Objectivity and Professional Skepticism should be imbibed into organizational thinking

Professionals involved in almost any area of work need two extremely important traits for ensuring smooth conduct: Objectivity and Professional Skepticism. Although very important; they are difficult to enforce at all times and in all situations. It is exactly in challenging situations that these qualities are put to use like in no other. All important work and decisions taken should be based on objectivity and professional skepticism.

How does a professional learn how to cultivate objectivity and imbibe professional skepticism at work and the situations in which to use them to ensure that the organization mitigates several risks? This is what a webinar by Compliance4All, a respected provider of professional trainings in all areas of regulatory compliance, will be teaching. The details of this webinar can be had by visiting http://www.compliance4all.com/control/w_product/~product_id=500913LIVE

A means to choosing the right path and mitigating risks:

The most important benefit of learning to be objective and inculcating professional skepticism is that they are tools with which professionals learn to choose the right path when faced with difficult situations. The concepts relating to how to use the qualities of objectivity and professional skepticism at work will be taught at this webinar.

The expert at this webinar is Lynn Fountain, who has developed and delivered leading edge training sessions on COSO, internal audit, ERM, accounting, leadership, governance, compliance and ethics. 20 of the 35 years of her experience as a public and corporate accounting professional have been spent in internal and external auditing, making her a subject matter expert in multiple fields such as internal audit, ethics, fraud evaluations, Sarbanes-Oxley, enterprise risk management, governance, financial management and compliance.

Lynn will cover the following areas at this webinar:

o  Explore the requirements of professional skepticism

o  Explore the rules defining independent roles

o  Identify the difference between legality and ethics

o  Explore the top five techniques to execute independence

o  Explore the top five techniques to assist when employing objectivity

o  Recognize what to do when management challenges you


Getting their documentation right is very important for medical device manufacturers

Documentation is at the heart of medical devices. If a medical device manufacturer cannot convincingly establish documentation of the manufacturing process; the medical device is bound to have regulatory approval hurdles. Every medical device manufacturer has to both establish and maintain all of these: documents, procedures and records, all of which must be under a state of control.

So, what should the documentation establish and prove? Documentation should show that manufacturers followed the prescribed scientific methods and procedures while manufacturing the devices. Only records of all these processes are accepted as proof that all these were followed by the manufacturers. This means that manufacturers need to keep in place several records of varying types, which need to be corrected from time to time with every new step or a revision, and importantly, make these easily available to the designated/authorized personnel.

How do manufacturers get their documentation right?

Given the importance of documentation –the FDA can impose heavy penalties to medical device manufacturers who cannot show the authenticity and integrity of their documentation as well as the recordkeeping methods pertaining to it –it is necessary for manufacturers to be thorough with their methodology. This requires professional training, because this is not something that manufacturers can take chances with.

It is to equip medical device manufacturers with all the elements of documentation and recordkeeping of their medical devices that Compliance4All, a highly popular provider of professional trainings on all areas of regulatory compliance, will organize a webinar. This webinar will be imparted under the expert guidance of Susanne Manz, an accomplished leader in the medical device industry, who emphasizes quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. More details of this webinar can be had from http://www.compliance4all.com/control/w_product/~product_id=500918LIVE

Ways of ensuring documentation to meet regulatory requirements:

This webinar will be highly useful for personnel in the medical devices industry, for whom the proper method of documentation is critical. Susanne will show what procedures and methods personnel in the many tiers of the medical devices industry need to follow in order to be able to maintain records that are well documented to meet regulatory requirements and how to keep these in the right place for easy access and correction.

She will show how medical device manufacturers can present these records in a timely and neatly organized fashion to the regulatory authorities during inspections, along with ways by which the safety, integrity, authenticity and control of the documentation can be ensured, as well as how to make them accessible and correctable. In other words, this webinar is all about how to meet regulatory requirements pertaining to documentation, a basic requirement of the Quality Management Systems.

Susanne will cover the following topics at this webinar:

o  FDA expectations for Document Controls and Records Management

o  Lessons Learned from 483s and warning letters

o  Common problems and mistakes

o  Strategy for Document Control

o  How to structure your QMS and Document Management System

o  Methods and systems for controlling documents

o  Records retention

o  Best Practices

o  Preparing for an FDA Inspection

Good documentation lies at the heart of GxP environments

Good Documentation Practice (GDP) constitutes the backbone of any GxP environment. Not only is GDP a sound business practice; it is also an FDA requirement. This being the case, it is absolutely essential for FDA-regulated organizations to get their GDP right. An organization that does not get its GDP right risks facing a number of consequences.

Today’s regulatory requirements are stricter than ever before. In this environment of very rigid regulatory environment; individuals and companies have to comprehend and adhere to good documentation that meets FDA regulatory requirements.

