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”

Good Manufacturing Practices are essential for ensuring quality

Key Takeaway:

GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products.

Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products ranging from foods to pharmaceutical products; a few guidelines are required. These guidelines are collectively termed Good Manufacturing Practices(GMP).

Not a uniform set of standards

It needs to be understood that GMPs are not a uniform or homogeneous set of rules for everyone to follow. These are general principles laid out for ensuring that there is a minimum level of quality requirements to be fulfilled.

Agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products recommend these guidelines. These guidelines can be accomplished in many ways, and it is up to the organization to find out the one that suits it best and implement that system.

In essence, Good Manufacturing Practices can mean the following:

  • GMPs are set practices that manufacturers need to put in place to ensure that their products meet specified quality standards.
  • GMP guidelines consist of the minimum requirements that food product, drug or pharmaceutical manufacturers have to meet to assure that their products are of the prescribed quality and cause no harm or risk to those who consume them or the public at large
  • Regulatory agencies in several countries oversee their respective countries’ and global Good Manufacturing Practices. Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) are usually analogous to GMP
  • In many countries, legislations require pharmaceutical and medical device manufacturers to comply with GMP procedures. Many require these organizations to create their own GMP guidelines that are line with their legislations.

Basic points in GMP guidelines

These are the current GMP compliance requirements for pharmaceuticals (some of these guidelines overlap with those for medical devices)

 

goodManufacturingPractices.jpg

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

 

Article on “Statistical Sampling Plans for Medical Devices”

One of the important aspects of design control of medical devices is statistical sampling plans for medical devices. To gain an understanding of the idea of statistical sampling plans for medical devices, one needs to understand the process of medical device design controls.

Statistical sampling plans for medical devices needs to be seen in this background: Under Sec. 820.30 of Title 21 of Code of Federal Regulations (CRF) the FDA sets out requirements from medical device manufacturers -which want to market certain categories of medical devices in the US -for establishing and maintaining procedures to implements design controls into the device.

An understanding of design controls is necessary first

First of all, what are design controls? Design controls are linearly and logically described and recommended steps that manufacturers have to take for ensuring that they have developed what they meant to develop. In addition, design controls have to also be implemented to ensure that the final product is in line with the expectations and needs from the customer’s perspective.

Statistical sampling plans for medical devices come at a slightly later stage. Design controls pave way for the validation processes of design verification and design, which are done to ensure that the device design has met critical specifications or outputs and fulfill the requirements for the safety requirements, intended use, or specified application.

Verification and validation

This stage makes way for the next, which is fulfillment of design verification and validation (V&V), as required under Sec. 820.50 of 21 CFR. A core part of this code is the requirement from manufacturers for establishing and maintaining procedures to locate valid and proper statistical techniques for the process capability and product characteristics to be considered applicable. These are what constitute statistical sampling plans for medical devices

More of rule of thumb

Statistical sampling plans for medical devices need to be written and based on a well-established statistical foundation. However, the FDA does not prescribe a formal plan for writing down statistical sampling plans for medical devices. These are to be based more on rule of thumb. In other words, there are no acceptable limits violations under statistical sampling plans for medical devices. The statistical sampling plans for medical devices need to be implemented on a case-to-case basis, based on the device’s characteristics and features.

In arriving at statistical sampling plans for medical devices, the FDA sets out the following rule:

Table 1

Binomial Staged Sampling Plans

Binomial Confidence Levels

able 2

Binomial Staged Sampling Plans

Binomial Confidence Levels

ucl = Upper Confidence Level

These constitute the core guidance for statistical sampling plans for medical devices.

Learn more on this topic by visiting: Article on “Statistical Sampling Plans for Medical Devices”

Leadership Management Academy 201-202: Rising Through the Management Ranks 2017

 

Overview:

Why Should You Attend?

By attending, you will take advantage of a great opportunity to advance as a manager to the next level!

Too often, we focus on getting things done and results and miss working on our self-development. Let’s face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It’s time to get ahead! Don’t miss an opportunity to advance as a manager again!

We’ll take you through peer discussions addressing leading and managing, integrating finance and quality, managing your time effectively, managing performance and managing up.

Join us as we help you report back to your manager that “I’m ready to take the next step in advancing my management career!”

 

Why should you attend :

By attending, you will understand how to even more effectively:

  • Lead and manage
  • Integrate finance and quality in your organization
  • Manage your time, including prioritizing
  • Manage performance
  • Understand behavioral styles, so you can manage more effectively
  • Handle performance conversations, especially difficult conversations
  • Coach with purpose and focus
  • Manage to Action Plans, both by your team members and yourself
  • Build teams
  • Integrate performance improvement and quality improvement
  • Manage your manager, manage up

Are you concerned about getting ahead, taking the next step in your management career, yet you never seem to have the time?

Would you like to get a better handle on those difficult “performance conversations” you have to have?

Would it make a difference if you could coach more effectively with purpose and focus?

Would you like to improve your management skills to the point where everyone on your team is taking action to achieve results every day?

