Seminar Calendar of Upcoming Courses – June to July – 2017

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GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

The ingredients of a truly effective internal audit program

 

AFirst Sliden internal audit program of an organization’s Quality Management Systems is a core requirement from both the ISO and the FDA. At its barest, an internal audit system can be understood to be an assessment or inspection of an organization’s Quality System. Audits are a very beneficial and positive tool for continually ensuring that an organization’s internal management systems are up to the mark and keep meeting regulatory requirements on a consistent basis.

An internal audit program is the most effective and useful tool in helping an organization discover its loopholes and deficiencies in the Quality System, which is absolutely essential to help it pass regulatory hurdles. The purposes of an internal audit, as set out by ISO 9001, which describes Quality Management Systems audits, are to ensure that:

  • The Quality Systems of the organization comply with the requirements of ISO 9001 and its latest versions
  • They show compliance with the requirements of other regulatory bodies such as the FDA
  • They comply with the quality requirements the organization has
  • The organization makes effective implementation and maintenance of the QMS.

ISO 9001 does not require the internal audit procedure to be fully documented. An organization has to only, to use the ISO’s own words, “maintain an audit program” and retain the documents relating to the audit and its results and information contained in them.

Multifold benefits of auditing

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Auditing, both external and internal, bring many benefits. Besides meeting the purposes as set out by ISO 9001 and others such as the FDA; auditing helps organizations:

  • Identify the areas in which they need to make improvements
  • Apply best practice relevant to the particular industry
  • Take preventive actions that could nip potential problems in the bud
  • Ensure greater customer satisfaction.

Compliance with audit requirements is considered drudgery

Despite the noble intentions behind internal and external audits; three fourths of organizations consider audits as being very cumbersome, unpleasant and baneful. Most of them carry out audits with no conviction. They carry them out only because they have no other choice. Most businesses fail to see the value behind the efforts needed for carrying out audits that meet regulatory requirements.

Carrying out audits without any sense of purpose results in more drudgery and unpleasantness. The result of carrying out audits for the sake of it, rather than with purpose is there to see: More Warning Letters, 483’s, penalties and other actions such as even Consent Decree, from the FDA.

Learn to carry out effective audits more willingly and effectively

The ways by which organizations can overcome the mental barrier to carrying out audits and put in place a well-planned, compliant audit program that reduces the risk of noncompliance will be the teaching a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulated industries, will be offering.

Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc., who is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, will be the Director of this seminar. To enroll for this webinar and gain complete understanding of the means for planning and implementing a Quality Systems audit that meets regulatory requirements,

Please register by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900854SEMINAR?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 complete understanding of the rationale and ways of carrying out compliant audits

This seminar will be highly useful in helping audit professionals in organizations devise an effective audit program with is compliant. It will put participants on the path to a thorough quality audit program that meets regulatory requirements. Such a well devised quality audit program is a powerful tool in helping organizations to understand, reduce and communicate risks relating to quality and compliance.

Susanne will open the participants’ minds to continuous improvement, which starts with the awareness of issues and opportunities. The absence of an effective audit program deprives management of an understanding of the issues within their Quality System. As a result, management is oblivious to the lacunae in the Quality System and the risk bring for the organization. Such a situation denies the management the opportunity to assess the impact a faulty Quality Management System audit has on product quality and the risk it poses to the customer. Susanne will draw participants’ attention and focus on the red-flags and explain to them the ways by which they can reduce compliance and quality risk.

This seminar will consist primarily of lectures, interactive discussions and practical exercises. Susanne will equip the participants with the tools and techniques they need for ensuring compliance of their Quality Systems audits. They will walk away with an understanding of the key concepts and their practices, along with the ways of implementing them and use them as reference for future use

 

FDA requirements on data integrity and its implementation

The phrase “data integrity” seems to be everywhere. It is used in a number of places and situations, and the FDA has its own definition of the term. At its plainest, data integrity is defined as the assurance that data is complete, consistent and accurate. FDA requires this data to be attributable, legible, contemporaneously recorded, to be an original or a true copy, and to be accurate. This criterion is embodied in the acronym ALCOA.

Is just an understanding of this definition sufficient? In order to understand data integrity from the computerized systems point of view; one has to apply 21 CFR Part 11 and Annex 11 to data. Its implementation is considered difficult for a number of reasons. To apply data integrity to computer systems, one needs to understand the concept of data integrity.

Understanding is necessary in view of the FDA’s stepped up inspections

It is only this basic understanding that will help to determine what needs to be done to meet national and global data integrity requirements. This is all the more important in view of the fact that regulatory agencies such as the FDA have accelerated inspections related to data integrity, as a result of which there has been a big rise in the number of citations relating to data integrity.

