Get the Record Straight: OSHA's New Injury Recordkeeping E-Submission Rule

‘Joe Keenan’ the expert speaker who is presenting a webinar on OSHA’s NewInjury Record keeping Data Electronic Submission Rule, will give you a clear understanding of your responsibility for the new electronic submittal process and ramifications to the employer on May 10, 2017 at 10:00 AM PDT, 01:00 PM EDT | Duration: 120 Minutes.

The impact of OSHA record keeping regulation changes on occupational injury and illness:

The Survey of Occupational Injuries and Illnesses (SOII), based on Occupational Safety and Health Administration (OSHA) logs, indicate that the number of occupational injuries and illnesses in the US has steadily declined by 35.8% between 1992 and 2003. However, major changes to the OSHA record keeping standard occurred in 1995 and 2001.

Adverse Impact of Publishing Data

OSHA intends for the data to harm employers by:

• Thwarting contracting openings with clients

• Providing ammunition to your rivals and composed work for arranging efforts or at the dealing table

• Scaring off present and planned representatives;

• Eliminating access to business loans and

• Negatively affecting protection scope and rates

Internal Injury Reporting Policies

Employers may be cited for implementing reporting policies that have perceived retaliatory effect for reporting workplace injuries:

• Discipline for “late” injury reporting
• Discipline for violating vague rules (“work safely” or “maintain situational awareness”), especially if only after injuries

Reasonable reporting policy may require employees to report injury “as soon as practicable” after realizing they have a reportable injury

• Not reasonable to discipline employee for failing to report before they realize they are injured or while incapacitated

Discipline for violating safety rule only reasonable if consistent

Click on this link for more info or Register now for this brainstorming session by Joe Keenan- OSHA's New Injury Record keeping E-Submission Rule

Bridging Multiple Generations in the Workplace

How to Establish a Strong Workplace with 5 Generations of Employees

Instructed By: Mary Gormandy White on 09 May 2017  

Time: 11:30 AM PDT, 02:30 PM EDT | Duration: 60 Minutes

Description:

It's the first run through in history that workforce incorporates laborers from 5 unique eras. While this can be commended for its appreciated differing qualities, this can posture challenges for both connecting with workers and also teaming up with different partners.

Four, and potentially five, eras work next to each other in today's working environments: Veterans (born 1930–1945), Baby Boomers (1946–1964), Generation X (1965–1976), Generation Y (1977-1990) and Millennial (born since 1991). Albeit every individual is a person with his/her own particular identity, shared encounters formed the eras and impacted their work styles. Perceiving the qualities and estimations of every one advances regard for diversity and fosters cohesiveness inside the working environment.

Objectives of the Presentation

• · Identify qualities and pick up a superior comprehension of the five eras

• · Improve interchanges and collaboration

• · Accept moral duty in cooperating

• · Provide tips and proposals for defeating generational contrasts

To better connect with and team up with the diverse eras at work, here are general depictions and desires from every generation/era:

Traditionalists (pre-1946)

The most established (and smartest) era of today's workforce, Traditionalists are the ideal tutors for new employees, because of their encounters and abundance of information. A lot of this era is dedicated and exceptionally faithful to their organization. Traditionalists work to accomplish "an occupation well done."

Baby Boomers (1946 – 1964)

This gathering is known for judging and assessing others in light of an obsolete metric. They connect work and status with self-esteem. Much the same as Traditionalists, regard originates from residency and status. With solid hard working attitude, up close and personal relational abilities, and work involvement, experts of this era can be fantastic good examples for more youthful eras.

Generation X (1965 – 1976)

This gathering is known for being doubtful and demanding that everybody pay their duty precisely as they doing it. The first to challenge business as usual, this era is apart from the general properties seen from past eras. They have an incredible compatibility with administration; however don't concur with the workplace pecking order strategy. Regard is earned through execution, not understanding or status. Gen Xers anticipate that their organization will be beneficent, Eco-accommodating, and offer charitable effort amid available time. They value preparing openings and appreciate financial prizes, in light of their individual execution. Gen Xers are exceptionally autonomous, yet cooperate with other people and even urge others to think freely.

