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SERVICES
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GMPs AND HACCP TRAINING
QMRS provide professional training pertaining to GMPs, GDPs, and HACCP for Food & Drug industries
QMRS issue eight types of certificates that needed by regulatory authorities
HACCP training courses are accredited by the “International HACCP Alliance”
As per local and international regulatory authorities, the manufacturer should provide training in accordance with a written program for all operational personnel (including the technical, and maintenance personnel) to ensure that all persons are capable of carrying out all the necessary functions. Management should ensure that
1. Newly recruited personnel should receive training appropriate to the duties assigned to them. For example, in food industry, provision of training to individuals involved with the preparation, administration, monitoring, and verification of HACCP plans should be available
2. Ensure continuing training, and its practical effectiveness should be periodically assessed.
3. Training programs should be approved and training records should be kept.
4. Trainers and consultants should be qualified for the services they provide. Evidence of this should be included in the training records.
To fulfill these requirements, QMRS designed a number of training courses. In the following table please click on the course that interest you. The link will lead you to a PDF file, which contains more information on the course.
HACCP COURSES (BACKGROUND)
The objectives of HACCP courses are to provide delegates with a comprehensive coverage of the principles and application of HACCP system. Specifically, the courses provide the trainees with the necessary knowledge on HACCP Prerequisite Programs and on the determination of Critical Control Points in the HACCP system (including presentations and application exercises on monitoring system, Corrective actions, Verification procedures, and Documentation & record keeping).
As our training philosophy is “learning by doing is the basic principle underlying the acquisition of any skill”, participants will be asked to practice the actual skill they acquired. In fact, the training program designed to allocate about 60% of the training time for application exercises and the rest of the actual training time is given for the slides presentations.
Also, to ensure that the message get across, we have built the body of the training program to demonstrate the HACCP tasks step by step (in a logical development), and allocate adequate time for each task as per the training manual recommendation on “Food Hygiene and the Hazard Analysis and Critical Control Point System”, which issued by the Food and Agriculture Organization.
Furthermore, it could be worth mentioning that:
QMRS HACCP courses have been designed to meet the training requirements that established by FAO Codex Alimentarius Commission and the Canadian Food Inspection Agency (CFIA) guidelines.
QMRS HACCP courses and instructor have been assessed and accredited by “The International HACCP Alliance“ Organization.
The course is led by an internationally recognized expert in all aspects of food and drug regulatory affairs.
Your Presenter (Dr. Jalal Mokhalalati, Ph.D.)
Dr. Mokhalalati holds a B.Sc. in Agricultural Sciences from Egypt, M.Sc. degree in Animal Nutrition from University College of North Wales (UK), and a Ph.D. degree in the field of Human Nutrition from University of London (1981). Since then, he wrote a number of books and scientific papers, and he worked in various countries for different sectors, including university teaching.
In 2001, he retired from the last job with Abbott laboratories as a head of medical and regulatory affairs department in Saudi Arabia, and started his own consultation office in Canada to serve the Food and Drug industry in all aspects of HACCP training, site licensing (GMPs), Good Documentation Practices, and Health products registration with Health Canada.
TRAINING COURSES: TITLES, PRICES, AND LENGTH
COURSE TITLE
COST (CAD)
No. of
Days
Off-Site*
/Person
On-Site**
300.00
1500 .00
1
X
1500 .00
1
Dietary Supplements current GMPs Requirements (The USA Final Rule)
300.00
1500.00
1
300.00
1500 .00
1
X
2200.00
2
HACCP in Small and/or Less Developed Food Businesses
X
2200.00
2
300.00
2200.00
2
HACCP Principles, Development, and Implementation
X
3000.00
3
* This rate includes the cost of printed materials (the binder), mailing cost, and certification
** This rate does not include the travel expenses. The amount depends on the distance between the training site and the trainer location
x These training courses are not available offsite
Drug: Good Manufacturing Practices
COURSE OBJECTIVE
The objective is to provide the trainees with basic information on the current GMPs requirements to ensure that the finished products meet the requirements for product quality and purity..