When it comes to data integrity for computerized systems, the requirements set out in 21 CFR Part 11 and Annex 11 need to be kept in mind from the following perspectives:

o  The background to and the way in which 21 CFR Part 11 and Annex 11 have evolved and why they are being talked about all over again

o  An understanding of the full overview of Part 11 and Annex 11 and their key requirements

o  Clear understanding of how the use of Risk Based Assessment will not only achieve data integrity and compliance but also bring down work considerably

o  The FDA’s and other regulatory authorities’ method of inspecting computerized systems for data integrity.

A complete two-day exploration of data integrity from the FDA’s perspective

It is to familiarize IT professionals and professionals who work on data integrity that GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance will be organizing a two-day seminar.

The Director of this seminar is Angela Bazigos, who is CEO of Touchstone Technologies Silicon Valley. Angela brings over 40 years in the healthcare and life sciences industries. To gain the benefit of Angela’s experience in the industry and to discover ways of ensuring data integrity in the computer systems of a number of healthcare and life sciences disciplines, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900946SEMINAR?wordpress_SEO . This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Practical understanding of data integrity

This seminar is very hands-on and is meant to offer guidance on how to ensure data integrity in highly regulated industries. It is of relevance and importance to both beginners and experienced professionals alike. She will offer a completely detailed experience of validation and 21 CFR Part 11 compliance that a computer system needs to have.

One of the major takeaways of this seminar is the templates Angela will give to participants, which will help them build a full package for meeting data integrity for computerized systems. She will also detail the activities associated with Computer Systems Validation, exploring areas such as:

o  What is Data Integrity and how is it implemented

o  How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?

o  Data Integrity Frequently Asked Questions

o  Validation Master Plan

o  Risk Based Assessment

o  Complete Validation for a System (software development lifecycle)

o  Automated Test Tools

o  Infrastructure Requirements

o  Change Control

o  SOPs.

https://www.fda.gov/downloads/drugs/guidances/ucm495891.pdf

Article on “A Tour of the FDA”

A tour of the FDA is something like a snapshot of what the FDA does. The importance of the FDA can never be understated: It regulates products from the proverbial pin to airplane in the food, medical devices, pharma and healthcare industries, which touch almost every aspect of American lives. The products that the FDA regulates account for about a trillion dollars, which make up about a quarter of all goods traded in the US.

So, what is a tour of the FDA like?

A tour of the FDA helps to get a broad understanding of the this regulatory body and get some idea of the various departments it has, as well as the functions of these departments. To get an understanding of what the FDA does, a reference to its mission statement could give some direction:

“(The) FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” This is just the opening line of the FDA’s mission statement. Reference to its other statements, which have now included a reference to containing terrorism, will serve as a good guide to a tour of the FDA. In short, the FDA regulates nearly every item used and consumed by the American public.

The history of the FDA

The legal sanction for carrying out its mission is mandated by the Federal Food, Drug and Cosmetic Act (FD&C Act). An amazing fact that a tour of the FDA reveals is that it is one of the oldest regulatory bodies in the world, with its earliest jurisdiction having covered regulation of drugs in the year 1848. The Department of Agriculture, to which President James Polk appointed noted chemist Charles Wetherill, can be considered the earliest endeavor to regulate medical products of daily use in the US.

How is the FDA organized?

A tour of the FDA is incomplete without a reference to the way it is organized. Its structure consists of this hierarchy:

  • Office of the Commissioner
  • Office of Foods and Veterinary Medicine
  • Office of Global Regulatory Operations and Policy
  • Office of Medical Products and Tobacco
  • Office of Operations

Under these broad heads, a tour of the FDA shows the way into which it is divided into several offices and organizations. Important among these include:

  • Office of Regulatory Affairs (ORA)
  • Center for Food Safety and Applied Nutrition (CFSAN)
  • Center for Drug Evaluation and Research (CDER)
  • Center for Biologics Evaluation and Research (CBER)
  • Center for Devices and Radiological Health (CDRH)
  • Center for Devices and Radiological Health (CDRH)
  • National Center for Toxicological Research (NCTR)

Want to know more: Article on “A Tour of the FDA”

Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

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 Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA) . 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

 

FDA and EU requirements on data integrity and implementation

Data integrity and its implementation in cGMP records are major requirements from the FDA. The FDA considers these as important requirements to ensure the integrity of data in these records. The FDA’s, as well as the EU’s requirements are set out for ensuring both data integrity and its implementation are set out in 21 CFR Part 11 and Annex 11 respectively.

Data integrity is part of FDA 21 CFR Part 11, which essentially deals with the veracity of electronic records and electronic signatures. It applies to records designated or set forth in Parts 210, 211 and 212 of FDA regulations. The FDA’s 21 CFR Part 11 has its counterpart in Eudralex Annex 11, which also has more or less the same intention, but varies in some ways. Both the FDA’s 21 CFR Part 11 and Annex 11 are required for medicines that are introduced into the US and European markets. Annex 11 is basically about the implementation part of cGMP records.