A learning session to help get an idea of GDP:

In order to make those in regulatory professions understand the essence of GDP for GxP environments, Compliance4All, a highly reputable provider of professional trainings for the regulated industries, is organizing a very valuable webinar. Details of this webinar can be had from http://www.compliance4all.com/control/w_product/~product_id=500978LIVE.

The speaker at this webinar, John Godshalk, will make participants understand what needs to be documented, and the rationale for it, such as what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice (GDP) is, what needs to be documented, why it is documented, and FDA expectations for documentation.

Learning to understand the FDA’s requirements for GDP:

This learning session will explain what the GxP regulations and guidances say about Good Documentation Practice and offer examples of both good and poor documentation. It will offer exercises of both good and poor practices, which will help participants to come up with GDP that meets FDA requirements.

This session will give participants an idea of GDP for GxP environments. They will be able to understand what the FDA looks for in documentation, the relevant regulations that exist for documentation, and the related guidances.

John will cover the following areas at this webinar:

  • FDA 101: Who is the FDA, regulations, guidances, documentation and me
  • Why document?
  • What needs to be documented?
  • What documentation does FDA look for during an inspection?
  • What do the GMP, GCP, and GLP regulations and guidance’s say about documentation?
  • Examples and exercises for good documentation
  • Summary/Q&A

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Microbial monitoring becomes successful when myths about the topic are removed

Although unfortunate; it is true that those who work in water systems design them keeping obsolete concepts in mind. Why this happens is that the water systems organization is reluctant to be open-minded enough to update its water systems from time to time. The result is that the water systems get built on a shaky foundation, making them fundamentally weak.

Myths are the backbone of water systems failures

An additional problem faced by most microbial monitoring systems is the number of myths that have emerged from this field, which is mainly due to the major misunderstanding that professionals have regarding the topic of microbial monitoring.

Addressing these myths is the main purpose of a webinar that Compliance4All, a highly reputable provider of professional trainings in a number of areas including regulatory compliance, is organizing.

This webinar, for which water systems professionals in a number of positions can enroll by just logging on to http://www.compliance4all.com/control/w_product/~product_id=500969LIVE, will be from none other than the world renowned expert on pharmaceutical water systems, Teri C. Soli.

An in-depth look at the fallacies and misconceptions of water systems implementation

Dr. Soli will discuss the reasons for which such fallacies happen, but greater attention will be paid to how these systems can be corrected. He will drive home the point that if this has to happen, a few established myths have to be shattered.

This session seeks to quash popular myths surrounding water systems, the most important reason for which water systems go awry. Most of these myths relate to microbial control approaches and microbial monitoring. For microbial monitoring to be effective, myths resulting out of misconceptions need to be removed from many areas.

Putting the myths and facts in perspective

During this webinar, Dr. Soli will take up and demolish each myth surrounding water systems and will explain the scientific, not the “rule of thumb” approach, to each of these.

He will take up the following areas for discussion and set many misconceptions surrounding them right:

o   Why water myths develop:

·        Impact of c-GMPs

·        Well-meaning but misguided precedents

·        Scientifically unchallenged traditions and benchmarking

·        Rule-hungry culture

o   Water System Microbial Control Myths:

·        WFI from RO

·        Turbulent Flow and Flow Rate

·        Dead Leg Rules

·        Smooth Surfaces

·        In-Line Sterilizing Filters

·        Ozone

o   Microbial Enumeration Myths:

·        Referee Methods

·        Thermophiles in Hot Systems

·        R2A, 35°C, 5 days

·        Test Filter Membrane Rating

·        Compendial Action Levels

·        TOC and Endotoxin as Microbial Count Correlates

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A look at the principles of FDA requirements for medical devices

The FDA has some clear-cut requirements that those manufacturing medical devices have to meet in order to get their products approved. FDA requirements for medical devices cover regulations for these devices, based on the way they are classified, and for meeting set regulatory guidelines.

The FDA classifies medical devices according to the extent of their use and the potential they have for causing risk. FDA requirements for medical devices are based on this classification. This is how the FDA classifies medical devices:

Class I:These devices are considered least complicated in terms of their use, design and potential harm. This is why FDA requirements for medical devices are minimal, since their failure is likely to result in the least risk to the user. Examples of Class I medical devices are plasters and dressing kits. According to the FDA, 47 percent of all medical devices grouped into Class I.

Class II: FDA requirements for medical devices for Class II devices are based on the nature of these devices, which are considered slightly more complicated than Class I medical devices and have the potential to cause slightly higher injury in the case of failure. 43 percent of all FDA-approved devices fall in this category, whose examples could include test kits and wheelchairs.

