How to Prepare for FDA Submissions and Communicate Them With the FDA

A medical device company making a submission to the FDA on any of these: INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, and Post-Approval Supplements; needs practice and learning of all the intricate aspects of these activities. The FDA approval is necessary to start legal manufacturing a medical device or a combination product in the US. The FDA drug and device approval system is complex, and this understanding needs to be there on the part of the submitting company.

Of equal importance as the submission is how to communicate with the FDA about these at various stages before, during and after the submission. It calls for a thorough understanding of the regulations in all their detail. This complete understanding is necessary to sail through the filing process. Companies making the filing need to have an effective submission strategy, failing which they could invite enforcement actions from the FDA, not to speak of the waste of resources and time.

Complete learning all the aspects of FDA submission for medical devices and combination products

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering complete and clear understanding of these aspects of an FDA submission. David Dills, Global Regulatory Affairs & Compliance Consultant and President, NovaQual, will be the Director at this seminar.

David provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.

Understanding the regulatory requirements

David will explain all the details that need to go into an FDA submission to meet the regulatory requirements. FDA 510(k) submissions for obtaining FDA clearance, FDA Investigational Device Exemption (IDE) submissions for US clinical studies, FDA Requests for Classification and Requests for Determination, FDA Pre-Submission (Pre-sub) meetings, the PMA and its various submissions such as e.g. traditional, modular, streamlined, etc., the advantages and disadvantages of each, the Summary of Safety and Effectiveness Data (SSED) and the way in which to use it, determining when an IDE is required, and IDE, PMA and 510(k) submission management activities  are some of these.

This detailed session on FDA submissions and communicating with the FDA is of value to personnel in the pharmaceutical, biopharmaceutical, biologics and generic drug industry who are involved in preparing FDA submissions (INDs, NDAs, BLAs, ANDAs, post approval supplements). David has tailored the course content to suit the needs of those who interact with FDA staff, including Project Managers, Regulatory Affairs, Clinical, Nonclinical, Manufacturing, and Quality personnel.

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Ten-Step Process for COTS Risk-Based Computer System Validation

SaaS, short for Software as a Service, is a method by which applications are delivered over the Internet. Also called on-demand software, hosted software, or web-based software; SaaS removes the need to install and maintain software, all which can be done with just an Internet connection. SaaS applications can be run on the provider’s servers. Outsourcing is a major aspect of SaaS, because like in all other industries, most SaaS providers outsource their resources to cut costs.

Regulation for SaaS

This being the idea behind SaaS, it is necessary to understand the most essential element of such an activity: regulatory controls on SaaS providers. There are regulations such as 21 CFR Part 11, but these are only for the provider. Very few of these laws apply to the vendor. This being the case, it is entirely up to the regulated company to show compliance with the regulations and prevent issues relating to availability, performance and protection of data. With almost no regulation that will offer safeguards to the user from the vendor; ensuring compliance for both infrastructure qualification and Computer System Validation lies with the provider.

Any failure to show compliance affects the provider, because it is the provider, and not the vendor, that is regulated. It is the regulated provider that has to face FDA inspections on software validation and avoid FDA actions such as Warning Letters and 483’s. This makes it imperative for the regulated companies, software vendors and SaaS/cloud providers to take every step possible to comply with 21 CFR Part 11 and other regulations such as Annex 11. This is the only way to avoid legal and other issues associated with noncompliance.

Learning on SaaS compliance

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory industries, will explain these aspects of SaaS compliance. The Director of this seminar is David Nettleton, who is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and Computer System Validation.

Familiarizing participants with proven techniques

David will demonstrate proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. He will address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and Computer System Validation to impart this understanding.

The FDA performs both GxP and Part 11 inspections. The EMA has released an updated Annex 11 regulation that expands Part 11 requirements, and companies must update their systems and processes to maintain compliance. David will explain this in sufficient detail. Participants will get an understanding of the specific requirements associated with local and SaaS/cloud hosting solutions.

Validation of various specialized areas and processes

The FDA and the EMA require validation of almost every computerized system used in laboratory, clinical, manufacturing settings and in the quality process. David will explain how to achieve these by using a 10-step risk-based approach to Computer System Validation, with which they can narrow the time needed for software implementation and lower costs. He will examine recent FDA inspection trends and use these as examples to explain by ways by which core aspects such as document authoring, revision, review, and approval can be streamlined.

This seminar is of high value to professionals in the regulatory, clinical and IT areas of health care, clinical trial, biopharmaceutical, and medical device sectors that use computer systems to perform their job functions. Software vendors, auditors, and quality staff involved in GxP applications will also benefit immensely from this session.

