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----- IRCA certified ISO 22000 FSMS lead auditor course, based on FSSC 22000
By Harold Metsoja 24 Mar 2014 - IFSQN.

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Event Organizer Integra Training & Consultancy
Contact Name Harold Metsoja
Contact Number 44(0)1722 338138
Contact Email harold@integra-training-consultancy.co.uk
Event Category Training Course
Event State/City Royal Wooton Bassett, Swindon
Event Country United Kingdom
Cost of Attendance £1450 (residential) / £975 (non-residential)
Event/Registration URL

Event Description


The training is an ISO 22000 auditor / lead auditor course, incorporating ISO 22002-1, required for FSSC 22000 audits. The standard is gaining rapid momentum in the food, drinks, packaging and feed industries and the intention is for it to apply to all food chain sectors. By concentrating on FSSC 22000 attendees gain a more up to date & comprehensive understanding of food safety systems.

This 5 day course is certified by the IRCA (no. A17687). The programme and learning objectives are attached.

In the UK courses are planned for:
  • 24 – 28 March 2014 in Royal Wooton Basset, Swindon.
  • 19 - 23 May 2014 in Welwyn Garden City.
Attendance will ensure:
  • A complete understanding of ISO 22000:2005 AND the requirements of ISO/TS 22002-1.
  • You understand the certification requirements of FSSC 22000, a GFSI approved food safety certification scheme.
  • You gain the knowledge and skills to undertake value added internal, supplier and 3rd party food safety audits.
  • You are able to audit hazard analysis processes, PRP’s, and HACCP control systems.
  • You are able to prepare, conduct, report and follow-up FSMS audits in accordance with ISO 19011, Guidance to auditing Management Systems.
The cost will be £1450 for four nights’ accommodation and all meals from the Monday morning. Non-residential attendance (all course refreshments and lunches) will cost £975. Bed & breakfast for the Sunday night, if needed, is an extra at £65. Vat tax may be applicable.

​For non-UK participants collection from / return to a convenient airport can be arranged at no extra cost.

Two weeks before the course we will send out comprehensive joining instructions which will include pre-course reading / exercises.

To successfully complete the course participants need to pass the end of course exam and the individual continuous assessment.

Course pre-requisites

For course participants these are:
  • Experience of working in the food chain.
  • Working knowledge to PRP’s, HACCP and GMP.
  • Knowledge of the laws that apply to their experience in the food chain.
You can make a booking by telephone, email or via our website.

Please contact me at any time if you require more information.

Regards

Harold Metsoja
Principal Trainer & Consultant

Integra Training & Consultancy
PO Box 1541, Salisbury, SP1 1SN, United Kingdom

T: +44(0)1722 338138
E: harold@integra-training-consultancy.co.uk
W: www.integra-training-consultancy.com·

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----- CAPA, Failure Investigation and Root Cause Analysis - FDA Expectations
By COCOM 25 Mar 2014 - IFSQN.

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Logo URL
Event Organizer ComplianceOnline
Contact Name Referral
Contact Number +1-650-620-3915
Contact Email referral@complianceonline.com
Event Category Conference
Event State/City California
Event Country USA
Cost of Attendance $299.00
Event/Registration URL http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702012?channel=IFSQN

Event Description


This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.

Why Should You Attend:

The most important area audited by the FDA is CAPA - it assures the FDA that company is in compliance without the Agency constantly auditing it.
Closed-loop CAPA mandates a repeatable, systematic Failure Investigation and Root Cause Analysis - define, locate and resolve the basic problem(s) or root cause(s). A full-capture investigation, verification/validation, monitoring, change control methodology, coupled with accurate root cause analysis is crucial to a "closed-loop" CAPA system, that meets / exceeds CGMP requirements and U.S. FDA expectations.

This webinar will present simple but powerful tools, the systematic and regular use of which, can resolve the key underlying problem and close out CAPA documents in a timely manner. The information and tools presented in this webinar can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.