What is data integrity?

First, a small understanding of data integrity: The FDA defines data integrity as a state in which the data is complete, consistent and accurate. The FDA uses the acronym ALCOA to describe this quality of data: Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate.  The requirements set out by the FDA on data integrity are applicable to metadata and audit trails as well, as also static and dynamic data. Static data is a physical record of which a paper record is an example. By contrast, dynamic data is the kind of record in which it is possible to make some interaction between the user and the creator.

Part 11 lists out criteria that the FDA considers all these: electronic signatures, handwritten signatures and electronic records that are done on electronic records to be reliable, truthful, and generally the same as paper records and handwritten signatures that are done on paper.

Get to understand 21 CFR Part 11 and Annex 11 better

The ways of actually ensuring and implementing data integrity as set out in both FDA 21 CFR Part 11 and Annex 11 of the Eudralex will be the learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings in the areas of regulatory compliance, will be imparting.

At this seminar, Angela Bazigos, CEO of Touchstone Technologies Silicon Valley, and a senior Regulatory Affairs professional who carries four decades of experience in regulatory affairs, will be the Director. To enroll for this highly enriching learning session on FDA 21 CFR Part 11 and Annex 11, please register for this session by visiting FDA and EU requirements on data integrity and implementation . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Explaining the history of these regulations

Angela will start this seminar with an explanation of how 21 CFR Part 11 and Annex 11 evolved, which will set the background to these laws. She will explain why these two regulations are now being talked about all over again. Offering an overview and key requirements of Part 11 & Annex 11, Angela will describe how to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance. She will then also illustrate how the FDA & other regulatory authorities inspect computerized systems for data integrity.

During the course of this seminar, the Director will cover the following areas:

o  What is Data Integrity and how is it implemented

o  How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?

o  Data Integrity Frequently Asked Questions

o  Validation Master Plan

o  Risk Based Assessment

o  Complete Validation for a System (software development lifecycle)

o  Automated Test Tools

o  Infrastructure Requirements

o  Change Control

o  SOPs.

 

Applied Statistics for FDA Process Validation

The pharmaceutical industry considers Applied Statistics for FDA Process Validation to be of very high importance. In 2011, the FDA set out this guidance for the industry. as part of this guidance, called “Process Validation: General Principles and Practices”, which sets the framework for Process Validation in the pharmaceutical industry, any organization in the pharmaceutical industry has to set up a three-stage process.

These are the three stages:

I.           Process Design

II.           Process Qualification, and

III.           Continued Process Verification.

Stage 1, or what is called the Process Design stage, is the stage in which the commercial manufacturing process is defined. This definition is based on knowledge gained through development and scale-up activities.

Stage 2, called the Process Qualification, is the stage in which an evaluation is made of the process design to determine if the process is capable of reproducible commercial manufacturing.

Stage 3, the Continued Process Verification, is meant for giving ongoing assurance during routine production to ensure that the process remains in a state of control.

A seminar on the ways implementing Applied Statistics for FDA Process Validation

GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing a two-day seminar in which the ways of using Applied Statistics for FDA Process Validation will be taught. Richard Burdick, Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc., will be the Director of this seminar on applied statistics for FDA Process Validation.

In order to learn Applied Statistics for FDA Process Validation in-depth, please register by visiting Applied Statistics for FDA Process Validation. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A detailed and methodical approach to implementing statistical methodologies

This two-day course on Applied Statistics for FDA Process Validation will focus on the ways by which a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance can be established.

Beginning with a primer on statistics, Dr. Burdick will explain how the methods of Applied Statistics for FDA Process Validation seminar can be applied in each remaining chapter.

Dr. Burdick will next move on to explaining the two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays).

He well then show how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Given that the methods taught through all these three stages are recommended by regulatory guidance documents; this seminar on Applied Statistics for FDA Process Validation will provide references to the specific citations in the guidance documents.

This seminar on Applied Statistics for FDA Process Validation will lead participants into ways of establishing a systematic approach to implementing statistical methodologies into a process development and validation program that is consistent with the FDA guidance.

All-round learning related to Applied Statistics for FDA Process Validation

Dr. Burdick will teach participants how to:

o  Apply statistics for setting specifications

o  Assess measurement systems (assays)

o  Use Design of Experiments (DOE)

o  Develop a control plan as part of a risk management strategy, and

o  Ensure process control/capability.

All concepts at this Applied Statistics for FDA Process Validation seminar are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although established for the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation also provides a useful framework for other related industries.

In this important learning on Applied Statistics for FDA Process Validation; Dr. Burdick will cover the following areas:

o  Apply statistics to set specifications and validate measurement systems (assays)

o  Develop appropriate sample plans based on confidence and power

o  Implement suitable statistical methods into a process validation program for each of the three stages

o  Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)

o  Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ

o  Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.