What are the basic steps for implementing a project using Project Management methodology?

Sound project management lies at the heart of any work in organizations in any industry. This is because most work that gets done in organizations are projects in one or another sense. Any work, minor or major, works like projects, and take the same route in which projects are created and completed. This is why project management methodology is very important for organizations. This is the essence of project management.

When organizations take up projects without the right tools and the right plans, projects end up becoming more of wish lists than plans. So, what is project management, and what does it involve? This learning will be taught at a three-day seminar on project management that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing.

At this seminar, Mary McDonald, CEO, McDonald Consulting Group, will be the Director. A Project Management Institute (PMI) Project Management instructor with over 25 years’ experience in Project Management and Improvement at both with large multinational corporations and smaller groups; Mary has helped many organizations manage their projects by breaking them down into language that is understood easily by those who have not had formal Project Management training.

Project Management Overview for Auditors

In-depth understanding of project management skills

Projects need to be understood from various perspectives such as the size, the resources needed, the way of implementing it, the way of achieving the outcomes, and so on. At this seminar, Mary will explain the concept of project management in detail and why it needs to be understood thoroughly, and will provide tools that help in professionals understand and participate in a project.

Mary will take up a step-by-step approach to project management. The elements of a project start with writing a well drafted, clear and concise project statement. Mary will explain the ways of doing this. She will then explain the basic phases of Project Management, and show how to set up the project with measurable outcomes.

Nothing reinforces learning better than examples. Keeping this in mind, Mary will offer a relatable, real-life example of how to set up the schedule and break a project down to manageable tasks. She will also describe what it takes to work on a project in the midst of workloads and will show how to maintain existing and ongoing work while working on projects.

Handling risks in projects

Tracking the progress of a project is very important to the outcome. Mary will show how to do this effectively. She will also explain another very crucial aspect of project management, namely assessing and mitigating the risk associated with the Project. Finally, she will also show how to review a glossary of Project Management terms.

In this course on project management for professionals at beginner level that want to understand project management, as well as those who need to refresh their project management skills so that they may explain these to the rookie, Mary will cover the following areas:

• Write a clear and concise project statement
• Define the Four Phases of a Project
• Set up and monitor Project measurables.
• Understand the roles and responsibilities of each member in the Project Team
• Break down a Project into smaller tasks
• Schedule the work around existing commitments
• Discuss tools for Project Management (Visio and MS Project)
• Identify and mitigate risks associated with the projects
• Define Project Management terms and concepts.

 

 

How to effectively write an SOP to ensure compliance

What is an SOP? In an organization, it is an operation-specific procedure that gives a thorough description of all the activities needed to carry out tasks that comply with industry-related regulations, State laws, and many a time, the methods the organization itself has prescribed for its business. Documentation is at the heart of a solid SOP. The core of developing an SOP is how the organization systematizes its processes and documents them.

A procedure must necessarily describe the manner in which to carry out a certain activity, or what is called the “how to” of it. SOPs are a set of standards, procedures, principles and policies that go on to streamline core areas such as finance, HR, administration, marketing and many others.

Many advantages and benefits accrue from putting in place a sound SOP. These are some of them:

• The organization’s efficiencies go up
• They help put in place a healthy workplace environment, and help meet regulatory requirements
• The organization’s products and services carry higher quality, and are more consistent and reliable
• The error rate in most activities comes down
• SOPs are a ready reference to resolving disputes between Business Associates.

Complete understanding of SOPs

Want to understand the nitty-gritty of how to implement an SOP that meets all these requirements, and helps your organization reach its business and other goals? A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will show you how.

Peggy Berry, President & CEO, Synergy Consulting, where she provides consulting services to companies in all aspects of drug development, will be the Director of this seminar. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. In an earlier role, she was an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).

 

An understanding of how to write SOPs

Peggy will lead the participants into an exploration of important aspects of SOPs, such as what they are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs.

An SOP is a set of standardized procedures and processes and should have as much detail in it as to ensure that tasks are performed consistently each time they are done. SOPs should comply with domestic, regional and global regulations and guidelines across all the functions they describe. It is not uncommon to come across reference to lack of SOPs or not following SOPs as frequent reasons for citations by the regulatory agencies around the world. Whenever this happens, organizations must correct those SOP-related deficiencies.

At this seminar, Peggy will explain all these aspects of SOPs. She will cover the following areas:

• Regulatory requirements for GCP SOPs
• Regulatory requirements for GMP SOPs
• Legal requirements for SOP creation and maintenance
• Types of SOPs
• Formats and essential components of SOPs
• How to effectively write an SOP to ensure compliance
• SOP training and implementation
• Deviations from and changes to SOPs.

