CYBER INCIDENT RESPONSE PROGRAM Is Bound To Make An Impact In Your Business

The idea is to help the organization preempt attacks by roleplaying an attacker, which will help it understand threats better and respond faster and more effectively.

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Organizations need an efficient Incident Response Program if they have to respond with speed and agility to a cyber incident. While such a program should empower businesses to maintain continuous operations; it should also reduce revenue loss, fines and lawsuits, and should help the business build a sound reputation for its brand.

Some of the key components involved in planning and executing the Information Security Plan include Information Security, Governance and Risk. The organization should have a clear map of who has the key responsibility for developing an information security governance program. It should be able to review existing Information Security policies and standards to assess their suitability and adequacy in relation to industry best practices, and be able to update them as appropriate, taking into account compliance recommendations.

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All these and more will be the learning a webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will be imparting. Michael Redmond, a Consultant, Speaker and Author who conducts ISO Certification Training for PECB, will be the speaker at this 60-minute webinar, which will be organized on April 15.

To gain insights into how to put a sound CSIRT program in place, please register for this webinar by visiting https://t2m.io/hd9phbb5

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At this session, Michael will help participants understand how to establish Key Performance Indicators (KPI) to determine if their Information Systems Incident Response program meets business objectives and operational metrics that facilitate ongoing process improvement. She will show organizations how to develop a CSIRT Policies, Program, Plan, Playbook, Training, and Exercises.

She will show the importance of coordination in incident handling, which will halt duplication of effort. In addition, she will also show how organizations should train their employees in a way that not only focuses on the capability to react to incidents but also have the ability to utilize the resources to alert and inform their stakeholders.

Methods such as tabletop tests, tabletop exercises and full Red Team Blue team training will be explained. The idea is to help the organization preempt attacks by roleplaying an attacker, which will help it understand threats better and respond faster and more effectively.

In this session, which is aimed at the benefit of Information Security Managers, CEO, CIO, CFO, CSO, Technology Managers and Auditors; Michael will cover the following areas:

  • Adopting a systematic approach to risk tracking to enhance the effectiveness of the Cyber Incident Program
  • Outlining the critical actions to take if an event affects the company or its partners
  • Understanding an organizations’ susceptibility to a Cyber Attack
  • Cyber Incident Response: Getting started, research, training, testing and maintaining
  • Standards and Best Practice: ISO 27001, ISO 27035, ISO 27005, ISO 22316 NIST, FFIEC, HIPPA, AND HITRUST.

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About the speaker: Michael is the Chapter President for Association of Contingency Planners Eastern Great Lake Chapter and an active member of ISSA. She has consulted in the area of Cyber Security for clients in the arenas of Healthcare, Insurance, Financial and Manufacturing. She has been named on the list of “Women of Distinction for 2015” by Women of Distinction Magazine for her work in Cyber Security.

Remember Your STATISTICAL METHODS Lesson? I’ve Got Some Tips…

The ways by which organizations can optimize their various data to enhance decision-making are vital for any organization.

Well, most organizations are experts at churning out mountain loads of data. They can produce data at the drop of a hat on any area of their work. But the crucial question is, how useful is this data? Are organizations using the right methods by which they can turn this data into useful and actionable information?

This is a core question for an organization. It is because the key to optimizing their operations and making effective decisions that help achieve a competitive advantage lies in the organizations’ and individuals’ ability to put the available data to the best possible use.

Obviously, organizations that don’t properly leverage data are bound to trail behind those who do. The ways by which organizations can optimize their various data to enhance decision-making are vital for any organization.

