!!
Bernardo Clavijo : It was a great presentation, thank you Wilfredo
Sabina Alexander : @ Chandrashekhar: Print and sign is one way
Greena Tino : How to add name in certificate
Nathalie Lyonga : one of the slides mentioned that validation test parameters must represent worst case condition. can you expand more on that?
Margaret Pollard : Thank you for a great presentation
Chandrashekhar Shah : Thanks Sabina ! but the template is not editable
Martin Terminel : Great Presentation! Thank you! Have agreat Weekend!
Mastaneh Dalili : Thanks a lot for the presentation!
Rancy Sharma : Can we get these slides and recording? It is very helpful.
Lakshmanan S : How to add my name in certificate
Sabina Alexander : I also Copy and Paste into word and add my name by adding a text box over the space for name
Noah Bogosia : Is a HACCP Plan technically correct to reference a regulatory specification for cooking (time/temp) as their validation method??
Ajay Sahota Sahota : Kindly suggest how to treat low activity product like flours to make them Microbiologically safe?
Jennifer Aquart : Very good and informative presentation. Thank you.. Stay safe.
Maria Lourdes Abularach : Has been ozone validated for any product, as a killing step?
lakshmikanth, G R : how to add name in certificate
Mohammad Amin Hanifpour : this is also my question, how to add name  in certiificate?
SHARON ROSE : Dried coffee would need to be monitored for molds since mycotoxin production can occur
Nestor Carrizosa : Thank you!
Chandrashekhar Shah : Ok, finally I was able to put my name in certificate. Please open this template (PNG file) in paint brush and then add your name and save again. its very simple. Thanks a lot!
Simone Kummerlöwe : Thanks for the great presentation
Sabina Alexander : Chandrashehar, I'll have to try that today.
lakshmikanth, G R : what are the micribial activity in mango beverage(NCB) to be the water pulp seperation like emulsion?
Chandrashekhar Shah : Sabina, Mohammed, Laxmikanth... please open file in paintbrush and add your name and save
Adrian Kirton : Thank you to all. Very informative and competent presenter.
Emilie Musson : Agreed!!
NELIUS NYAMBURA : For certificate the download is not possible
Michelle Millan : thank you for the great webinar
Tanja Baker : Great presentation. Thank you. Have a lovely weekend
Bethan Rowlands : Great webinar, thank you!
Kirsten Sullivan : Thank you so much for the answer on Process Authority -- Excellent presentation!
Anabella Bosque : agreed! with some case studies will be great
Ana Dema : thank you. Excellent topic and presenter
Jennifer Aquart : I agree with inviting him back.
Nazish Usmani : Thank you so much Mr speaker:)
Klee Wiles-Pearson : thank you
Christina Stark : Excellent Presentation!!!!
Michael Greene : Thank you very much for all the information. Great Presentation.
Bill Brochin : absolutely great.  Thank you
vicky garcia : Very substantial and relevant presentation. thank you very much, will email Sir Wilfredo.
Julius Lara : THANK you so much for everything
Maame Esi Nkrumah : Great presentation. Thank you
Peggy Galloup : Fantastic webinar
MUSAED ALSULTAN : Great presentation
Marlene Ramirez : Thank you!
Gail Nixon : Thank you. Great speaker, moderator, questions!
Mary Parks : Great Great Great!! T
Kafayat Adebayo : Great presentation
sundus alshehabi : thank you alot
Dr. Ahmed El-Mesallamy : thank you all
Chandrashekhar Shah : Thank you so much for such a wonderful presentation and training. It is of great help. Thank you so much! Take care all of you
Noah Bogosia : Thanks Simon & Wilfredo!
RAY ARCILLAS : thank you!..
Julius Lara : Thanks for providing this service
INNOCENT DJOSSOU : Merci beaucoup
Jayesh Gopal : Thank you Great effort
atefeh nekooamal : thank you very much!
Muhammad Altaf Altaf : Dear Mr Simon, I will recommend DIFSC management to invite this speaker in next conference. He is a great scientist in control measures validation.
Bernard Lee : Thank you~
KEE KEE GOH : Thanks Simon, have a great day

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