New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and adherence to them

The U.S. Food and Drug Administration (FDA) is in the process of finalising food safety rules. A major part of these rules is devoted to the ways by which to ensure scientific and safe transportation and logistics food transportation. The FDA is required to establish rules for that improve, audit and enforce new rules relating to food transportation. This is something required by the Food Safety Modernization Act (FSMA), under congressional instructions.

Many aspects of food transportation come under the ambit of these new FSMA Rules. These include:

–       Foods not completely enclosed by a container

–       Prevention and reduction in adulteration and risk

–       Personnel training and certification for this purpose

–       Inspecting food and collecting data

–       Maintaining compliance and reporting about its evidence.

How to do this right?

Comprehension of all the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods is necessary and important for organizations that work in food transportation. They also need to know how to implement these rules. It is this understanding that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer at a seminar it is organizing.

The Director of this two-day seminar is John Ryan, President, TransCert, QualityInFoodSafety, RyanSystems. To gain insights into how to understand all the aspects of the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and to understand how to comply with them, just register for this session by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900810?wordpress-SEO . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion

At this seminar, the Director will arm participants with an understanding of the legal requirements of food transportation and how to develop a company plan that meets the expectations and requirements of both its customers and the FDA. Also offered is total understanding and review of the ways of establishing the right temperature monitoring, sanitation, container test and traceability, training and data reporting procedures.

Technological aspects of FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

Technological aspects of food transportation are gaining importance. These include new low cost GPS enabled traceability and temperature monitoring technology, EPA approved container sanitizers, washout technologies, temperature maintenance equipment, and food residue and bio-contaminant testing. FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods have a close relationship with these. The Director of this seminar will take these up for examination.

In reviewing the future of transportation food safety in the light of new and evolving technologies; the Director will dot the seminar with references to upcoming technology providers and provide Internet links to detailed information on the same.

This seminar is immensely useful for food supply chain logistics and food safety and security personnel whose primary responsibilities include management, sanitation, quality and operations. Those involved with handling incoming and outgoing food shipments, maintaining transportation equipment and tools, and purchasing or selling will also derive high value out of this seminar.

Think like the FDA to get compliance right

If an organization in an FDA-regulated industry has to show compliance with its systems; the most effective way for it is to think the way the FDA does. This is the right approach to getting its compliance requirements right.

FDA inspections can result in anything going all the way up to Warning Letters, seizures, injunctions, prosecutions, or recalls or consent decrees if serious violations are discovered at inspections. How does one inculcate the FDA line of thinking on compliance? Organizations need to first get an understanding of what the FDA looks for and keep these in compliance.

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The core of all compliance activity is possession and demonstration of control over the company’s Quality System. When an organization shows this using the subsystem approach; it gives the FDA fewer opportunities to cite minor deviations from the quality system regulation. This is the basis to avoid being cited for more serious systemic deviations from the regulation.

Gaining understanding through training

Proper training on these aspects goes a long way in helping organizations steer clear of issues that give an opportunity for the FDA to take these actions. A two-day seminar from GlobalCompliancePanel, a well-known provider of professional trainings in the regulatory compliance area, will be of immense value in helping professionals get a clear idea of how to get their compliance requirements right.

Just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900523 to learn about the ways of getting into the FDA’s line of thinking on compliance. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The Director of this seminar, David Dills, Global Regulatory Affairs & Compliance Consultant, who has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services, will offer a clear understanding of all the critical components of dealing with an FDA inspection, such as:

FDA History, Inspectional Strategy and Techniques

  • SOPs
  • Training
  • Audits
  • Managing the Inspection and State of Readiness
  • Responding to FDA Inspectional Observations (483s)/Warning Letters
  • Mock Inspections
  • Compliance Program 7356.002, Drug Manufacturing Inspections and other Compliance Programs Device Manufacturing Inspections
  • IOM (Investigations Operations Manual)
  • RPM (Regulatory Procedures Manual)
  • Field Management Directives
  • Inspection Technical Guides and official documents used as reference material for investigators and other FDA personnel

Warning Letter and Notice of Violation Responses/Communicating with FDA

  • Strategy and Remediation Implementation
  • Drafting
  • Liaison with FDA to ensure Close-out
  • Effective Responses

State of Readiness/Practice/Mock Inspections

  • Prepare for “real” inspections by being ready and not caught off guard
  • Practice Sessions and Dress Rehearsals on Day Two

 

Medical device regulatory compliance training

For any professional in the medical devices industry; training is a must. This training has to be on the regulatory aspects of the industry profession, because this is at the root of the profession. Medical devices being one of the most regulated industries, a professional in this industry is governed by a slew of regulations.