Professionals at all important levels of an organization that deal with SOPs will benefit immensely from this session. These include Directors, Managers, Supervisors, Auditors, those in regulatory operations, Clinical investigators, site managers and contracting personnel, Project managers, medical writers, Compliance officers, and those in the areas of clinical operations and data management.

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Principles & Best Practices for Qualifying Cloud Infrastructure

Businesses that work in GxP-regulated industries need to validate their GxP computerized applications for carrying on their day-to-day operations. A reliable, qualified infrastructure provides control and regulatory compliance of these applications. A noncompliant IT Infrastructure leads to failure of an entire site, and can bring an entire geographic area to a halt till the compliance issue is resolved. Inviting regulatory citations is another consequence of having a noncompliant IT infrastructure.

What happens in such a scenario? A regulated company can have its products recalled, and it can invite warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. Data integrity can also lead to potential patient harm.

Now, what are the benefits of having a compliant IT infrastructure in place? It leads to the following:

• GxP compliance
• Increased adaptability and agility necessary for a changeable environment
• Guaranteed interoperability among organizational and external entities
• Establishment of effective change management policies and practices
• Adherence to standards
• Elimination of duplication of effort
• Enhanced flow of information throughout an information system.

A risk-based approach

A risk based approach to meeting current regulatory expectations for developing compliant IT infrastructure platforms, including the need to identify, qualify and control those aspects impacted by GxP quality and data integrity, will help meet the requirements of qualifying IT infrastructure in a compliant manner.

The knowledge needed for doing this will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. At this seminar, Angela Bazigos, whose is CEO of Touchstone Technologies Silicon Valley, will be the Director.

All about IT infrastructure qualification

The aim of this teaching is to provide current best practices for the design, qualification and operation of an IT infrastructure with a strong emphasis on the qualification requirements of the major components. Angela will explain how to show compliance with international GxP regulations. This compliance can be used both for the establishment of new platforms and extensions or existing platforms whether or not they are currently in support of GxP applications.

Angela will also take up for discussion a range of IT infrastructures, from those found in companies operating in a global setting to isolated or semi-isolated GxP infrastructures. She will emphasize on the horizontal approach to IT Infrastructure Qualification which brings many benefits, such as a higher level of standardization throughout the entire lifecycle, and highly reduced overlaps in the documentation, qualification and in audits inspections and assessments.

The important aspect of learning over the two days of this seminar are the different platform components and how to adapt a generic qualification strategy for each of these. The Director will cover a range of IT Infrastructures, both cloud and non-cloud, from those found in companies operating globally to isolated or semi-isolated GxP regulated infrastructures.

Angela will cover the following areas at this seminar:

• How does IT Infrastructure Qualification fit into GaMP5 lifecycle?
• Quality Management for Infrastructure
• Risk management for Infrastructure Qualification
• Installation & Operational Qualification of Infrastructure Components
• Configuration management and change control of infrastructure components and settings in a highly dynamic environment
• Involvement of service provider in critical infrastructure processes
• Security management in relation to access controls, availability of services and data integrity
• Backup, restore and disaster recovery of IT infrastructure.

 

Learn from surviving to thriving of a Quality Management System

An efficient and effective Quality Management System (QMS) lies at the heart of a medical device company. Why do so many companies struggle to establish and maintain an efficient and effective QMS? Simple: not only is an efficient and effective QMS necessary to establish quality of the products; it is a regulatory requirement. Regulatory agencies such as the FDA lay heavy and overarching emphasis on a medical device company’ QMS.

At the other end of the spectrum, there are grave consequences to be suffered when a medical device organization fails to put in place an efficient and effective QMS. A weak and faulty QMS can lead all the way from medical device reports to FDA recalls, and from 483s to Warning Letters. And an inefficient QMS results in wasted time, money, and missed opportunities.

And yes, the most important damage an ineffective QMS can result in is a bunch of negative consequences including serious injury, or even death for the user, which can result in lawsuits. A poor QMS also alienates the customer. All these point to the critical need for medical device companies to establish a thoroughly efficient and effective QMS.

Learning on how to build a proper QMS

A valuable two-day seminar from GlobalCompliancePanel a leading provider of professional training for all the areas of regulatory compliance, will show how to establish an efficient and effective QMS that meets regulatory requirements. This is the basis to experiencing all the benefits that such a system brings for the organization.

Susanne Manz, Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc., will be the Director at this two-day seminar. An accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma; Susanne brings an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.