Millennials or Generation Y (1977 – 1997)

Millennials otherwise called "Gen Y," this gathering is condemned for poor relational abilities, a feeling of privilege and unremarkable relationship building abilities. Millennials are the quickest developing and most various populaces in the workforce. Millennials will probably acknowledge an occupation that fits their way of life more than one that pays more. Their work/life adjust is focused on the possibility that business is "an unfortunate obligation." Millennials are exceptionally hopeful and very vigorous, which is awesome to empower different generations.

Generation Z (after 1997)

The best in class era of specialists, Generation Z is gradually venturing in as the fifth era in today's workforce. While it is still too early to make speculations about the hard working attitude and desires of this era, Generation Z might be more not quite the same as Millennials than we understand. They both originated from a period where innovation and online networking was in the photo. In any case, Gen Z took a hold innovation at a significantly more youthful age. Hence, Gen Z might be more innovation proficient than whatever other era. While both Millennials and Gen Zers share individual data on the web, Gen Z has set online networking at the focal point of their correspondence channels, instead of eye to eye correspondence. Gen Zers will acknowledge more virtual work joint efforts than Millennials. While Millennials have shown adoration for ambiguity and decision in work style and work environment, Gen Zers will require more structure and consistency in the working environment.

Register yourself for this brainstorming session Now- BridgingMultiple Generations in the Workplace

Statistical Process Control with Process Capability Analysis

Statistical Process Control

Course "Statistical Process Control with Process Capability Analysis" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Description:

Statistical Process Control is an analytical decision making tool which allows you to see when a process is working correctly and when it is not. Variation is present in any process, deciding when the variation is natural and when it needs correction is the key to quality control.

Statistical Process Control (SPC) is a two-day "hands on" session by Daniel O'Leary - President, Ombu Enterprises, LLC , which will provide an understanding of variation and the associated statistical methods to effectively apply SPC to any process. This course is targeted at practitioners; the concepts and tools are presented during this course are particularly relevant to quality, manufacturing, design, strategic sourcing and operations. During this workshop, participants will learn how to analyze available data and describe a process in statistical terms; establishing an expected range of output performance, based on quantified patterns of variation, in order to both identify when fundamental process changes occur and execute effective process improvements. Participants will learn the SPC tools and techniques applied to identify control limits, understand expected process variation and interpret "out of control" signals in order to proactively take corrective action. Participants will also learn how data derived from SPC can be used to define process capability and how this information can be applied in product design.

Process capability analysis is used to adjust the process until virtually all of the product output meets the specifications. Once the process is operating in control, capability analysis attempts to answer the question: Is the output meeting specifications, or is the process capable? If it is not, can the process be adjusted to make it capable?

What is Process Capability?

1. Process capability is the long term execution level of the procedure after it has been brought under statistical control. In other words, process capability is the range over which the characteristic variety of the procedure occurs as dictated by the arrangement of basic causes.

2. Process capability is likewise the capacity of the blend of individuals, machine, techniques, material, and estimations to deliver an item that will reliably meet the outline prerequisites or client desire.

The capability analysis is carried out in the following steps:

·        Selects the process to be analysed and collection of data;

·        Identify specific limits according to which capability analysis will be evaluated;

·        Verify the process is under statistical control;

·        Analyse data distribution;

·        Estimate capability indices.

Measures of Process Capability Indices:

Cp, Cpl, Cpu, and Cpk are the four most normal and coordinated tried measures of process capability.

• Process capability indices measure how much your procedure produces yield that meets the client's detail.

• Process capability indices can be utilized successfully to abridge process capability data in an advantageous unit less framework.

• Cp and Cpk are quantitative expressions that represent the inconstancy of your procedure (its characteristic limits) with respect to its particular breaking points (client necessities).

