Facts about deviation investigations everyone should know

Having a procedure on Deviation Investigations isn’t enough. it’s the content and conclusions of the investigations themselves that really count.

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Focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.

One of the foremost common authority 483 and Warning Letter citations continues to be inadequate investigations. The authority uses the investigation reports and investigation trends to spot potential quality issues altogether areas of the corporate. Ultimately, inadequate investigations will result in 483 citations, Warning Letters, unharness of sub-standard product, or product recall. what is more, pricey and long system rectification is also needed.

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Having a procedure on Deviation Investigations isn’t enough. it’s the content and conclusions of the investigations themselves that really count. Doing a correct root cause analysis, gathering proof and guaranteeing a property corrective action is vital to a correct deviation investigation.

This Session can facilitate attendees perceive the elemental investigation steps and ability sets. Key focus are placed on identification and initial news of deviations, fact/evidence gathering, and incoming at the right root cause and CAPA. The importance of investigation coming up with, vital thinking skills and effective preventative action plans will be mentioned.

Who will be benefit:

  • Deviation Investigators
  • Reviewers and Approvers of Deviation Investigations
  • QA Staff and Management
  • Regulatory Affairs Staff and Management
  • QC staff and Management
  • Compliance Auditors

About the Instructor:

Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.

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Implementing a Practical Technology Transfer Process

Execution of that move is mind boggling including the connections of numerous controls over an association.

The ideas related with actualizing a painstakingly characterized specialized and business administration programs alongside plainly characterized R&D to site move ventures for fruitful usage.

It will cover the ideas related with moving the logical innovation expected to make the item, procedures to guarantee the getting fabricating office is prepared for the item and devices and formats to help catch the information.

  • Characterize innovation move
  • Distinguish components of the business procedure structure for overseeing innovation moves
  • Distinguish New Product move process
  • Clarify advantages of innovation move
  • Decide components of an effective innovation move

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Fruitful exchange of pharmaceutical items and their procedures is basic to the effective dispatch. Its prosperity guarantees that results of the most astounding quality are conveyed to the patients alongside gathering the business requests of the organization. Anyway execution of that move is mind boggling including the connections of numerous controls over an association.

  • The importance of technology transfer

Who will get the benefit by this:

  • Senior quality Managers
  • Quality Professionals
  • Regulatory Professionals
  • Compliance Professionals
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors
  • Development Professionals
  • Senior Development Managers

About the instructor:

Steven Laurenz Chemical Engineering M.S. – Michigan State University Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization. Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortium. Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistic.

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Implementing a GxP Quality Management System-Outrageous Ideas For Your GxP Quality Management System

An unsuccessfully implemented QMS not only dwindles the organization’s resources; it could take it further away from its Quality goals.

In a scenario of competitive markets, informed customers and rapidly changing business environments, organizations are realizing that Quality and Quality Management Systems (QMS) are an indispensable tool by which they can stay ahead. This is all the more pronounced when it comes to pharmaceutical companies, since their products are delivered directly to the human body.

The benefits of a clear and effective QMS are varied. They are proven, documented and quantifiable. The most prominent benefits a successful QMS brings about are the maximization of customer satisfaction, a lowering of costs, and an increase in agility. It fortifies an organization’s quality policy, objectives and core values at every level, and integrates iterative process improvement mechanism into it. This integration engenders alignment with FDA regulations and allows the organization to optimize its product and support processes.

QMS

A GxP QMS is a process whose implementation requires the competency, commitment, coordination and confidence of all production and support staff and management. Understanding some fundamental concepts, benefits and barriers will increase the likelihood of effective GxP QMS development and deployment, compliance with quality drivers and increased customer satisfaction.

A thorough understanding of these concepts will be imparted at a valuable webinar that Compliance4All, a leading provider of professional training, is organizing on July 26. William D. Fox, a quality management professional, will be the expert at this 90-minute session, which will impart Senior Managers, Managers & Supervisors, Process Owners, Departmental Heads, QA, QC and Continuous Improvement Managers & Staff, Quality Consultants, Regulatory and Compliance Managers, and Change Control/Documentation Staff with tremendous insights into all aspects of a GxP QMS.

Please visit to enroll for this session

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For an organization to implement a QMS, all its production and support staff and management need to have competency, commitment, coordination and confidence of everyone involved in it. The deeper their grasp of a few fundamental QMS design and implementation concepts, benefits and barriers; the greater the chances of an effective deployment.

Quality Management Systems vary across and within industries and organizations. Some of the parameters that go into making each organization’s QMS unique are Quality drivers such as industry standards, regulations and best practices. Each company can use these to create a tailored design and implementation strategy that implements the organization’s specific goals, processes and customers.

QMS is such a core part of an organization’s Quality Policy that it affects every aspect of the performance. An unsuccessfully implemented QMS not only dwindles the organization’s resources; it could take it further away from its Quality goals.

At this webinar, the participants will gain solid understanding of all these aspects of a QMS, which will reap for them all the benefits it brings. William will cover the following areas at this session:

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Things You Need To Know About Cyber Security Incident Response Team Today

How to set up a foolproof and robust CSIRT that will help avert a cyberattack.

That cybersecurity is the most critical component for an organization is beyond debate. This goes without saying because attacks to any organization’s computer systems can happen at simply any time, at any location, and at any time of the day. This calls for them to be completely alert on a 24X7X365 basis.

A Cyber Security Incident Response Team (CSIRT) is indispensable for any organization, private or government, to ensure that valuable data is not breached. A system that is ready for cyberattacks 24X7 should consist primarily of a mechanism for both reporting incidents and disseminating incident-related information correctly.