LEARNING OUTCOME
After completing this course,
Participants will learn the principles of Quality Management System
Participants will learn the Good Manufacturing Practice elements (Personnel, Premises, Equipment, Materials, and products for product manufacturing.
Participants should become knowledgeable on the importance and the relationship of the establishment design drug hygiene.
And Should be able to establish adequate and appropriate personal, and sanitation programs
The trainees will learn the key aspects regarding process control system
The trainees will be knowledgeable on the documentation and records requirements including product complaint and recall systems.
The trainees will learn how to conduct Self-inspection and Quality Audits
WHO WILL BENEFIT
Regulatory and Quality assurance government personnel (inspectors).
Quality systems auditors
Plant operational (production) supervisors and managers
Middle-to-senior management
Newly hired plant technicians
Project managers for product development studies
COURSE LENGTH:
Two days
COURSE OBJECTIVE
The objective of this course is to provide the trainees with a comprehensive understanding of the Good Documentation Practices (GDPs) definition and requirements.
LEARNING OUTCOME
After completing this course, the participants should be knowledgeable on
How to develop and keep documents on his/her organization quality management system,
How to establish documents on product requirements (specifications),
How the facility document activities and processes (procedures),
And how one can establish objective evidence for activities performed or results achieved (records).
Participants will learn also the basic writing skills, and. step-by-step description of how to write SOPs and policy in an informative manner.
WHO WILL BENEFIT
Regulatory and quality assurance personnel
Quality systems auditors
Marketing personnel
Operational (production) managers
Middle-to-senior management
COURSE LENGTH:
One day
PRICE: CAD 350.00
Please click here to register or click Good Documentation Practices for more information
Dietary Supplements current GMPs Requirements (USA FDA Final Rule)
COURSE OBJECTIVE
The objective of this course is to provide the trainees with basic information on Good Manufacturing Practices elements to ensure the quality of the dietary supplement as described in FDA: 21 CFR Part 111 (final rule).
LEARNING OUTCOME
After completing this course, the participants should be knowledgeable on:
The GMPs and documentation minimum requirements.
The ingredients/product quality specifications (identity, strength, efficacy, purity, and safety)
Also, the USA new regulation will be compared with Health Canada Natural Health Products regulations
WHO WILL BENEFIT:
Regulatory/quality assurance personnel
Operational (production) managers
Quality systems auditors
Marketing personnel
Middle-to-senior management
COURSE LENGTH:
Two days
PRICE: CAD 350.00
Please click here to register or click Dietary Supplements current GMPs Requirements (The USA Final Rule) for more information
Natural Health Products: Good Manufacturing Practices (Health Canada)
COURSE OBJECTIVE
The objective of this course is to help the trainees to understand the Good Manufacturing Practice (GMP) requirements of the Health Canada Natural Health Products Regulations.
LEARNING OUTCOME
This course will provide valuable assistance to nutraceutical companies that seeking site license from Health Canada. After completing this course, the participants (Quality Assurance Persons) will be:
Equipped with the needed information to implement and maintain the GMP requirements
Quality Assurance Persons will learn how to fulfill their role in assuring the quality of a Natural Health Products before it is made available for sale.
Participants will learn also on how to complete the Quality Assurance Report and how to fulfill Health Canada needed documentation (SOPs and Records)
WHO WILL BENEFIT:
Quality assurance and regulatory personnel
Government inspectors
Operational (production) managers
Middle-to-senior management
COURSE LENGTH:
One day
GMPs Audit and the External Inspectors Practices
COURSE OBJECTIVE
The objective of this course is to define the requirements, responsibilities, and procedures for Quality Assurance (QA) Compliance Audits and to describe the usual governmental inspection practices
LEARNING OUTCOME
After completing this course, the participants should be able to:
Define the requirements, and procedures for GMPs and Quality Assurance (Internal Audit)
How to preparation for an inspection
Types of GMP inspection
Aware of the usual governmental inspector’s (or third party auditors) practices and role (The inspection).