Medical device regulatory compliance training is thus necessary to help them achieve two ideals: one, to enter the profession, and two, once they are part of the profession, to keep updating their skills and knowledge, since this an ever-changing field. New technologies and other developments warrant new regulations. So, medical device regulatory compliance training is essential for anyone in the profession to both start and to advance in it.

Who carries out medical device regulatory compliance training?

The FDA authorizes a few select certifying bodies to carry out medical device regulatory compliance training. It sets out the nature, as well as the other technicalities such as syllabus, duration of course, rewards system and so on. The authorized certifying body then runs the course that addresses the requirements of medical device professionals. Many of these certifying bodies carry out these designated, authorized trainings in a number of formats, which professionals can choose from based on their convenience and need.

What do these courses contain?

Being authorized courses, the medical device regulatory compliance training courses from authorized certifying bodies cover nearly all areas of compliance training for medical devices. There are a few core subjects as well as a few optional ones. Generally, although not necessarily, most courses consist of these training syllabi:

  • Overview of FDA Regulatory Compliance for Medical Devices
  • Design Control
  • Design Validation, Verification, and Risk Analysis
  • Medical Device Submissions – 510ks, PMAs, and Exemptions
  • Process Validation

In addition, professionals enrolling for medical device regulatory compliance training can choose from a range of electives. Typically, they are offered the option of choosing one among:

  • FDA Inspections
  • Post Market Surveillance and Complaint Handling Systems
  • EU Directives, Guidance, CE Marking and ISO Standards Certifications
  • Recalls, Product Recovery and Safety Alerts
  • Risk Management
  • European Regulatory Procedures
  • Auditing and Qualifying Suppliers and Vendors
  • Computer Systems Validation
  • Document Management
  • Quality Assurance Auditing for FDA Regulated Industries
  • Writing Standard Operating Procedures and Other Documents
  • The EU Clinical Trial Directive
  • Technical Writing for the relevant industries
  • Root Cause Analysis of Failures & Deviations – Developing CAPA Strategy

References:

http://www.cfpa.com/about-us/

http://www.cfpie.com/content.aspx?c=CMDCP

 

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

Calibration and qualification in analytical laboratories

Calibration and qualification in analytical laboratories is needed because laboratory equipment should demonstrate suitability for the intended use. The way to do this is by calibrating and qualifying them. Calibration and qualification in analytical laboratories are also necessary because they are subject to FDA inspections.

Laboratory equipment is high risk systems

Calibration and qualification in analytical laboratories are necessary also because laboratory equipment is high risk systems in that they impact product quality greatly. Because of this categorization, equipment calibration and qualification is a frequently cited deviation in FDA inspectional observations. They are also targets of warning letters. To avoid all these scenarios, calibration and qualification in analytical laboratories is called for, although it is possible that many times, companies are not sure on exactly which of their equipment they need to calibrate, qualify, test and document.

Important factors

Three important factors impact the reliability of analytical data generated from chemical and physical analyses critically:

  • How much validity the analytical methods used have;
  • The extent to which the instruments used for the experiments are reliable;
  • How well and how appropriately the analysts undertaking the calibration and training are trained

What does the FDA say?

The FDA’s c-GMP requirements (CFR – Code of Federal Regulations, Subpart I: Laboratory Controls, S211.160 (b) (4)) has this to say about the scope of calibration and qualification in analytical laboratories:

“The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used.”

References:

http://www.cvg.ca/images/Qualification.pdf

http://www.labcompliance.com/seminars/audio/226/default.aspx

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539