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❖ ProFOOD Consulting LLC. ❖ www.profoodconsulting.com ❖ [email protected] ❖ ❖ Tel. +1-954-829-6395 (USA) ❖ Fax +1-888-886-2655 (USA) ❖

DATE & VENUE:

MAY 22-24, 2017 BERLIN (GERMANY)

FDA FOOD SAFETY MODERNIZATION ACT (FSMA)

PREVENTIVE CONTROLS FOR HUMAN FOOD TRAINING

***FDA RECOGNIZED TRAINING FOR PCQI*** This course is approved by the Food Safety Preventive Controls Alliance (FSPCA), the only curriculum recognized by the FDA. The standardized curriculum is designed to meet the training requirements under Title 21 Code of Federal Regulations Part 117.115 for the "preventive control qualified individual" who conducts certain Food Safety Plan activities.


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DO YOU EXPORT FOOD TO THE UNITED STATES? ARE YOU PREPARED FOR NEW FSMA REQUIREMENTS FOR ENTRY AND CONTINUED ACCESS TO THE U.S. MARKET?

PROFOOD CONSULTING INVITES YOU TO ATTEND THE ONLY TYPE OF FDA RECOGNIZED FSPCA PREVENTIVE

CONTROLS FOR HUMAN FOOD COURSE IN GERMANY TO MEET THE FSMA REQUIREMENTS FOR FOOD PROCESSORS. IF YOUR COMPANY EXPORTS FOOD TO THE US, YOU SHOULD VERY LIKELY MEET THE FDA FSMA REQUIREMENTS. FSMA IS THE NEW USA REGULATION FOR PREVENTIVE CONTROL OF HUMAN FOOD. IT IS INTENDED TO ENSURE THE

SAFE MANUFACTURING, PROCESSING, PACKAGING AND HOLDING OF FOOD PRODUCTS FOR HUMAN CONSUMPTION IN

THE UNITED STATES. AS AN EXPORTER OF FOOD TO THE US YOU ARE SUPPOSED TO MEET THE SAME REQUIREMENTS AS US DOMESTIC

COMPANIES. EXPORTERS SUBJECT TO THIS RULE MUST ENSURE THAT THEIR FOOD SAFETY SYSTEM IS DEVELOPED AND

APPLIED BY AN INDIVIDUAL (PCQI) WHO HAS SUCCESSFULLY COMPLETED TRAINING IN THE DEVELOPMENT AND

APPLICATION OF RISK-BASED PREVENTIVE CONTROLS. PROFOOD IS PROVIDING A VARIETY OF COMPLIANCE SOLUTIONS THAT YOU CAN INCORPORATE TO SUIT YOUR NEEDS IN

REACHING CONFORMITY WITH THE NEW FDA REGULATIONS AND CONTINUE YOUR EXPORTS TO THE USA WITHOUT ANY

INTERRUPTIONS

• LEARN ABOUT THE FSMA REGULATIONS AND WHAT THEY PRACTICALLY MEAN TO THE EXPORTERS;

• GET CERTIFIED AS A PREVENTIVE CONTROLS QUALIFIED INDIVIDUAL (PCQI)

• BE PROVIDED WITH THE KNOWLEDGE YOU NEED TO DEVELOP/ADAPT YOUR FOOD SAFETY MANAGEMENT SYSTEM TO MEET THE NEW AND ENHANCED FDA REQUIREMENTS.

• IMPROVE YOUR ABILITY TO SPEAK THE SAME FOOD SAFETY LANGUAGE AS FDA DOES.

• TAKE ADVANTAGE OF THE KNOWLEDGE AND HANDS-ON EXPERIENCE OF OUR TEAM IN SOLVING ALL YOUR FSMA COMPLIANCE CHALLENGES, SYSTEM IMPLEMENTATION, PRODUCT VERIFICATION OR LEGAL COMPLIANCE.

• GET AHEAD OF YOUR COMPETITORS BY TAKING A PROACTIVE APPROACH TO MEETING THE REGULATION REQUIREMENTS AND KEEPING YOUR CUSTOMERS AND IMPORTERS IN THE US RELAXED AND ASSURED ABOUT YOUR FSMA COMPLIANCE.


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Training objectives:

This FSMA Preventive Controls Qualified Individual training course was developed by the Food Safety Preventive Controls Alliance (FSPCA) and is the “standardized curriculum” recognized by FDA. This course is specifically designed to follow the requirements set forth by the US Food & Drug Administration (FDA) to meet Food Safety Modernization Act (FSMA) criteria for Preventive Controls Qualified Individual. As an essential role within a food processing facility, the preventive controls qualified individual is crucial to the management and preparation of the food safety plan, validation of preventive controls and more. Companies subject to this rule must ensure that their food safety system is developed and applied by an individual who has successfully completed training in the development and application of risk-based preventive controls. As a leader in professional training, we offer you unrivaled expertise in the requirements for becoming a preventive controls qualified individual, as well as in-depth knowledge of the standardized curriculum recognized by FDA § Learn and implement the requirements and responsibilities of a “Preventive Controls

Qualified Individual”, which include: o Preparation of the Food Safety Plan o Validation of the Preventive Controls o Records Review o Reanalysis of the Food Safety Plan

§ Learn and understand the key requirements of the Preventive Controls Rule of the FSMA § Identify and implement the key requirements to be prepared for an FDA inspection

Course content:

§ Food Safety Plan Overview § Good Manufacturing Practices and Other Prerequisite Programs § Biological Food Safety Hazards § Chemical, Physical and Economically Motivated Food Safety Hazards § Preliminary Steps in Developing a Food Safety Plan § Resources for Food Safety Plans § Hazard Analysis and Preventive Controls Determination § Process Preventive Controls § Food Allergen Preventive Controls § Sanitation Preventive Controls § Supply Chain Preventive Controls § Verification and Validation Procedures § Record Keeping Procedures § Recall Plan § Preventive Controls Rule Overview


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Audience profile:

This course is aimed at those seeking to meet the training requirements for the PCQI, including: § People seeking a way to demonstrate regulatory compliance, having a PCQI within their

organization § Organizations exporting to the USA (see exemptions on the FSMA website

http://www.fda.gov/Food/GuidanceRegulation/FSMA ) § Food Safety Team Leaders § Quality Managers and other Managers involved in the Food Safety § Consultants § Personnel responsible for Regulatory affairs § Food Safety Auditors

Prerequisites:

Prior knowledge in GMPs, HACCP and experience in Food Safety Management systems is highly recommended.