Recommend specific methods and standards for responding to such inspectional activities
Ensure that periodic and planned audits of systems, training and documentation shall meet regulatory bodies and corporate requirements for current Good Manufacturing Practices,
WHO WILL BENEFIT
Quality assurance personnel/inspectors
Quality systems auditors
Drug, Dietary supplements and Natural Health Products operational managers
Middle-to-senior management
HACCP team members (coordinators)
COURSE LENGTH:
One day
PRICE: CAD 350.00
Please click here to register or click GMPs Audit and the External Inspectors Practices for more information
New HACCP IN SMALL AND/OR LESS-DEVELOPED FOOD BUSINESSES
LEARNING OUTCOME
It has been reported that food businesses are facing numerous constraints, with the result that HACCP implementation has been partial or ineffective. Therefore, systems have been developed with a more flexible approach and are usually referred to as "HACCP-based systems" or "systems based on the principles of HACCP". They are faithful to the seven principles of HACCP, but do not require the business to follow the traditional 12-step approach as outlined in the Codex guidelines.
THE COURSE OBJECTIVE
Is to review the current version of the Recommended International Code of HACCP System guidelines, which was revised by the Codex Alimentarius Commission in 2003 (CAC/RCP 1-1969, Rev. 4-2003), and to compare the new guideline with the Canadian (CFIA) and OMAFRA (Ontario Ministry of Agriculture, Food, and Rural Affairs) HACCP ADVANTAGE Guidelines.
Our aim is to provide the food processors and other interested parties with practical solutions for the implementation of HACCP in small and/or less-developed food businesses (SLDBs). The course will address the following topics:
1. Describe the HACCP-based system concept.
2. Challenges (Worldwide) facing small food business sector.
3. Define HACCP compliance barriers and identify causes
4. Assessment of HACCP compliance
5. Develop possible solutions
6. Overview of HACCP ADVANTAGE Prerequisite documentation requirements
7. The new approaches to facilitate HACCP application in SLDBs
8. Examples of new HACCP Forms
9. Example of a new (Easy) DECISION TREE to identify/determine the CCPs
10. Example of the new HACCP worksheet.
11. Establish the appropriate documentation pertaining to HACCP principles.
If you want to know more on the most recent version of the FAO Codex HACCP System and its amendments, we recommend registering for this novel course.
PRICE: CAD 750.00
Please click here to register or click HACCP in Small and/or Less Developed Food Businesses for more information
HACCP PREREQUISITE REQUIREMENTS
This course is accredited by the “International HACCP Alliance” Organization.
All trainees will be receiving a certificate of completion with the organization official seal
COURSE OBJECTIVES:
Our objectives are to provide the trainees with a comprehensive understanding of the HACCP Good Manufacturing Practices requirements.
LEARNING OUTCOME
Participants should become familiar with:
The Codex General Principles of Food Hygiene as a firm foundation for ensuring the development of effective HACCP and
The importance of identifying potential food safety hazards at the primary production stage of the food chain and the necessity of controlling or minimizing hazards at this stage (production stage).
Specifically, participants will learn about:
HACCP SYSTEM
HACCP background information
HACCP benefits and facts
The FAO Codex General Principles of Food Hygiene (Good Hygienic Practices
HACCP PREREQUISITES PROGRAMS (GMPs ELEMENTS)
Quality management system
Place
People
Processes
Products
Other food hygiene requirements (transportation and training)
IMPLEMENTING THE PREREQUISITES PROGRAMS (HACCP ADVANTAGE)
Control program
Training program
Operational controls
Environmental controls
AN INTRODUCTION TO HACCP PRINCIPLES AND TASKS
It is a prerequisite training course to participate in HACCP II training course (HACCP PRINCIPLES, DEVELOPMENT AND IMPLEMENTATION)
Other benefits:
Also, as per our clients’ requests and interests, we will allocate adequate time to discuss the principles of Good Documentation Practices.
Accordingly, we will address the following topics within HACCP I course:
Types of documents that used in GMPs and Quality Management System
The role of SOPs in GMPs compliance
Elements of SOP formats
Common problems and deficiencies with SOPs
Writing skills and documents development process and control
Furthermore, we will provide attendees with samples of SOPs and templates that required for GMPs certification and as an added bonus, all HACCP courses attendees will receive a free 40 pages policy, which contains information on: internal and suppliers audits, regulatory inspections practices, and Good Documentation Practices.
