In this Laboratory Investigation training learn what constitutes an OOS observation, what are the guidance's process & Steps to be taken in the laboratory in the event of an OOS observation.
Why Should You Attend:
Inadequate procedures for laboratory Out-of-specification (OOS) investigations remain high on the list of FDA observations. The FDA has issued a guidance on the topic, OOS procedures and investigations are still a topic of FDA Investigator review and findings. An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion.
There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this webinar we will discuss the investigation that goes on within the laboratory. Although the focus will be on the FDA Guidance, the discussion will include suggestions for a process that will meet the FDA expectations.
Areas Covered in the Seminar:

• Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other).
• US.
  • 21CFR211.160
  • FDA Guidance to the Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
• ICH.
  • Q7; 11.1
• Canada.
  • C.02.015

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Understanding of Laboratory control system as mentioned in System Based Inspection Guidances and how to use Laboratory control system to evaluate your laboratory.
Why Should You Attend:
Recent FDA 483 Inspection Reports and Warning Letters include many observations that demonstrate that there is a focus on compliance in the laboratory. FDA Investigators evaluate compliance to the CGMPs based on inspectional guidance outlined in two Compliance Policy Guides that provide the basis for system based inspections. One of the six systems defined in these inspectional guidances is the Laboratory Control System. The Laboratory Control System, as defined in these guidances establish the current FDA interpretation of programs that should be in place.
In this webinar we will discuss the Laboratory Control System, as identified in the System Based Inspection guidances. Discussion will be based on the five components of any system: Men, Materials, Machines, Methods, and Measurements, and how the inspectional guidance relates to each of these components.
Areas Covered in the Seminar:

• Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other).
• US- 21CFR211.160 , CPGM 7356.002 , CPGM 7345.848.
• Why the FDA uses a Systems approach to inspections.
• The six systems.
• The Laboratory Control System.
• Procedures, Records and Practices – The basics for all programs.
• Laboratory Control System Components.
• Using the Laboratory Control System to evaluate your laboratory.

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Understand as a HR personnel or a supervisor, how you can blend the differences of multiple generations working in a team and stay within legal compliance.
Why Should You Attend:

“When differences are encouraged, productivity & creativity increase.”
For the first time in the world of work, we have a new situation to deal with: four generations working side by side. Each generation has its own unique work style & key motivators. How can managers get these generations to work well together? In this program, Judi Clements shows you how to identify & lead the diverse individuals & teams in your organization. Through a series of interesting case studies, discussions, & research, you'll experience the difference between the way the generations think & work, and you'll learn how to make these differences blend, not collide, while staying within legal compliance.
Areas Covered in the Seminar:

• Distinguish between “stereotypes” & “generalizations”.
• Utilize generalizations to understand the generation mix.
• Distinguish between 4-generations in the workplace.
• Pinpoint historical & cultural influences that have shaped each generation's traits.
• Embrace the principle of “Generational Tolerance”.
• Identify each generation's workstyle, values, & motivators.
• Pinpoint key areas of generational differences.
• Describe how these areas account for differences on the job.
• Distinguish between how the generations want and need to be managed.
• Master 8-Intergenerational “Management Best Practices”.

This program helps managers master the art and science of performance documentation. Learn how to write behavioral documentation that protects your organization while promoting better performance from employees.
Why Should You Attend :

In our litigious society, it has become more & more important for supervisors to know how to document & discipline employees to avoid law suits and manage employee performance effectively. In this program, Judi gives managers a “crash course” in safe, legal, & effective disciplinary practices & documentation. You'll learn how to separate poor performance from poor attitude, counsel employees, & write Performance Improvement Plans. You'll learn how to keep a legal Performance Log to document both good & substandard performance. You'll learn how to implement your organization's disciplinary policy with confidence & accuracy.
Areas Covered in the seminar :

• Avoid the negative consequences of inadequate documentation & discipline.
• Utilize the range of disciplinary options.
• Respond quickly and appropriately to common disciplinary infractions.
• Keep a legal Performance Log.
• Counsel poor performers to encourage performance improvement.
• Distinguish between subjective and objective documentation.
• Work with employees to develop Performance Improvement Plans.

Note: Use this Promo Code(101299) to avail Discount of 10% on LIVE Purchase.

