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.

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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.

10-step risk-based approach to Computer System Validation

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.

SOP Development and Implementation for the FDA-Regulated Industry

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.

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A Risk Based Approach To IT Infrastructure Qualification & Compliance

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.

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Evolution of the Quality Management System - How to go from Surviving to Thriving

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.

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Complete understanding of RCA and CAPA

All the learning Areas:

o    Regulatory Expectations for Investigations

o    What is RCA and Typical Problems

o    Investigation Process Overview

o    Skills and Tools of an Effective Investigator

o    (Re) Introduction to Root Cause Analysis (RCA)

• Principles of root cause analysis
• Why root cause analysis is difficult
• Methodology of root cause analysis

STEP 1 - Problem Definition

• How to ensure that the right problem is being worked on
• Tools and filters for priority setting
• Developing a clear and sufficient problem statement (includes practice)

STEP 2 - Understanding the Process

• How every problem is a process failure
• How diagrams can set boundaries and define interrelationships
• Using flowcharts to drill down into the right part of the process (includes practice)

STEP 3 - Identifying Possible Causes

• Multiple ways to identify possible causes
• Options for selecting or eliminating causes
• Logic trees as a cause and effect diagram and other tools for investigations

o    Defining the Deviation

o    Identifying Root Cause

o    Corrective and Preventive Actions (CAPA)

• What is the CAPA System
• Definition and regulatory interpretation
• Identifying and writing of corrective actions
• Abuses of the CAPA system
• Discuss robustness and effectiveness review

o    Management of the Investigation

o    Members of the Investigation Team

o    Consulting Case Study Practice - Incident/Events

o    Case Study Practice

o    Interactive Exercises and Discussions.

Complete understanding of RCA and CAPA