This knowledge will be imparted at a webinar that is being organized on March 20 by Compliance4All, a leading provider of professional training for all the areas of regulatory compliance. At this session, Steven Wachs, a senior statistician, will explain how to bring about a turnaround in organizational thinking when it comes to making use of data. Please visit https://t2m.io/cRPp46Py

Statistical Analysis

The aim of this webinar is to introduce participants to important statistical concepts and methods that are essential for making objective decisions related to product quality. A grasp of these concepts helps organizations to arrive at objective decisions to ensure and improve product quality. The methods he will introduce will open the participants’ perspectives to a host of critical lines of thinking, which include:

  • Determining how well the process/product meets requirements
  • Knowing when a process or system is behaving consistently or differently than before
  • Uncovering which key inputs to the process affect product performance or customer satisfaction
  • Ensuring that what needs to be done can be effectively measured
  • Comparing groups of data when a random (natural) variation is present
  • Predicting future outcomes using a predictive model

Steven will introduce a host of methods relating to statistical methods, which include:

  • Statistical Process Control
  • Process Capability Assessment
  • Regression Modeling
  • Design of Experiments
  • Hypothesis Testing
  • Measurement Systems Assessment.

Some of the methods whose purpose the participants of this webinar will gain an understanding of include:

  • Statistical Process Control
  • Process Capability Assessment
  • Regression Modeling
  • Design of Experiments
  • Hypothesis Testing
  • Measurement Systems Assessment.

Steven will cover the following areas at this webinar:

  • Variation & Quality
  • Process Stability/Statistical Process Control
  • Process Capability Assessment
  • Predictive Models (Regression & Design of Experiments)
  • Hypothesis Testing for Decision Making
  • Measurement Systems Assessment
  • Examples & Applications.

This webinar is aimed at benefiting personnel in various positions in the field of statistics, and these include:

  • Quality Personnel
  • Manufacturing Personnel
  • Operations/Production Managers
  • Production Supervisors
  • Supplier Quality personnel
  • Quality Engineering
  • Quality Assurance Managers, Engineers
  • Process or Manufacturing Engineers or Managers.

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About the speaker:

During his over 25 years of wide-ranging industry experience in both technical and management positions, Steven has worked in most areas of statistical applications in reputable organizations. He possesses expertise in the application of reliability methods to achieve robust and reliable products as well as estimate and reduce warranty.

In his current role of being Principal Statistician at Integral Concepts, Inc., he assists manufacturers in the application of statistical methods to reduce variation and improve quality and productivity. Steven regularly speaks at industry conferences and provides workshops in industrial statistical methods worldwide.

Quick ways to learn Standard Operating Procedure

It does not offer clear-cut guidelines on the right means to write, maintain, and update SOPs.

A Standard Operating Procedure (SOP) or a set of them is a sine qua non for organizations in the regulated industries. Yet, a lion’s share of the deficiencies that get detected during the FDA’s inspectional observations of organizations relates to problems in the SOP, for which these organizations get hauled up for enforcement actions.

However, the irony is that the blame for this situation lies with the FDA: while it mandates the need for SOPs among companies in the regulated industries, it does not offer clear-cut guidelines on the right means to write, maintain, and update SOPs.

It is mainly because of the absence of these guidelines that many organizations come up with SOPs that fail to meet regulatory compliance guidelines. The most common areas in which they falter are the manner of their writing, communication, monitoring and enforcement. The SOPs that most organizations write either fall short of the details or miss the tools for ensuring compliance with the SOPs. Most of these SOPs contain errors that end up getting noticed only during an audit.

A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show the proper ways of writing SOPs in a manner that makes it easy for companies to maintain and update these and to also avoid punitive actions from the FDA. The speaker at this webinar is Todd B. Graham, a clinical laboratory scientist for a large hospital system in the New York Tri-State Area. Please register for this 90-minute webinar by visiting http://write.news/compliance_SOP

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At this session on quick ways to learn Standard Operating Procedure, Todd will explain a set of guidelines that will educate the participants on how to write SOPs and work instructions for FDA-regulated organizations. This will help participants with:

  • Becoming familiar with the basics of how to generate a great SOP
  • Understanding how to remain compliant and yet not restrict the course of action
  • Gaining knowledge of how to maintain the compliance over the course of the SOP lifetime.