Dates and Location:

§ MAY 22-24, 2017 - BERLIN (GERMANY) § We can also organize intra-company courses on request. Please contact us to have more

information ([email protected])

Registration information:

§ Duration: 2.5 days: o 22/05/2017 - 8:30 -17:00 o 23/05/2017 - 8:00 -17:00 o 24/05/2017 - 8:00 -12:00

§ Language: English § PRE-REGISTRATION

o Seats are limited, please pre-register for the course until May 1st , 2017 at www.profoodconsulting.com or by clicking HERE

o Please note that the training cannot take place with less than 10 participants. o In that case the ProFOOD reserves the right to change the date for the training.

http://www.fda.gov/Food/GuidanceRegulation/FSMA

mailto:[email protected]

http://www.profoodconsulting.com/

https://form.jotform.us/71094774884167


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Course Fees

§ 1050 (EUR); 1100 (USD); o (VAT is not charged - Reverse Charge as per EU Directive 2006/112, Art. 196).

§ Credit Card payment (USD) can be made on our website: www.profoodconsulting.com § For Wire Transfers, email us at [email protected] § Included in the price:

o Course delivery by a Lead Instructor for the FSPCA Preventive Controls for Human Food Course.

o Comprehensive workbook & manual with the presentation slides & resources o Fillable forms & sample food safety plans o Official FSPCA Certificate issued by AFDO (Association of Food and Drug Officials) o Networking opportunities o Coffee breaks o Lunch

Lead Instructor Jacek Sztabowski, ProFOOD Consulting LLC. Charlotte, North Carolina, USA Jacek is the Managing Director of ProFood Consulting and has over a decade of experience in food safety, quality assurance, training and auditing. Jacek has consulted in all food industry segments specializing in food safety and HACCP. He has monitored compliance with all regulatory and GFSI standards and

acted as a technical expert for food and food packaging sectors. He has instructed numerous short-courses and workshops across the world on HACCP, FSMA, Quality Systems and Food Safety. Jacek is a HACCP Alliance Certified Trainer for HACCP and a Lead Instructor for Preventive Controls for Human Foods to teach FDA Recognized Curriculum for PCQI. Jacek’s experiences have enabled him to obtain an extensive list of professional auditor registrations including SQF, BRC, FSSC 22000, ISO 220000, and IBWA. Jacek’s involvement, expertise and passion for the food safety enables him to be a consistent, effective auditor for suppliers while providing a true demonstration of the respective auditing and certification scheme. Jacek holds a Bachelor’s degree in Food Science and a Master’s degree in Food Technology and Engineering from Wroclaw University of Environmental and Life Science in Poland.

http://www.profoodconsulting.com/



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ProFOOD Consulting LLC. Training courses – Terms and conditions

1) Policies on Payment a. Upon registration, if the course has been confirmed with sufficient attendance under

ProFOOD’s policy, a full payment of the course fee is required. Course registration is not official until required payment is received by ProFOOD.

b. ProFOOD accepts Visa, MasterCard, Discover, and American Express credit cards. If another method of payment is required, please contact us at [email protected]

2) Course Confirmation a. Course Confirmation Notice will be sent to the delegate’s provided e-mail address prior

to the start of the training course once the training course is confirmed with sufficient attendance.

b. All delegates are highly recommended NOT to make any travel arrangement (if applicable) until our Course Confirmation Notice has been received via e-mail. ProFOOD shall not be held liable in the event that the delegates incur any expenses due to making travel arrangements, etc.

3) Policies on Transfers, Withdrawals, Cancellations a. Delegate may transfer his/her seat to another person without any additional fees. In this

case, the delegate shall notify ProFOOD by e-mail at least seven (7) calendar days prior to the start of the scheduled course. If no notice is received from the delegate prior to the start of the scheduled course, the delegate’s request for seat transfer may be declined.

b. If the delegate decides to withdraw from a course, there will be a refund (if paid) minus 10% administration fee of the posted course fee on our training website when a written notice of withdrawal is received by our office at least twenty one (21) calendar days prior to the start of the scheduled course.

c. There will be NO refund in any cases if the written notice of withdrawal is received by our office less than twenty one (21) calendar days before the start date of the scheduled course or if the delegate does not attend the training course at all with no exception.

d. If the delegate registers for our training course less than twenty one(21) calendar days from the start date of the course and decides to withdraw from the registered course, full payment of the required course fee shall be made and no refund of any paid amount shall be allowed in any circumstances.

e. ProFOOD reserves the right to cancel any training courses at any time due to unforeseen circumstances. ProFOOD shall not be liable whatsoever in respect to the consequence of such cancellation. In the event that ProFOOD decides to cancel the training course, the registered delegate will be automatically transferred to our next available course of similar nature. If requested by the delegate, the delegate may also be entitled to receive a refund (if paid) or have the paid fee credited toward another training course.


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