PRICE: CAD 700.00
Please click here to register or click HACCP Prerequisite Requirements for more information and to view the training course Agenda
HACCP PRINCIPLES, DEVELOPMENT, AND IMPLEMENTATION
This course is accredited by the “International HACCP Alliance” Organization.
All trainees will be receiving a certificate of completion with the organization official seal
COURSE OBJECTIVES
The objective of this course is to provide delegates with a comprehensive coverage of the principles and application of HACCP system. Specifically, the course provide the trainees with the necessary knowledge on HACCP principles & tasks and present guidance on the determination of Critical Control Points in the HACCP system and on establishing appropriate documentation and records of the HACCP system
LEARNING OUTCOME
After completing this course, the participants should be knowledgeable on HACCP development, and implementation as recommended by the CFIA and Codex Alimentarius Commission (FAO).
Specifically, participants will be provided with the necessary knowledge:
- On the appropriate composition and knowledge required for an effective HACCP team.
- To understand the importance and considerations of a complete product description and the identification of product ingredients and packaging materials.
- To construct an accurate and complete flow diagram and plant schematic and to its importance in understanding the specific processing operation
- To identify potential hazards associated with the flow of raw materials from the point at which they enter the plant, through processing to departure
- To consider the appropriate control measures for each potential hazard
- To determine critical control points in the HACCP system.
- To establish critical limits for the critical control points in the HACCP system.
- To establish a monitoring system for each critical control point in the HACCP plan.
- To establish effective procedures for corrective actions when there are deviations from critical limits at critical control points.
- To establish procedures for verifying control at each of the CCPs and for validating the adequacy of the overall HACCP plan.
- To establish appropriate documentation of the HACCP plan and records of the HACCP system.
WHO WILL BENEFIT?
This course is essential for:
All those interested in increasing their awareness in HACCP system development and implementation.
For those involved in ensuring that their food products meet the CFIA and the international legislative requirements.
It also benefits those seeking an update of current food safety laws.
PRICE: CAD 900.00
Please click here to register or click HACCP Principles, Development, and Implementation for more information and to view the training course Agenda
To register by fax or mail, please download the registration form
Please note that the registration fee includes the presentations materials, Continental breakfast, luncheon, refreshments, and course certification (attendees who completed the HACCP I or HACCP II courses, will have the International HACCP Alliance Seal on their certificates).
Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA)
HACCP PROGRAMS GOVERNMENT FUNDING
Financial assistance for food processors to adopt Good Manufacturing Practices (GMPs) and/or Hazard Analysis Critical Control Point (HACCP) is available through the Food Safety Initiative (FSI) program.
This program provides direct grants to non-federally registered food processors to offset the costs associated with developing, implementing and/or maintaining a GMPs or HACCP system. Grants are provided on a cost share basis; 90% is contributed by government.
The FSI program provides funding for the following costs associated with adopting GMPs or HACCP:
1. Consulting
2. Staff
3. Staff training
4. Equipment purchases required by the GMPs or HACCP to enhance food safety
5. Materials and supplies
6. Laboratory
7. Audit
The FSI program provides:
Up to $15,000 to eligible plants that choose to implement GMPs
Up to $20,000 to eligible plants that choose to implement GMPS and one HACCP plan
Up to $29,000 for additional HACCP plans up to a total of four HACCP plans
Application forms can be obtained by contacting the Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA) at 1-866-641-3663. Please click on the below link for more information
http://www.omafra.gov.on.ca/english/food/industry/food-safety-initiative.htm
PAYMENT OPTIONS
We offer an easy and secure payment via Pay Pal. You also have the option of paying by Cheque, or bank transfer in Canadian or US Dollar.
1. Pay with Credit Card via PayPal
This service is provided by PayPal, which provides a secure environment for the processing of on-line credit card transaction by using the most advanced privacy protection technology available.