In this Food Recall training learn how to create a crisis response plan, data gathering, investigation phase specifics and how to communicate under different scenarios.
Why Should You Attend :
Reacting is the norm but anticipating and preparing are what's needed. Creating a robust process that will protect both the consumer and the company's reputation requires careful planning and the active involvement of each department. Another crucial element is communication, with the public as well as customers and shareholders. The risk posed by the product is one important element but anticipating the consumer's reaction is key. Whether they respond with disinterest to a serious hazard versus outrage requires a different communication strategy. As well, the messages sent at the outset of the recall will be different than when the regulator gets involved and different again as the recall reaches a conclusion.
The course will describe how to create the most comprehensive Recall Plan (or Crisis Response Plan).Once the process has been documented we will review the Data Gathering / Investigation phase specifically and give examples of microbiological studies (e.g. Listeria monocytogenes) important issues to be remembered. We will discuss what are the best practices of an effective crisis communication. We will discuss the roles and approaches under different crisis scenarios.
Areas Covered in the Seminar :

• Why should we have a Crisis Response Plan.
• How to create a flow diagram of the steps in a product recall.
• Develop list of team members' roles and responsibilities at each step.
• Understand product recovery vs product recall and its classification.
• Example of the recent product recall and its trickledown effect.
• Example of investigation process of a Listeria outbreak.
• Review the best practice for effective Crisis Communication.
• Outline the responses / approaches based on a variety of crisis scenarios.
• Questions and discussion: What do you see your role to be and the others in your company and add suggestions.

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Get detailed understanding of how to perform risk assessment as part of 10 step risk based approach to CSV.
Why Should You Attend:
Learn how to perform risk assessment as part of the 10-step risk-based approach to computer system validation. Minimize project time using fill-in-the-blank templates. Ensure compliance with QA, FDA, and clients. What makes this session unique are the real life examples that make application of the techniques understandable in the context of any validation project.
Areas Covered in the Seminar :

• How to use the risk-based approach to reduce validation time and lower costs.
• Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
• Reduce testing by writing test cases that trace to elements of risk management.
• Avoid 483s and Warning Letters.
• Interactive real life examples.
• How to identify risk and establish mitigations.
• Determine risk in a process to reduce the testing effort.

Note: Use this Promo Code(101902) to avail Discount of 10% on LIVE Purchase.

Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.
Why Should You Attend:
This session explores proven techniques that reduce validation project time, often to one-third. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based validation approach is detailed so that the specific documents for a validation project are understood. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This often results in a savings of two-thirds the cost. Additionally, this course will help companies increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement.
Areas Covered in the Seminar :

• Learn which documents the FDA expects to audit.
• Proven techniques that reduce software costs and implementation times.
• Increase corporate productivity and individual workforce member productivity.
• Efficiently create validation documentation.
• Decrease resource requirements.
• Make documentation more manageable and understandable.
• Avoid 483s and Warning Letters.
• How to implement a computer system to gain maximum productivity.
• Use resources effectively to perform effective validation while avoiding doing too much.
• How to link requirements, specifications, risk management, and testing.
• Document a computer system validation project using easy to understand fill-in-the-blank templates.
• Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.
Description:
Originally created July 12, 1993 and mandatory since June 14, 1998, the Directive requires that companies wishing to sell medical devices within the EU must meet the requirements under the directive. The regulations under this mandate can vary from member country to member country concerning translation of key documents to other regulatory laws specific to that region. These additions supplement the set of harmonized standards put in place by the European Commission. These harmonized standards serve to free the flow of goods from one market to another within the EU Medical Device industry. Today, all medical devices sold in the EU must have the CE marking affixed to demonstrate compliance to this directive. If your device falls within the scope of the Medical Devices Directive, then you must meet the essential requirements of that law.
Areas Covered in the seminar :

• Identify the steps required to obtain CE Mark…and meeting compliance expectations.
• Understand how to apply and use the Conformity Assessment Procedure.
• How to classify your medical device correctly?
• Learn how to use the Technical File correctly.
• How to apply the Declaration of Conformity and why this is critical for success?
• How ISO 13485 fits in with this process as a device company?
• Learn and understand the expectations for the Essential Requirements and the Certification Process
• How is the Authorized Representative involved and why…and the ramifications of not meeting the requirements for CE Mark and 93/42/EEC for your company.

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This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
Description
Attend this webinar to know the what happens in a recall and what are the strategies and operational procedures in a recall.Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.
Areas Covered in the seminar :

• Create and use a recall operational procedure and what should it contain.
• Understand what are effectiveness checks.
• What happens in a medical device recall.
• Learn why a recall is either a correction or a removal depending on where the action takes place.
• Understand why is required for the recall strategy as expected by FDA.
• Medical device recall authority and guidance.
• Depth of recall and using a viable, sustainable and effective strategy.
• Understand why the documentation and paper trail are so critical and termination of a recall.

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This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.
Description Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.
Areas Covered in the seminar :

• QSR and ISO 13485 requirements for document control
• Description of typical document control system in use
• Streamlined document control process
• Paper-free document review
• Immediate document distribution

Note: Use this Promo Code(102357) to avail Discount of 10% on LIVE Purchase.