A valuable webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show how to set up a foolproof and robust CSIRT that will help avert a cyberattack.

At this webinar, which is being organized on July 23 and is of sixty minutes’ duration, Michael Redmond, Consultant, Speaker and Author, will be the speaker.

Please register for this webinar by visiting

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Most companies do set up a CSIRT, but one major issue with most of them is that the teams are not adequately trained to handle and test all aspects of the security issues. Both testing and training are necessary to create awareness among the teams, which will help them to respond to an attack or a potential one better. Both reporting incidents and disseminating incident-related information correctly is a must.

Personnel connected with cybersecurity, such as CISO, CSIO, CEO, Risk Managers and Auditors will gain enormous learning from this session, which will cover the following areas:

  • How often to test
  • Types of testing
  • Who should be involved
  • Scenario Development
  • Organizational process

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 selected to speak on Cyber Security Incident Response and SIEM at various conferences.

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The Next 7 Things To Immediately Do About Excel Data Visualization

Data visualization is the representation of numerical data in a visual format so that your audience can quickly and easily understand it and gain insight from it.

In this session, participants will learn how to visually represent your data using both traditional charts (bar charts, line charts etc.) as well as how to do the same using some of Excel’s non-charting tools.

Until a few years ago it was enough to take a set of numbers and create a bar chart or pie chart. Although in the right situation these traditional charts are still appropriate, things have moved on and we’re constantly hearing words like Data Visualization and Infographic.

It’s time to get your Excel-related business and communication skills up to date and learn how to use it to present data in the modern world. Data visualization is the representation of numerical data in a visual format so that your audience can quickly and easily understand it and gain insight from it.

Areas covered by the instructor

  • Charting 101 – create a basic chart
  • From drab to fab – enhance and customize a basic chart
  • Combination charts – line and bar in a single chart
  • Dynamic charts – automate adding new data to a chart
  • Creating in-cell Sparkline charts
  • Creating infographics with Excel
  • Using Conditional Formatting to present data visually
  • 3D Map – presenting geographic data in a visual way
  • An introduction to the Power View add-in

Important Learning Objectives you have to learn :

  • Learn how to select the most appropriate chart to convey your message
  • Learn how to create a chart from a set of data and change its appearance
  • Learn how to create Sparkline charts (really useful in dashboards)
  • Learn how to create infographic-style charts
  • Learn how to represent data in a visual way without using the charting tools

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Preparing for OSHA Voluntary Protection Program (VPP): Brick by Brick

OSHA VPP program in an organization is bound to find the nuances of this program complex and overwhelming.

The Occupational Safety and Health Administration (OSHA)’s Voluntary Protection Program (VPP) is the highest award in Health and Safety Excellence that OSHA presents to an organization.

Candidates are selected on the basis of these five factors:

  • Management commitment
  • Employee involvement
  • Workplace Analysis
  • Hazard Prevention and Control

Any Environmental Health and Safety (EHS) professional, new or experienced, assigned the responsibility of overseeing the OSHA VPP program in an organization is bound to find the nuances of this program complex and overwhelming.

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Such organizations now have a solution to this issue. A webinar from Compliance4All, a leading provider of professional training for the areas of regulatory compliance, which is being organized on June 25, will offer thorough and complete insights into the OSHA VPP program.

At this webinar, Deidre Tate, a Certified John Maxwell Trainer, Speaker and Business Coach, will be the speaker. Please visit to register for this webinar

New National Bioengineered Food Disclosure Act (GMO Labeling)

The NBFDSA requires all foods containing bioengineered ingredients (BE) to be disclosed. Such foods must also meet recordkeeping and compliance requirements.

The United States Department of Agriculture (USDA) issued its long-awaited, new food labeling regulation known as the National Bioengineered Food Disclosure Standards Act (NBFDSA). This issuance has come up after the regulation was dogged in controversy for many years. This new rule, which was highly anticipated by industry, is expected to offer clarity on several long-standing GMO questions relating to the financial and risk impact to businesses, and help consumers make well-informed, educated, and science based food choices.

Being a federal standard, the NBFDSA offers a leveling the playing field for industry and aids consumers who are often confused on GMO or non-GMO product labels.

Want to know all about this regulation? A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will explain everything that the industry needs to know on launching the NBFDSA.

Gina Reo, President, Quality Assurance Strategies, LLC, will be the expert at this session. Please visit to enroll for this valuable session.

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The NBFDSA requires all foods containing bioengineered ingredients (BE) to be disclosed. Such foods must also meet recordkeeping and compliance requirements. At this session, Gina will explain the definitions of foods subject to the ruling, exclusions, responsible parties, mandatory disclosure options and recordkeeping and implementation dates, and clear confusions relating to them.

She will cover the following areas at this session:

  • Background on US GMO (Genetically Modified Organism) Labeling
  • Basics of the National Bioengineered Food Disclosure Rule (National Bioengineered Food Disclosure Standards Act)
  • Ingredients Subject to Disclosure
  • Labeling Disclosure
  • GMO Disclosure Symbols
  • Thresholds and Exemptions
  • Compliance Timelines for Implementation
  • Insights & Success Takeaways

A large swathe of professionals who work in these areas are expected to derive wholesome benefit from this learning session. Quality Control/Assurance and Food Safety Professionals, Supervisors, Leads, Managers, Operations Managers/Supervisors, Sanitation Managers, Supervisors or Leads, Corporate Quality Managers, Operations Personnel, Senior Management, Plant Management Personnel, Third Parties Developing HACCP Plans, Auditors and those with Food Safety Inspection Roles, Validation Specialists, Consultants, Quality system Auditors, and PCQI’s are among them.

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