If you answered “yes” to any of these questions, then come laugh, listen and learn as Chris DeVany leads us all through these important topics, key questions and answers we all need to be able to address effectively to improve our team members’ and team’s performance, all of which helps us manage even more affectively and rise up the corporate ladder!

Areas Covered in the Session:

Leading and Managing

    • Coping with new roles as leaders
    • The differences between leading and managing
    • Leading effectively – best practices
    • Managing effectively – best practices

Integrating Finance and Quality in Our Organization

    • Quality Management
      • How are we managing quality in our organization?
      • Best practices
      • Improving quality and quality management
    • Quality and Cost – Drive down labor and supply costs while improving the quality of products and service provided
    • Management Integration – Find the right structure, align incentives, and engage managers in business and process improvements.
    • Revenue Cycle – Implement the cultural, process, technology, and talent strategies that will get better results with limited resources.
    • Budgeting — Planning, Implementing and Evaluating

Managing Time Effectively / Prioritizing

    • How we can be more efficient and effective
    • Determining priorities and focusing on the important (time management/delegation)
    • LEM goals
    • Managing increasingly multiple priorities and working relationships

Managing Performance

    • Understanding Behavior, Managing Performance Within a Behavioral Context
      • Behavioral styles – how can we quantify behavior interactions with customers and with co-workers
      • Evaluating behavior
        • Understanding behavioral tendencies (DiSC – Dominant, Influencing, Steady and Cautious) and addressing when reviewing performance
    • Performance Conversations, Difficult Conversations
    • How to have those conversations with employees (crucial performance conversations)
    • Coaching and mentoring – especially with those who are under-performing
      • Why might people not be performing well – understanding and addressing
      • Integrating coaching with performance conversations.
    • Action Planning
    • Follow-up to those conversations
      • Monitoring the Action Plan
      • Modeling the behavior we expect
      • Monitoring and reviewing of Action Plans
    • Performance Reviews
      • Working with HR for conducting performance reviews objectively
      • Managing and implementing Professional Development Plans (PDPs)
      • The importance of documenting performance
      • Letting someone go legally and professionally while protecting yourself at the same time
    • Integrating Performance Improvement and Quality Improvement
      • Taking this to the next level – follow-through – continuing that improvement
    • Team-Building
      • Keeping the environment positive while effectively managing performance
      • Supporting employee morale and job satisfaction – tips and techniques we can use
      • Building/sustaining a cohesive team – accountability
  • Managing Up
    • Managing your manager
    • Dealing with senior management
    • Managing new and evolving working relationships – how do you push back without pushing back
    • Persuasion influencing, (up) and negotiating up

 

Who will benefit:

  • CEO
  • Senior Vice President
  • Vice President
  • Executive Director
  • Managing Director
  • Regional Vice President
  • Area Supervisor
  • Manager

 

 

 

Agenda:

Lecture 1: Leading and Managing

Lecture 2: Integrating Finance and Quality – Part 1

Lecture 3: Integrating Finance and Quality – Part 2

Lecture 4: Managing Time Effectively – Part 1

 

Day 2 Schedule

Lecture 1: Managing Time Effectively – Part 2

Lecture 2: Managing Performance – Part 1

Lecture 3: Managing Performance – Part 2

Lecture 4: Managing Your Manager, Managing Up

 

 

Speaker:

Chris DeVany,

Founder and President, Pinnacle Performance Improvement Worldwide,

Chris DeVany is the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organization development. Pinnacle’s clients include global organizations such as Visa International, Cadence Design Systems, Coca Cola, Sprint, Microsoft, Aviva Insurance, Schlumberger and over 500 other organizations in 22 countries. He also has consulted to government agencies from the United States, the Royal Government of Saudi Arabia, Canada, Cayman Islands and the United Kingdom.

He has published numerous articles in the fields of surviving mergers and acquisitions, surviving change, project management, management, sales, team-building, leadership, ethics, customer service, diversity and work-life balance, in publications ranging from ASTD/Performance In Practice to Customer Service Management. His book, “90 Days to a High-Performance Team“, published by McGraw Hill and often accompanied by in-person, facilitated instruction, has helped and continues to help thousands of executives, managers and team leaders improve performance.

He has appeared hundreds of times on radio and television interview programs to discuss mergers and acquisitions (how to manage and survive them), project management, sales, customer service, effective workplace communication, management, handling rapid personal and organizational change and other topical business issues. He has served or is currently serving as a board member of the International Association of Facilitators, Sales and Marketing Executives International, American Management Association, American Society of Training and Development, Institute of Management Consultants, American Society of Association Executives, Meeting Professionals International and National Speakers Association. Chris is an award-winning Toastmaster’s International Competition speaker. He recently participated in the Fortune 500 Annual Management Forum as a speaker, panelist and seminar leader.