From surviving to thriving

Susanne will instill learning on how to establish an efficient and effective QMS though lectures, exercises, and discussion, which will put the participants on the path to a thorough understanding of the fundamentals of a Quality Management System. The core of this discussion is to help them take their program from surviving to thriving. Creating a sound QMS may help the organization survive FDA scrutiny, but building a thriving QMS can take the organization to a higher plane, which includes achieving their compliance objectives and improving product quality, the result of which is obvious: higher customer satisfaction and increased ROI.

Susanne will take the participants of this seminar from understanding the regulatory requirements to how to create your QMS structure. She will inculcate the method of process thinking that helps them put in an improved strategy. She will also show them the improvement tools and techniques that help them measure their progress.

Susanne will cover the following areas at this seminar:

• Essentials of an effective QMS
• Essentials of an efficient QMS
• Quality is not an Organization
• Key Capabilities
• Maturity Modeling
• Vision, Strategy, and Quality Planning
• Improvement Tools
• Best Practices.

This course has been created to benefit all personnel in a medical device company that are concerned with and related to a QMS, including Quality Systems Specialists, Quality and Compliance Specialists, Auditors, Quality and Compliance Managers and Directors, CAPA Specialists, Project Managers, Supplier Quality Engineers and Auditors, Quality Engineers, Management Representatives, and General Managers.

Learning Management Systems for Pharmaceutical Companies

When it comes to organizing and streamlining learning, few tools can beat Learning Management Systems (LMS). An LMS in the pharma industry serves very important purposes in assuring and demonstrating that employees in the pharmaceutical organization schedule and undertake their training for any discipline as and when required in the light of the issuance of new guidelines, or development of new technologies, and keep their GMP compliance up to date.

An LMS is normally customized for the industry for which it is built, and for the organization which takes up the training. With the varied mix of functionalities that present-day LMS come with, the task of organizing trainings is made simpler and cheaper. But like all tools built on technologies; LMS too come with their own set of limitations. The pharma company that imparts training through an LMS has to be aware of these.

Want to understand how to choose and set up an LMS that is appropriate to the pharma industry and tailored specifically to your organization’s training needs in a way that the training becomes effective and the drawbacks neutralized to the extent possible?

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Laying high emphasis on framing the curricula

Identifying and overcoming the limitations of an LMS that is built for the pharma industry, as on how to adapt and implement one that is suited for the industry and the respective organization. He will also devote considerable attention to a critical, yet often overlooked and less understood area of a pharma LMS: the development of training curricula in these systems.

Much like SOPs, curricula for LMS are controlled documents that require stringent overseeing, review and signature. The curricula should continually document the review of the company’s SOPs, and so, change every time an SOP is created or revised. Another characteristic of an LMS curriculum is that the curriculum owner may need training to become authorized to approve a curriculum.

Most pharma companies often consider the curricular aspects of an LMS as a given, seldom realizing that the curriculum is an area that comes with its own unique challenges and usually takes a lot more time to implement than one would like to think. It is critical for organizations to designate a qualified and preferably, experienced individual for creating and designing the curricula for the LMS and delegate ownership of this core function to this individual.

Designating the right person

This calls for the selection of the right person, who has to have a thorough understanding of the training needs, as well as the roles and responsibilities of the staff members that partake training through the LMS. In the context of the pharma industry; the inclusion of assessments (knowledge or skill) is a must for curricula needed for GMP-regulated tasks that the user performs directly.

Ideally, the pharma curriculum should aggregate all the courses that an employee in a specific position requires, and should consist of smaller groups of courses called modules. The curriculum typically should have the following:

• What may be called a “core curriculum” -usually an assortment of several modules-with all the required courses for all employees involved in GMP functions
• A “job-specific” group of courses for the position
• Modules reflecting further subdivision of responsibilities within individual positions
• Roles in validated computer systems such as investigations
• Roles in applicable hard-copy review processes.

A factor that normally inhibits the development of an appropriate curriculum is that those in charge of framing it are not professionals who specialize in this domain, but are employees of the organization who have other responsibilities, for whom chalking up the curriculum for the LMS is only an additional responsibility.

This seminar will describe the development of job position curricula in the pharmaceutical industry using a Learning Management System (LMS) and provide you with the tools needed to create effective curricula.

Aspects of an effective LMS those we need to know:

• What a true Pharma curriculum is
• Requirements for Pharma curricula
• What a true Pharma curriculum is not
• Why is setting up curricula so complicated?
• Obtain details of employee job functions that are necessary for setting up curricula
• Demos and hands-on activities for employees
• Knowledge assessment and review.