At this highly valuable, well-rounded learning on the proper ways of writing SOPs and work instructions that befit FDA-regulated organizations; Todd will cover the following areas:

  • Record compliance with examples
  • What are SOPs?
  • Why are they important?
  • What are their benefits?
  • What are their limitations?
  • Important types of SOPs
  • Minimum number for SOPs, topics, and examples
  • SOPs and guidelines

 Steps to develop an SOP

  • Process mapping
  • Authoring
  • Formatting and language
  • Editing
  • Authorizing
  • Training
  • Implementation
  • Revision / archiving (version control)
  • An SOP example and template

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About the speaker: In his role as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities, Todd has helped organizations improve sample workflow and laboratory quality and reduce sample turnaround time. Through his work, he has also helped expand laboratory services to vulnerable health populations in the New York area. Another of his pursuits has been to offer outreach services to the local community by serving as a mentor to not only students training in clinical laboratory science, but also the scientific community, which he has done by serving as a technical resource for his peers in the laboratory.

Need More Time? Read These Tips to Improve [Pharmaceutical Clean Rooms]

HVAC systems that meet the required regulatory particulate and microorganism levels that help meet quality requirements in the pharmaceutical product.

The proper and thorough understanding of the way in which a clean room’s HVAC system is designed and validated is critical for pharmaceutical professionals. This paves the way for creating the environmental control, a precondition for meeting the regulatory particulate and microorganism levels that are necessary for manufacturing a pharmaceutical product that meets quality expectations and requirements.

This makes environmental control of pharmaceutical clean rooms an indispensable element in the manufacture of a quality product. A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will explain how to set the right conditions to obtain a cleanroom’s HVAC systems that meet the required regulatory particulate and microorganism levels that help meet quality requirements in the pharmaceutical product.

This webinar, at which Roger Cowan, who is the founder and owner of R Cowan Consulting Services LLC will be the speaker, will be of 75 minutes’ duration and will be organized on March 18. To know more about how to improve pharmaceutical cleanrooms, please register for this webinar by logging on to https://t2m.io/Yn3dLyqB.

The main objective of this webinar is to underscore the criticality of the design, validation and ongoing monitoring of a clean room HVAC system in assuring both the quality and safety of the pharmaceutical product and to create a clean room environment that meets the compliance requirements set out by international regulatory standards.

Roger will explain Environmental Control vs. Environmental Monitoring, since the control of conditions such as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is vital to ensure the protection of the product from contamination.

He will also take up the various US and international regulatory requirements for various clean room classifications and then move on to comprehensive overview of the mechanics of clean room HVAC. He will reinforce the learning in this section by including engineering diagrams and schematics. Apart from detailing the HVAC equipment components and the automated control systems that are available, the speaker will also explain clean room design considerations. He will also emphasize the importance of proper building construction and layout for achieving both optimum efficiency of the system and optimum cleaning and sanitization of the clean room.

At this session, Roger will cover the following areas:

  • GMP Compliance of Clean Room Environment
  • Regulatory Clean Room Classification and Requirements
  • HVAC System Components
  • Clean Room Design and Layout
  • HEPA Filtration
  • Differential Pressure and Air Pressure Balancing Considerations
  • Temperature and Humidity Controls
  • Cleaning and Disinfection
  • Personnel Gowning and Aseptic Practices in Clean Room
  • HVAC System Validation.

This session is of high value and importance to professionals who work in cleanrooms, such as Quality Assurance, Environmental Monitoring, Microbiology, Manufacturing, Validation, Engineering and Maintenance.

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About the speaker:

Roger Cowan brings 37 years of experience in pharmaceutical quality assurance and manufacturing. His company specializes in consulting primarily in the area of pharmaceutical contract manufacturing. His areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US/International regulatory requirements, regulatory submissions, and quality assurance/control.

Immediate Actionable Tips on GMP Data Integrity

Data integrity and security violations are taken seriously from a 21 CFR Part 11 perspective and invite severe cGMP actions.

At its Current Good Manufacturing Practices (cGMP) inspections, the FDA has been increasingly observing CGMP violations involving data integrity of late. Failure to meet the requirements set out for GMP data integrity invites a host of regulatory actions, which can include Warning Letters, import alerts, and consent decrees.

So, what is data integrity? It is the means to assure that there is accuracy and completeness in data. The data should also have integrity, meaning it should be intact and be maintained within its original context. This can include its relationship with other data records. This definition relates to both data recorded in electronic and paper formats, or a hybrid of these two.