The payment procedure (send money with PayPal) will depend on whether you have an account with PayPal or not
Please visit www.paypal.com to learn how you can send money
It is important to know that QMRS address and bank account is verified by PayPal.
2. Paying by Cheque
We accept certified or draft checks in Canadian, or US dollars. Please make cheque payable to ‘Quality Medical Regulations Services’ addressed to 196 Annapolis Circle, Ottawa, Ontario K1V 1Z1 Canada.
3. Paying by Bank Transfer
Payment could be sent to TD Canada Trust Bank Account number. Bank address will be provided to you upon your request. Please make sure that your bank’s wire fee is included in the amount transferred. Also, bank transfer could be done via the “Interac Email Money Transfer” procedure, if you have an account with any of the Canadian major banks)
Please note that Canadian clients should add a 5% to the total for the Goods and Services Taxes (Our GST No. is: 85555 2147 RT0001)
QMRS TRAINING POLICY
DISCOUNT POLICY:
Trainees will be eligible for a discount of:
1. A percentage of 10% of the indicated price if registration completed before four weeks of the course starting date
2. A percentage of 5%, if the trainee registered for more than one course. (Namely, if the person register for two courses, the discount will be 10% of the total prices of the two courses)
3. A percentage of 5% for each trainee who is belonging to a specific company or institution (Namely, if the institution is registering three persons, the discount will be 15% of the total prices of the three persons)
Please note that the maximum discount under any circumstances is 40% for any company or institution..
Example;
ABC company wish to send three employees for two courses and company management completed the registration forms four weeks before the courses starting dates.
Total discount is 35% of the standard prices, calculated as follow:
For early registration 10%
For the registration of two courses 10%
And for registering three employees 15%
CANCELLATION & REFUNDING POLICY:
Early cancellations:In case you need to cancel your registration, you should inform us two week or more prior to the course starting date. In that case, you will be refunded 75% of the registration fee.
Late cancellations:
If you cancel your registration less than two weeks prior to the training starting date, you will be refunded 50% of the registration fee.
If your fees have not been paid and you are cancelling the registration, you are still liable for the cancellation fees of 25 to 50% of the course(s) total price plus the GST.
Please note that if you register for the course and do not attend, you are liable for the full registration fee unless you cancel within the period stated above. However, you are entitled to attend the same course at different date with only 25% of the course regular price. Please note that delegate substitution will be accepted at any time
QMRS reserve the right to change the course date, and location without further notice and assumes no liability for these changes.
TRAINEE INFORMATION
when you decide to register for the trainings, you will be asked to provide us with certain information (such as your email address, phone number, etc.). Please note that the provided information is solely for the purpose of you attending the training or for the purpose of learning more about your satisfaction of our services and products. Anyhow, QMRS will not disclose to any third party any information you submit to us.System for reviewing the provided training
To verify and improve the quality of our services, we ask the course attendees to complete an evaluation form. Participant’s answers will be reviewed and analysed. Issues raised (such as the quality of teaching, resources, etc.) will be investigated and addressed.
Equality of Opportunity, Health, and Safety
To ensure the full satisfactions of all students, please let us know if you have any special requirements. For example, if you have a specific physical handicap or English is not your first language, please indicate so in the registration form. QMRS will exert the utmost efforts to satisfy all trainee’s needs
Complaints and Dissatisfaction
If you have any complaint or you are not satisfied with QMRS team member’s performance (or associated services, such as the training center employees), please do not hesitate to contact the principal (Dr. Jalal Mokhalalati as a sole person for dealing with such unusual issues, which could arise at any time. Dr. Jalal Mokhalalati contact details are shown elsewhere.Training Facilities
Our policy is to conduct the training in an approved, and well known training centers. Our key criterion is that; the facility should be easy to access, and allow people having a physical disability to access the premises in accordance with current Canadian legislation.ALL RIGHTS RESERVED
All rights are reserved by Quality Medical Regulations Services (QMRS).You agree not to reproduce, sell, translate, distribute, or commercially use in any manner (in part or in whole), the QMRS course materials