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.

Article on FDA 21 CFR Part 11 Compliance

FDA-regulated industries electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these.

The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order to deem electronic signatures authentic. The electronic records, electronic signatures, and handwritten signatures executed to electronic records of several FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries have to be compliant with the standards set out in FDA 21 CFR Part 11 Compliance to prove that these are authentic, safe and trustworthy. The operative factor is that the FDA has to consider these signatures as being on par with those done on paper.

Which industries are included in FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 Compliance applies to nearly all FDA-regulated industries, including but not restricted to:

  • Medical device manufacturers
  • Drug makers
  • CROs
  • Biotech companies, and
  • Biologics developers

The Aim of FDA 21 CFR Part 11 Compliance

The aim of FDA 21 CFR Part 11 Compliance is to ensure that specified FDA-regulated industries such as those mentioned above (with specific exceptions) implement controls -which could include audits, audit trails, documentation, system validations, and electronic signatures -for software and systems involved in processing electronic data that are:

  • Required to be maintained by the FDA predicate rules or
  • Used to demonstrate compliance to a predicate rule. The FDA describes a predicate rule as any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. FDA 21 CFR Part 11 Compliance also applies to submissions made to the FDA in electronic format, such as a new drug application.

Which industries are exempt from FDA 21 CFR Part 11 Compliance?

Interestingly, exceptions are allowed within the same industry, based on the format of filing. For example, while FDA 21 CFR Part 11 Compliance applies to submissions made to the FDA in electronic format; it does not apply to a paper submission for the same made in electronic format, such as fax.

Also, FDA 21 CFR Part 11 compliance is not required for record retention for trace backs by food manufacturers. Similar to the logic used in the mode of filing as noted above; most food manufacturers are not otherwise explicitly required to keep detailed records, but when organizations keep electronic documentation for HACCP and similar requirements; this documentation must meet these requirements.

Learn more on this topic by visiting : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900774SEMINAR?linkedin-SEO

Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket submissions that win regulatory approval challenging? It is the fact, acknowledged by the FDA itself, that the PMA is the most stringent type of device marketing application required by the FDA. The PMA should be secured from the FDA before the company markets the medical device. The FDA gives its approval of the PMA for a Class II medical device only after it determines that all the elements necessary for assuring that the application has enough scientific confirmation that it is safe and effective for the intended uses it is going to be put to. Preparing premarket submissions thus is an onerous task by any stretch of imagination.

Another element of preparing premarket submissions that win regulatory approval

Another aspect of preparing premarket submissions is the 510 (k). The 510 (k) is essentially a kind of premarket submission that is made to the FDA to show that the device that a manufacturer intends to market is at least as effective and safe as a legally marketed device of its equivalence, already in the market, that is not subject to PMA. The FDA calls this principle the substantial equivalency (SE) and the device that is used as the reference for equivalence, the predicate device. The requirements governing SE are contained in 21 CFR 807.92(a) (3).

On top of all these, regulatory professionals have the responsibility of creating preparing premarket submissions that should not only convincingly demonstrate the ways of stating and explaining regulatory arguments for their device to the U.S. FDA reviewer for getting the approval; they should also be presentable and well-organized, without being cluttered or confusing.

Professional trainings for preparing premarket submissions that win regulatory approval

Given all these, it goes without saying that a completely thorough understanding and knowledge of the relevant U.S. FDA laws, regulations and requirements is absolutely necessary for regulatory professionals. This in-depth understanding can be had only from thorough training, which is indispensable if the medical device company is to win a clearance or approval.

The ways by which to do this is the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will impart. The Director of this seminar is Subhash Patel, a very senior regulatory professional and founder of New Jersey-based MD Reg Consulting LLC, which serves medical device industry clients in all aspects of global regulatory affairs specific to their needs.

To enroll for this highly valuable training session on how to successfully prepare 510(k)/Pre-IDE/IDE and PMA premarket submissions that secure clearances and approvals from the FDA, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900776SEMINAR?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.

The grasp needed for preparing premarket submission that win regulatory approval

At this seminar, Patel will demonstrate the grasp that regulatory professionals in the medical devices industry need for working with the FDA officials during the review and approval process of their submission. He will offer a complete understanding of the major aspects of FDA premarket submissions.

While knowledge of the regulatory process is one thing; medical device companies also need to know how to set and state regulatory arguments for their device in a most convincing manner to the FDA reviewer. This knowledge will be part of this course. In the process of explaining how to prepare premarket submissions that win regulatory approval; Patel will also offer tips and suggestions to participants on how to work effectively with the U.S. FDA officials during review and approval process of their submission.

During the course of these two days, Patel will cover the following core elements of how to prepare premarket submissions. He will explain the following:

o  History and background of U.S FDA Laws and Regulations

o  Classify Your Device

o  Choose the Correct Premarket Submission for your device

o  Compile the Appropriate Information for your Premarket Submission

o  Author and Prepare your Premarket Submission

o  Submit your Premarket Submission to the FDA

o  Interact with FDA Staff during Review and Approval

o  Complete the Establishment Registration and Device Listing

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

The impact of effective complaint handling on quality system

Effective complaint handling makes an extremely important impact on the quality system. An effective complaint handling is at the core of a quality system. If a product enters the market having got FDA approval and still receives complaints, it means that the device needs to be worked on and the complaint redressed. Effective complaint handling on quality system is meaningful when complaints are thoroughly analyzed and investigated.

Helps in correcting flaws

Complaints serve as a great means for making manufacturers of medical devices understand the problem at its root. It is this understanding that will help them to come up with solutions to these problems. Having an effective complaint handling on quality system in place is an FDA requirement from a medical device manufacturer. Complaints are the platform from which to evaluate, investigate and analyze the device and later take corrective action.

The MDR

To facilitate effective complaint handling on quality system; the FDA has a mechanism. Called the Medical Device Reporting (MDR); this system is meant for receiving medical device adverse events from manufacturers, importers and user facilities. This mechanism helps in quick detection and correction of adverse events. User Facilities (e.g., hospitals, nursing homes) need to report suspected medical device related deaths to both the FDA and the manufacturers.

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