The integrity of laboratory data has been assuming greater importance in cGMP for the FDA-regulated industries in assuring the quality of raw materials, in-process materials and finished goods. Data integrity and security violations are taken seriously from a 21 CFR Part 11 perspective and invite severe cGMP actions.

Why does the FDA take data integrity so seriously? It is because any compromise in the integrity of laboratory data results in the failure of batches of finished goods to comply with the terms set out by the regulatory agency. Such batches will be barred from going on sale because of the many adverse consequences they could cause to the patient.

Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is offering complete understanding the regulatory expectations for data integrity at a webinar that it is organizing on March 11. Danielle DeLucy, who owns ASA Training and Consulting, LLC, which provides pharmaceutical and biologics based companies with training and Quality Systems assistance to help them meet regulatory compliance, will be the speaker at this webinar.

Please log on to https://t2m.io/fLgxhMyc to enroll for this webinar.

This session is of high value to professionals who are involved in GMP data in one or another way. These include Site Quality Operations Managers, Quality Assurance Personnel, Plant Managers and Supervisors, Manufacturing Superintendents and Managers, and Regulatory Affairs Managers.

The main learning offered at this webinar is the ability it will give to its participants on how to review practices at their own site and identify gaps in their practices. Danielle will help them understand the current regulatory position on data integrity and discover the criteria for data integrity. Participants will also learn about approaches to improve data integrity in a laboratory environment. She will offer them immediate actionable tips on GMP data integrity.

Danielle will cover the following areas at this webinar:

  • Understand the current regulatory position on data integrity
  • Discover the criteria for data integrity
  • Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
  • Learn about approaches to improve data integrity in a laboratory environment.

About the speaker:

Danielle has served several Quality Management roles in the over two decades she has been in the industry. She has helped to lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with Warning Letters and consent decrees and those wishing to improve compliance establish more robust Quality Systems to help these companies succeed.

Try These 3 Things When You Face an FDA Inspection

Which company roles should be assigned for these types of inspections, among other related topics.

Nothing perhaps rattles a regulatory professional as much as an FDA inspection! It can send the regulatory professional who is in charge of compliance into panic mode for a variety of reasons. As the one who faces the heat from the FDA directly, the regulatory professional is answerable to the FDA, most of whose questions are challenging and awkward. If anything goes wrong at any stage, it is the company that suffers.

Yet, an FDA inspection need not be the most nerve-wracking event of a regulatory professional’s career. When the professional is armed with a proper understanding of the regulations, planning, training, and most of all, with composure, an FDA inspection need not be the terror it is thought to be.

How does a regulatory professional face an FDA inspection with calmness? This is the understanding a webinar from Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is going to give. Please visit https://t2m.io/zLQHCuie to enroll for this session.

The three things to know when you face an FDA inspection

At this 60-minute webinar, which will be held on March 8, the highly venerated Jeff Kasoff, who is the Principal Consultant at Lean to Quality, LLC, will show how to tide over an FDA inspection without having to lose one’s nerve. The core areas that Jeff will cover at this session will include all that is needed to face an FDA inspection, including how to try these three things when you face an FDA inspection:

  • How to prepare for the inspection
  • What to do during the inspection and the close-out interview, and
  • How to respond to the inspection.

He will also give a clear understanding of the limits of FDA’s scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits. This understanding is necessary and important to help counter any uncomfortable situations during the inspection.

Professionals in the medical device and pharmaceutical industries will walk away with valuable information that they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

These are the key learning areas of the webinar:

  • Types of Inspections
  • Preparation
    • Dedicated personnel for inspection
    • Facility resources to support the inspection
    • Internal audits
    • Mock audits
  • SOP for inspections
  • Behavior during inspection-what to say, what not to say
  • Inspection process
  • 483 response process

These are the questions that this webinar will help a regulatory professional face and answer:

  • Does the FDA call in advance or just show up at my door?
  • Where do I let the inspector go?
  • Do I give them a tour?
  • What should I let them see?
  • Who should I let them talk to?
  • Are they ever going to leave?