Register for the seminar:

Statistical Process Control with Process Capability Analysis

Production and Process Control: Building a Robust System

Production Process Control

Two days workshop on:

Date:           31 August 2017 & 01 September 2017

Location:    Boston, MA

During this interactive 2-day workshop, expert instructor, Dan O'Leary, Principal of Ombu Enterprises, will teach you the fundamentals of production and process controls. He will guide you through the fine points using the FDA's own inspection documents coupled with extensive use of Warning Letters to illustrate the issues device manufacturer's face.

Mr. O'Leary will begin by detailing the development of the Quality Management System (QMS), laying the regulatory foundation. He will then teach you how to set up your production system for the life cycle from design transfer to product release to Risk Management production information collection.

Areas Covered

Over the course of two days, instructor will address the following topics:

•          The role of design output and design transfer

•          Developing quality plans

•          Establishing, monitoring, and controlling process parameters

•          Production equipment including installation, maintenance & effectiveness metrics

•          Validating production software

•          Controlling and calibrating measuring equipment including trace-ability

•          Evaluating and selecting external calibration laboratories

•          Production changes and when they are also design changes

•          Determining the process that require validation

•          Process validation as a statistical issue

•          Acceptance activities including sampling plans

•          Nonconforming product and associated corrective action

•          Risk management (ISO 14971) and production

Register yourself for this brainstorming session now and get special group discounts on registration- Production and Process Control: Building a Robust System

Statistical Techniques for Medical Device Manufacturers

Statistical Techniques for Medical Device Manufacturers

By - Dan O'Leary, President at Ombu Enterprises, LLC on 30 November 2017 & 01 December 2017

Location: San Francisco, CA  

The seminar starts with an understanding of the regulations through a variety of sources. Ex: QSR, ISO 13485:2003, and ISO 13485:2016. Each application of statistical techniques starts with the regulatory requirements and is augmented by the preamble, where FDA addressed the comments it received on the proposed QSR. FDA published an extensive manual to help manufacturers implement the regulations. The seminar analyzes the objectives in the Quality System Inspection Technique (QSIT), the Medical Device Single Audit Program (MDSAP) and then turns to Warning Letters to help understand the methods of regulators.

In addition to statistical methodology, as part of CA & PA information, is required to identity recurring quality problems based on device manufacturers analysis. A similar requirement applies to servicing analysis. The requirement for process validation with a "high degree of assurance" is a requirement for process capability and product characteristics, i.e., a statistical technique.

Upon course completion participants will be able to:

•         Learn the sections of FDA QSR that require statistical techniques.

•         Understand how to apply the FDA tools to develop a clear understanding of the requirements.

·*     Regulation

·*     Preamble

·*     Small Entity Compliance Guide

·*     QSIT

·*     Warning Letters

•       Understand the set of statistical techniques in ISO/TR 10017

•        Learn how to implement and apply the ISO/TR 10017 statistical techniques.

Register yourself for this brainstorming session Now- Statistical Techniques for Medical DeviceManufacturers

Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, Medical Device Reporting/ eMDR and Recalls and their compliance with UDI's

Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: The FDA keeps on enhancing its devices and systems in its command to secure the general well being. Post-showcase exercises, including electronic revealing, UDI (Unique Device Identifier) prerequisites and Emerging Signals Guidance are all part of the development in desires for Quality Systems for Medical Device organizations. Execution of necessities for electronic therapeutic gadget detailing was critical to lessening workload, enhancing examination, and expanding speed in identifying and revealing issues. UDI (Unique Device Identifier) gives away to all the more effortlessly and precisely distinguishing, breaking down, and drifting items and quality issues. What's more, draft direction on "Rising Signals" is the following stride in offering quality worries to the general population to forestall potential damage. These progressions mirror the advancement in intuition and quality framework desires for medicinal gadgets. Medicinal gadget organizations need to comprehend the changing administrative atmosphere and set up their procedure for what's to come. This online class will help you comprehend the effect of the progressions and help you plan.