Chris has distinguished himself professionally by serving multiple corporations as manager and trainer of sales, operations, project management, IT, customer service and marketing professionals. Included among those business leaders are Prudential Insurance, Sprint, BayBank (now part of Bank of America), US Health Care and Marriott Corporation. He has assisted these organizations in mergers and acquisitions, facilitating post-merger and acquisition integration, developing project management, sales, customer service and marketing strategies, organizing inbound and outbound call center programs, training and development of management and new hires, and fostering corporate growth through creative change and innovation initiatives.

Chris holds degrees in management studies and organizational behavior from Boston University. He has traveled to 22 countries and 47 states in the course of his career.

 

 

Location: Raleigh, NC Date: April 27th & 28th, 2017 and Time: 8:30 AM to 5:30 PM

 

 

Venue: Courtyard Raleigh-Durham Airport

Address:  Courtyard Raleigh-Durham Airport   2001 Hospitality Ct, Morrisville, NC 27560, United States

 

Price:

 

Register now and save $200. (Early Bird)

 

Price: $1,195.00 (Seminar Fee for One Delegate)

 

Until March 15, Early Bird Price: $1,195.00 From March 16 to April 25, Regular Price: $1,395.00

 

Register for 5 attendees   Price: $3,585.00 $5,975.00 You Save: $2,390.00 (40%)*

 

Quick Contact:

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Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com

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Rising in one’s career through leadership management

Being a manager is an exercise in continuity. One does not become a manager and stop there. It is important to be, than to become managers. This means that management is a journey, not a destination. Because of this, continuous improvement is needed into this discipline from time to time.

Leadership management is needed to improve both the manager’s own self, and with it, the growth of the organization. Leadership management may be defined as the means by which one identifies, manages and sharpens one’s leadership capabilities. Why leadership management matters for organizations is that when leadership management is developed and refined with the right coaching, it can bring about tremendous change in the managers individually, for the whole team, and in the organization as a whole.

Leadership management is a tool for any ambitious manager

No manager who is ambitious likes to be left behind. It is the desire and ambition of any go-getting manager to stay ahead of her peers. The ways of doing this keep playing in the mind of any ambitious manager. Leading from the front and making a difference to her organization is always a priority for such self-driven managers.

Advancing professionally in one’s career and developing leadership management skills also give most managers a better grip on many practical aspects of management, which are not normally found in textbooks. The delicate performance conversations that they need to have from time to time with employees and the intention of making a difference by being able to coach their mentees more effectively, purposefully and with a strong sense of focus, are some of these.

Self-improvement and improvement for the organization

Leadership management brings about a sense of self-improvement of management skills, right up to the point of motivating the team to do the same on a daily basis. All this should reflect in improved positive results for the organization.

While all these are true; what is also equally true is that most managers hardly find the time to advance their careers. In keeping their sights on the managerial peak; most managers lose sight of leadership management and dilute their purpose. The culture in most organizations –that of getting things done in order to show results –is to blame for this.

In the process of working all the time to just show numbers; most managers lose sight of the more important goal of self-development, which often is at the core of leadership management. Advancing one’s own professional stature is the hallmark of leadership management and is as important as showing results for the organization. After all, a well lubricated, well-oiled managerial staff is the cog in the organization’s wheel.

Advancing within one’s own self as a manager by developing leadership management skills is extremely important, because a manager who is not growing from within cannot take the organization forwards. How does this happen? What are the ways by which managers can bring about leadership management? Is there an effective way of addressing issues concerning leadership management? What are the ways of improving it for the manager’s own good, which will result in benefits for the organization?

A complete understanding of leadership management  

All these will be part of a highly valuable, extremely interactive and entertaining session on leadership management. A two-day seminar on leadership management from GlobalCompliancePanel, a leading provider of professional trainings in all the areas of regulatory compliance, will show how to grow within the organization by focusing on leadership management.

This seminar will offer enjoyable lessons on management and self-improvement to such an extent that the participants laugh, listen and learn with the extremely lively Director of this seminar on leadership management, Chris DeVany.

To derive the immense benefit this seminar is going to impart, please register by visiting Rising in one’s career through leadership management .

Chris, the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organizational development; will lead participants though all these important topics and the key leadership management questions and answers that need to be addressed effectively if the manager has to play a major part in improving the team’s performance overall, as well as that of each member of the team.

An extremely useful session on leadership management

This seminar will be of immense use to all seekers of leadership management, as it will cover all the important aspects of leadership management. Peer discussions addressing leading and managing, integrating finance and quality, managing one’s time effectively, managing performance and managing up, are some of these.

Participants will be able to gain the following lessons on leadership management at the end of this highly useful session:

–       Lead and manage

–       Integrate finance and quality into their organization

–       Manage their time, including prioritizing

–       Manage performance

–       Understand behavioral styles, so they can manage more effectively

–       Handle performance conversations, especially difficult conversations

–       Coach with purpose and focus

–       Manage to Action Plans, both by the team members and oneself

–       Build teams

–       Integrate performance improvement and quality improvement

–       Manage one’s own manager, manage up.

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.