Class III: Class III medical devices are those that are serious in the nature of their risk. These devices also carry the highest level of use for the user. Constituting barely a tenth of all medical devices; Class III medical devices could include life supporting systems such as pacemakers.

An important aspect of FDA requirements for medical devices is that a marketing application has to be submitted by the device’s makers if they have to get approval for marketing the device. FDA requirements for medical devices exempt many kinds of devices from this submission, but require their makers to be subject to the usual controls that are part of FDA requirements for medical devices.

General FDA requirements for medical devices

All medical devices from any manufacturer have to satisfy the following criteria to get approved:

Criteria for FDA requirements for medical devices:

The FDA has a few criteria that manufacturers of medical devices have to meet in order to have their medical devices approved:

1. 510 (K):


FDA requirements for medical devices include the 510 (K) submission, which is a submission that medical device manufacturers have to make to declare that their device is at least as safe as any other device in its category already in the market, or what is called Substantially Equivalent (SE).

2. Premarket approval:

The PMA is a request that a manufacturer makes to the FDA, by which it asks for clearance from the FDA to market a new Class III device or to continue to market an existing one in the same category.

3. Investigational Device Exemption:

An IDE is a mechanism by which the manufacturer of an investigational device is allowed permission to use effectiveness and safety data that can be used for making either a 510(K) submission or a PMA application to the FDA.

4. Good Manufacturing Practices:

FDA requirements for medical devices include GMP requirements to be met in all the areas of manufacture in accordance with the principles laid out in a Quality System (QS), such as designing, manufacturing, labelling, storing, installation and servicing of finished products.

A broad look at clinical research regulations

Clinical research regulations are directives that are aimed at making clinical research more effective and ethically justifiable. The tool or mechanism by which regulators ensure that clinical research regulations serve their purpose is what is called Good Clinical Practice (GCP).

Regulatory bodies around the world, irrespective of whether they function at national or global levels, formulate respective clinical research regulations that are aimed at ensuring that organizations involved in clinical research follow GCP guidelines. The idea is to bring about standardization and harmonization in the guidelines.

The broad aim of clinical research regulations, which has to ensure adherence to GCP guidelines, is to bring about quality and ethics into clinical research. Clinical research regulations consider any clinical research as being sufficient or effective only if it is conducted according to the principles of GCP and meets the criteria set out in GCP guidelines.


What are Good Clinical Practices?

Good Clinical Practices are a set of international quality standards formulated by the International Conference on Harmonization (ICH). The ICH is a global body that defines and sets forth guidelines for the clinical profession, which those in the industry and governments all around the world have to comply with. Many national clinical research regulations work alongside the guidelines issued by the ICH. Also, clinical research regulations usually work in tandem with similar guidelines for pharmaceuticals and medical devices.

ICH guidelines on clinical research regulations have regulations on all the major aspects of clinical research, such as:

Drawbacks of the clinical research regulations:

Some critics of the clinical research regulations have assailed it for its lack of punch in regulating a few areas of critical importance. Some of the criticisms levelled against clinical research regulations relate to the following:

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What are the functions of computer system validation process?

Computer system validation process is described as the documented procedure which assures that a computer system performs the exact functions it is intended to reproducibly, consistently and verifiably. The computer system validation process covers every function and milestone of the computer system:

  • Development of the system
  • Operation of the system
  • The system’s maintenance
  • Its retirement
  • Archiving it

Documenting the computer system validation process is of critical importance, since this is what establishes that the computer system validation process is meeting its intended purpose.

The need for a computer system validation process

The computer system validation process is necessary for a number of important reasons:

The computer system validation process requirements

The organization carrying out the computer system validation process must do so keeping in mind its responsibility, which covers the following areas:

  • Standard Operating Procedures (SOPs)
  • Assessment of the inventory relating to the computer
  • Validation protocols that are specific to the system
  • Documentation of the validation protocols

In which areas is the computer system validation process necessary?

The computer system validation process is necessary to determine if the system requires to be validated for the following:

Computer system validation process relating to the hardware and software

The hardware and software are two important sections in which computer system validation process is needed. Good business practice requires that the organization designate a person entrusted with ensuring compliance with the computer system validation process for the hardware and software parts of a computer system.

Chalking up the Validation Master Plan

The computer system validation process gets crystallized into what is called the Validation Master Plan (VMP). This VMP consists of a plan to carry out the computer system validation process and includes:

  • Locating the set components during the validation process
  • Ranking and arranging the tasks according to their importance
  • Assigning responsibilities to the team
  • Identifying and forming procedures that are peculiar to the computer system validation process of the facility.

Steps for computer system validation process

The computer system validation process requires the following steps:

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