Complaint Handling and Medical Device Reporting are viewed as critical procedures by the FDA in keeping up the general population well-being. Since they are so critical they were as often as possible reviewed regions by the FDA. All the more essentially, protestations can likewise be an early cautioning of issues with your items and client issues. It is imperative to have proficient and powerful procedures for overseeing, breaking down, drifting, and detailing item issues. Disappointment examinations and CAPA are essential to comprehension and settling these quality issues. What's more, redresses and expulsions are once in a while essential. This online class will cover the fundamentals of these vital quality framework necessities.

This preparation program will talk about the rudiments of the Medical Device Complaint Handling Regulations and audit the procedure for getting ready to satisfactorily set up and keep up the methodology for getting, checking on, and assessing protests. It clarifies a legitimate treatment of objections. What is reportable or non-reportable to the FDA for an item protestation, taking care of and documentation, how and when to record Medical Device Reports (MDR), and enter calculates actualizing and keeping up consistency under 21 CFR 803 directions and genuine encounters of the FDA.

Areas Covered in the Seminar

• Complaint Handling and FDA Expectations
• Medical Device Reporting Procedures (
• MDR)
• MDR FDA Perspective
• User Error Malfunction
• Recalls: Definitions and Legal Authority
• Being Recall Ready -Proactive Steps to Avoid Crisis
• Evaluating Risk and Health Hazard Evaluation (HHE)
• Corrective and Preventive Action System
• Elements of Correction and Removal Report
• Developing effective Strategies and Communicating with FDA
• Notification Letters and Press Releases
• Silent Recalls vs. Product Enhancements and Enforcement by FDA
• Product Retrieval Issues, Effectiveness Checks and Status Reports
• Termination of a Recall

REGISTER for the Seminar Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, Medical Device Reporting/ eMDR and Recalls and their compliance with UDI's

Quality Management Systems that Comply with ISO13485:2016

Course Description:

The Course "Quality Management Systems that Comply with ISO13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

ISO 13485:2016 indicates prerequisites for a quality administration framework where an association needs to exhibit its capacity to give medical devices and related administrations that reliably meet client and relevant administrative necessities. Such associations can be included in at least one phase of the life-cycle, including plan and advancement, creation, stockpiling and circulation, establishment, or overhauling of a restorative device and outline and improvement or arrangement of related exercises (e.g. specialized support).

Prerequisites of ISO 13485:2016 are relevant to associations paying little heed to their size and paying little mind to their sort with the exception of where expressly expressed. Wherever prerequisites are indicated as applying to restorative devices, the necessities apply similarly to related administrations as provided by the association. 

The procedures required by ISO 13485:2016 that are pertinent to the association, yet are not performed by the association, are the obligation of the association and are represented in the association's quality administration framework by checking, keeping up and controlling the procedures. 

On the off chance that appropriate administrative necessities allow prohibitions of plan and improvement controls, this can be utilized as a defense for their avoidance from the quality administration framework. These administrative prerequisites can give elective methodologies that are to be tended to in the quality administration framework. It is the obligation of the association to guarantee that cases of adjustment to ISO 13485:2016 mirror any rejection of plan and improvement controls.

For a long time, ahead of schedule in the life of ISO 9001 and ISO 13485, it took a ton of instruction with respect to ISO examiners to show organizations the contrast between Corrections (settling the issue) and Corrective Actions, fixing the underlying driver of the issue. Organizations have now taken in these definitions truly well. In any case, the Corrective Action and Preventive Action (CAPA) framework frequently do not cover rectification and control activities identified with CAPAs. Adjustments for item issues are generally being done under different bits of ISO 13485, for example, control of nonconforming item and client criticism and grievances. These regularly have the little visibility in the Corrective Action framework, and by and large, don't address at all containing or rectifying quality framework issues that are frequently a noteworthy part of a CAPA framework. So now ISO evaluators, or if nothing else ISO 13485 Notified Body reviewers, are expecting that organizations record and give prove that they are doing regulation as well as rectifications, totally and rapidly. 

Join Lena Cordie  in this interactive workshop to get detailed guidance on how to develop, implement and maintain strategies in order to achieve a specific goal. This session will include lectures, round table discussions and activities all aimed at understanding key strategies and identifying specific actions to effectively improve Quality Management System Compliance.