This session is of immense value to those who are the frontline of facing an FDA inspection, such as:

  • Quality Auditors
  • Compliance Officers
  • Executive Management
  • Managers/Directors/Supervisors and Personnel related to:
    • Regulatory Compliance and Regulatory Affairs
    • Quality Management System
    • Quality Assurance
    • Quality Control
    • Product Development
    • Engineering
    • Manufacturing
    • Risk Management
  • Complaint Handling
  • Personnel new to the regulated industry
  • Training personnel
  • Document Control Personnel

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About the speaker:

During the more than 30 years of experience in he has had in Quality and Regulatory management, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

Jeff kasoff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies.

New Easy Ways to Learn Everything About Quality by DESIGN PROGRAM

Quality risk management and product process control are core components of QbD.

Quality by Design (QbD) is a Quality approach that relates to the ability of a pharma product to meet its quality requirements. In order to understand this concept, we need to first get a simple understanding of the meaning of quality in the context of the pharmaceutical industry. It means the ability of the pharmaceutical product to consistently deliver a pharma product that is free of contamination and meets the expectations of the consumer by offering the therapeutic value as defined in the product’s label. This has to be assured through a set of reproducible methods. The most common among these are in vivo and in-vitro methods.

QbD is a systematic approach to the process of ensuring quality in the pharmaceutical product. It seeks to meet predefined quality goals and objectives by employing the methods used in sound science. Quality risk management and product process control are core components of QbD. These are some of the goals that pharmaceutical QbD seeks to achieve:

  • Meaningful product quality specifications that are built on the foundation of clinical performance
  • Boosting the design, understanding, and control of the product and process with the aim of increasing process capability and reducing product variability and defects
  • Augmenting the efficiencies of product development and manufacturing
  • Bettering root cause analysis and post approval change management.

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QbD professional seek to achieve these goals through a twofold approach by which they:

  • Link the product quality to the desired clinical performance
  • Design a vigorous process of formulation and manufacture, which makes it possible for them to deliver the product with the desired product quality, consistently.

Now, new easy ways to learn everything about Quality by Design program

Applying the principles of a QbD approach can benefit the pharmaceutical companies immensely. By implementing these principles, they can bring about a measurable improvement in their manufacturing efficiency and can promote innovation. Yet, implementing these principles into the pharmaceutical development culture can be challenging for an organization, since QbD involves a complex set of interactions, technologies and systems that are not easy to grasp.

All these seemingly complex concepts need not befuddle you. Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic of new easy ways to learn everything about Quality by Design program. Compliance4All brings the highly experienced Quality professional, Steven Laurenz, as speaker of this valuable, hour-long session.

Please visit https://t2m.io/ffxwM3Ha to enroll for this highly meaningful learning on how to initiate and maintain a healthy QbD program that satisfies the requirement set out by the regulations in this field.

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The core of this training session is the understanding Steven will give of all the aspects of QbD, such as what it means, what benefits your organization can gain by applying a QbD approach, and what tools can be employed to implement a sound QbD approach. He will offer key steps for achieving this.

Core topics concerning QbD, such as the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy will be covered. The aim of offering an understanding of these topics is to help bridge the gap between understanding the principles and applying them practically.

This session is of immense use to those who are involved in the QbD process, and these include Process Owners, Quality Auditors, Quality Engineers, Quality Professionals, Production Engineers, Production Supervisors, Senior Quality Managers, Regulatory Professionals, Manufacturing Engineers, Compliance Professionals, Development Professionals, and Senior Development Managers.

At this webinar, Steven will cover the following areas:

  • Using Models
  • Risk Assessment
  • Control Strategy
  • Design of Experiments
  • FMEA and Control Plan
  • Developing a Design Space
  • Target Operational Profile
  • Process Analytical Technology (PAT)
  • Quality Target Product Profile (QTPP).

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About the speaker: Steven Laurenz brings a quarter of a century of experience in technical leadership, which has included areas such as product development, process development, technology transfer, and process optimization.

Steven is skilled in taking new products from early laboratory stage to successful manufacturing launch and is an expert in integrating Quality by Design and risk management into product development.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4070262/

https://learnaboutgmp.com/good-validation-practices/pharmaceutical-quality-by-design-qbd-an-introduction-process-development-and-applications/