Areas Covered in the Webinar:
  • U.S. FDA's CAPA Expectations
  • What is "closed loop" CAPA?
  • Correction, Corrective Action, Preventive Action
  • Failure Investigation using an FI Template
  • 7 Powerful Tools for Root Cause Analysis
  • Investigation Detail - Root or Probable Cause
  • Impact -- Often neglected but of major importance
  • Effectiveness -- Determining and Monitoring
  • Institutionalize vs. Entropy
Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need a repeatable methodology / defined systems, and simple but powerful tools for "closed loop" CAPA, including proper failure investigation / root cause analysis and making the fix permanent. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • R&D and Engineering
  • All personnel tasked with problem solving
Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company. He has over 32 years experience in U.S. FDA-regulated industries, 18 years of which have been as a full time, practicing consultant. John has worked with companies from start-up o Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, and conducted workshops and webinars worldwide. He is a graduate of UCLA.


----- Understanding FDA Import Alerts: What Are They and Recommendations for Removing Your Company and Products from an Alert
By COCOM 25 Mar 2014 - IFSQN.

Permalink
Logo URL
Event Organizer ComplianceOnline
Contact Name Referral
Contact Number +1-650-620-3915
Contact Email referral@complianceonline.com
Event Category Conference
Event State/City California
Event Country USA
Cost of Attendance $249.00
Event/Registration URL http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703313?channel=IFSQN

Event Description


This webinar will focus on the different types of import alerts issued by the FDA. It will provide the attendees strategic recommendations for removing one’s company and/or products from an import alert.

Why Should You Attend:

An import alert allows the FDA to detain, without physical examination, products that either have or potentially could violate the Food, Drug, and Cosmetic Act (“FDC Act”). Import alerts lets FDA field staff knows that the agency has enough evidence or other information to refuse admission of future shipments of an imported article. There are a variety of factors that could lead the FDA to place a product, manufacturer, shipper, grower, geographical area, and/or country on import alert.
This webinar will provide attendees with background about FDA import alerts, examine why there are issues, where to locate them, how to find out whether a company or product is the subject of an import alert, and finally, provide a series of strategic recommendations for removing a company or product from an alert.

Learning objectives:
  • Understand the nature of import alerts: What are they? What purpose do they serve? What do they mean for a company?
  • Become familiar with CBP and FDA’s shared jurisdiction at U.S. ports.
  • Understand company or products to be added to an import alert.
  • Be able to find and search FDA’s database of import alerts.
  • Understand the potential and real impact of being named on an FDA import alert.
  • Be able to identify the steps for removing a company or product from an import alert.
  • Know what to do if you learn that your products are being detained by FDA at a port and your company’s name is added to an import alert.
Areas Covered in the Webinar:
  • Import alerts
  • The different types of import alert issued by FDA
  • What causes a country, company or products to be added to an import alert
  • What impact does being named on an import alert have on a company
  • What to do if your products are held or detained at the port by FDA
  • What to do if your company or products are named on an import alert
  • Strategic recommendations for removing one’s company and/or products from an import alert
Who Will Benefit:
This webinar will be beneficial for the individuals in pharmaceutical, biologics, animal health, food, medical device and other biotech companies. Following personnel will benefit:
  • Regulatory Affairs
  • Managers
  • Consultants
  • Scientists
  • Research Analysts
  • State Policy Officials
  • Insurers focusing on Representations & Warranties Insurance
  • Investment Analysts
  • Venture Capitalists
  • Labelers
  • Product Distributors
  • Importers, Customs Brokers
  • Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries
Instructor Profile:
Karl Nobert, is a Food and Drug Regulatory Attorney in Washington, DC. Mr. Nobert regularly provides FDA regulatory advice and counseling to domestic and international pharmaceutical, medical device, OTC drug, medical devices and veterinary drug companies. He advises his clients on issues related to the FDA’s regulation of their products and provides them with strategic recommendations for regulatory compliance and mitigating potential enforcement risk. He frequently presents and has published on such topics.


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