Standard Operating Procedures are crucial documents in the regulatory industry

 

Standard Operating Procedures (SOPs) are very important documents that can make or break an organization in the regulatory industry. In simple terms, a Standard Operating Procedure, as suggested in its nomenclature, is a description of a specific operational procedure in which all the activities necessary to complete tasks that conform to established best practices, set regulatory requirements for the particular industry, and the relevant State or local laws provincial laws are explained. Many a time, a Standard Operating Procedure can be just a description of the organization’s own mode of doing things related to its business.

So, this description leads to the fact that since a Standard Operating Procedure is a detailed description of how things are to be done by an organization; any such document in the medical devices industry contains a list of step-by-step procedures the manufacturing organization lays down for producing its products. In a larger sense, an SOP is a complete depiction of all the practices followed by a business that has to meet the required quality and regulatory standards.

Get trained on how to write Standard Operating Procedures effectively

Given the acute importance of Standard Operating Procedures; it is important for regulatory professionals to get a clear idea of how to approach them by getting a thorough understanding of this concept. A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is being organized to give a thorough understanding of how to write Standard Operating Procedures effectively for the medical devices industry.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, who has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and who manages activities within the global regulatory and compliance space; will be the Director of this seminar.  To gain a clear understanding of the topic of Standard Operating Procedures for the medical devices industry, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900760SEMINAR?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.

A clear clarification of all the major issues and aspects relating to Standard Operating Procedures will be one of the core purposes of this seminar. Writing a Standard Operating Procedure should be simple, or at least, that is what it appears in theory. In reality though, writing Standard Operating Procedures or procedural documents is quite challenging in the regulated industries, because the Standard Operating Procedures have to take a whole host of procedures, processes, practices and factors into consideration.

The FDA requires “proof of establish” for writing Standard Operating Procedures

In order to make this easier, the Director of this seminar will make the participants of this seminar understand the cornerstone of writing Standard Operating Procedures, which for the medical devices industry, is what the FDA calls “proof of establish”. This is the foundation of FDA regulations and guidance documents for this industry, and consists of the entire array of activities pertaining to the practice of how to define, document (in writing or electronically) and implement that which is written.

Once this rationale for the Standard Operating Procedures is clear, the step-by-step set of instructions needed for performing a particular job or task in the regulated industries flows more easily.  This is the teaching David will instill at this seminar on Standard Operating Procedures.

Writing Standard Operating Procedures is not the end; implementing what is written is

This said, writing the set of Standard Operating Procedures is by no means the end of the work for regulatory professionals. Implementing that which has been created and are in the process of being created is much more vital. David will offer understanding of this aspect by presenting topics associated with how to write, format, execute, manage and globally harmonize Standard Operating Procedures. This is going to be explained keeping in mind the fact that SOP’s are the most popular documents audited by FDA and other Agencies, as well as by auditors and customers.

Standard Operating Procedures and GDP

This seminar on Standard Operating Procedures will also give a detailed understanding of Good Documentation Practices required by companies to ensure GMP compliance and the role played by Standard Operating Procedures in helping achieve the required level of compliance and quality.

This seminar will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The Director will show recent enforcement actions for Standard Operating Procedures related violations, most of which are documentation related. He will also emphasize the fact that Standard Operating Procedures work best when they are designed to achieve specific results, and will teach participants the ways by which to determine what business goals will be achieved through better management with Standard Operating Procedures and how those goals will be measured.

https://www.brampton.ca/EN/Business/BEC/resources/Documents/What%20is%20a%20Standard%20Operating%20Procedure(SOP).pdf

Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of defective devices and can be an important inoculation against stringent FDA actions.

Medical device reporting and recalls are a major FDA activity. Medical device companies have clear instructions on how to initiate medical device reporting (MDR) and recalls.

What is medical device reporting?

Procedures for medical device reporting are governed by 21 CFR 803, which has details regarding how a medical device company should go about its MDR.

Who have to make MDR?

The FDA deems it mandatory for these entities to report certain types of adverse events and product problems:

For the following entities, MDR is voluntary and is to be done when serious adverse events are detected in the medical devices they use:

  • Professionals
  • Patients
  • Caregivers, and
  • Consumers

These categories can also report issues relating to product quality, therapeutic errors and use errors.

What is a recall?

A recall can be either of these:

  • When a firm voluntarily removes or corrects an already marketed device that is found by the FDA to be in violation of its governing act on these devices, namely the Federal Food, Drug, and Cosmetic Act. Seizure of a medical device is an example of this kind of action.
  • A recall also happens when a firm voluntarily determines, after investigation, that a device is adulterated in some way. An example of this instance is misbranding, when a manufacturer discovers that the device is not fulfilling its intended use.

A recall is important for two reasons:

How does a medical device company report a recall?

Firms have to follow 21 CFR Part 806 when they have to reporting Medical Devices Recalls, as set out by The Center for Devices and Radiological Health. The Center makes it a requirement for a firm to report when the medical device is posing a risk to health. This has to be reported to the FDA District Office in which the firm is located.

Our webinars can help you gain more comprehensive knowledge of this topic and related ones. Click here (link) for details.

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A complete understanding of the payroll law

Those who are responsible for payroll or employer tax withholding compliance or have just been hired or promoted into the payroll department would have discovered during their indoctrination just how important this role is to the success of the organization.

Their learning is a continuous process that goes on and on. Employees in this position need to build a solid foundation for handling their company’s payroll obligations and complying with federal and state payroll laws. They need to be familiar with how to find the authoritative laws to support their policies and procedures.

Clear and comprehensive learning

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will help participants achieve this. Miles Hutchinson, who is President, Sales Tax Advisors, Inc., and is a CGMA and experienced businessman, who brings over 35 years in the field, will be the Director of this seminar. To gain the benefit of learning from this expert, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900485SEMINAR.

Equipping participants with the law in all its depth

This organized and thoughtful learning session will help participants accelerate their learning and understand how to handle their role with confidence. Miles will help participants who are concerned about their company’s ability to comply with U.S. labor and payroll laws with a formal study of the rules of engagement. This will help ensure that their company pays their employees fairly and handles tax and other withholdings appropriately, as mandated by law.

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Miles will show where to find the laws, how to interpret them and how to apply them in the most effective ways. The objective of this learning is to equip its participants with the skill and knowledge needed to master the laws and identify the best practices to keep their organization in compliance and out of court. Implementing this saves them huge sums of money in fines and legal.

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A very broad range of topics will be covered at this seminar. These include:

  • Worker classification
  • Employee classification
  • Ways of establishing methods and rates of pay
  • What must be included in the rate of pay
  • Hours that must be compensated as worked time
  • Required benefits
  • De minimus working fringes
  • Withholdings and deductions from pay
  • Voluntary deductions
  • Child support and garnishment orders
  • Payroll reporting
  • Analysis of risks of noncompliance
  • Proper documentation of the policies and procedures and record retention requirements.

Globalcompliancepanel Successfully Completed Seminar in Los Angeles -New FDA FSMA Rules

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

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Globalcompliancepanel Successfully Completed Seminar in Philadelphia-Design of Experiments and Statistical Process

Design of Experiments and Statistical Process Control for Process Development and Validation

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