IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology.

This new philosophy has been difficult for test houses and compliance bodies to absorb and develop test strategies. Currently, the EU and Canada have announced May 31-June 1, 2012 as the date when the Second Edition will be withdrawn. Devices that will be released after that date must meet the requirements of the Third Edition. Manufacturers with products under development must start now to develop compliance strategies. The first step will be understanding the requirements of the new standard.

Areas Covered in the Session:
ISO 14971 compliance is a requirement of IEC 60601-1
The new standard uses risk management throughout
The new standard is less prescriptive in many areas
The new standard requires that all applicable collateral and particular standards must be used for compliance
Current activities leading to full implementation of the standard
Available documents to guide implementation of the Third Edition
Who Will Benefit:
Design Engineers
Quality Engineers and Managers
Compliance Engineers
Engineering Managers
Project Managers
Verification and Validation Engineers and Mangers

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

Description

Overview: Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.

Areas Covered in the Session

- FDA and ISO requirements for complaint handling

- Establishment of complaint handling program

- What constitutes a complaint

- ISO-specific implications of complaint handling

- The roles of investigation and corrective action in complaint handling

- Complaint trending and reporting

- Application of risk management to complaint handling program

Who will benefit: (Titles)

This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

· Regulatory Management

· QA Management

· Customer Service Personnel

· Sales Personnel

· Quality System Auditors

· Consultants

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

Why should you attend: Performing requires Hazard and Risk Analysis often poses a challenge for development teams. How detailed does the analysis have to be? What is the difference between hazard and harm, hazard and hazard cause, Hazard analysis and FMEA, etc.? How do we combine the risk rating when different mitigation measured are used simultaneously? This presentation will try to answer all these questions and provide a partial guidance on how to effectively perform a Hazard and Risk Analysis.

Areas Covered in the Session:
Structure of a Risk and Hazard Analysis document
Stakeholders and participants
How to conduct a hazard analysis meeting

Meeting ground rules
Hazard and Harm characteristics

Methods to identify potential hazards
Risk and Risk Rating methods
Risk mitigation strategies
Risk assessment and Residual Risk
Who Will Benefit:
Project Leaders
Design Engineers
Regulatory
Quality

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

Overview: This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan.

This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities. We will discuss both laboratory instruments and critical facility systems. We will provide templates for risk assessment and validation strategy. A case study will illustrate the time lines, cost savings and benefits of a risk-based validation master plan.

In installing equipment, how much validation is enough? How much is too much? Risk-Based Validation establishes rules for what is appropriate and is the FDA-preferred method for determining what qualification protocols are required. It is based on the intended use of the equipment and the impact it may have on regulated processes, safety and quality. This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan. It includes a specific real-life project involving over 100 separate pieces of equipment and utilities, and the regulatory inspector’s subsequent comments.

Areas Covered In the Session:

Risk-Based Equipment Validation
Equipment and Utility Qualification
Risk management Tools
Functional Risk Analysis
Risk Scoring
Risk Mitigation
Score-Based Validation
Project Outcomes

Who will benefit: This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and manufacturing services will also benefit.

End-users responsible for applications and systems
QA Managers and Personnel
Facility Managers and Personnel
Senior Quality, Regulatory and Operations Management
Regulatory Affairs staff
Quality System Auditors

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Overview: Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s and expanded as an international expectation for the industry with the publication of ICH Q2 in the mid 1990s.

Both USP <1225> and ICH Q2 classify test methods employed in the industry into types, based on the intended use and identify the characteristics that must be considered in the validation of each type of method.

In order to perform effective test method validations, the analyst must understand the importance of clearly identifying and understanding the intended use of the test method. With the understanding of the intended use, the analyst will categorize the test method into one of the types identified in the USP and ICH Q2. Based on the type of test method and using the guidance in the USP and ICH Q2 the analyst will identify the characteristics that must be considered for effective method validation.

For each characteristic, the USP and ICH Q2 recommend the experiments that the analyst should performed to demonstrate that the method performs as intended.

Why you should attend: The US FDA and other regulatory agencies are critically reviewing test method validations. Observations like: "Failure to establish accuracy, sensitivity, specificity, and reproducibility of test methods employed by your firm", which appear in Warning Letters and 483 observations demonstrate a complete lack of understanding of the regulatory expectations. Other observations that citing to the individual characteristics demonstrate a lack of appreciation for the contributions of the individual method characteristics on adequate method validations. In order to adequately validate test methods, firms must understand the basic terminology associated with test method validation. This webinar will provide an understanding of:

The types of test methods established by the USP and ICH Q2.
Assay
Identification
Testing for impurities – quantitative
Testing for impurities – limit
Performance
The characteristics of test methods as defined in the USP and ICH Q2.
Specificity
Accuracy
Precision
Linearity
Range
Limit of Accuracy
Limit of Detection
How the characteristics apply to the types of methods described in USP and ICH Q2.
The basics of how to experimentally evaluate the characteristics.

Areas Covered in the Session:

The requirement for test method validation
The intended use of the test method
Guidance documents covering test method validation
Types of test methods
Characteristics of test methods
Demonstrating the characteristics

Who will benefit: The following individuals or disciplines will benefit from attending this Webinar:

Quality Assurance personnel
Quality Control Managers
Quality Control Supervisors
Quality Control Analysts
Method development Managers
Method development Supervisors
Method Development Analysts

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

The new ISO Individual Case Safety Report (ICSR) standard is being finalized in 2011. A major revision of the ICH E2B guideline is progressing based on the new ICSR standard with an ICH step 2 consultation of the ICH E2B(R3) Implementation Guide expected by the end of June 2011. An overview of the proposed changes to the ICSR Final Draft International Standard (FDIS) and its implementation will be discussed, along with the expected changes to the ICSR reporting in the context of the new European pharmacovigilance legislation.

Join BioPharm Systems' Andrew Mitchell, EMEA safety and pharmacovigilance practice lead, for this one-hour presentation that will include:

- - Discussion of the upcoming ISO Individual Case Safety Report (ICSR) standard known as ICH E2B(R3)

- - Electronic reporting of ICSRs and EudraVigilance in the context of the new European pharmacovigilance legislation

- - Using Argus Safety to comply with the information and regulations above and how this affects your upgrade planning

Thursday, April 28, 2011 @

9:00 a.m. Pacific
10:00 a.m. Mountain
11:00 a.m. Central
12:00 p.m. Eastern
5:00 p.m. GMT

Why Should You Attend:

The recent financial crisis has proven that integrated Governance, Risk & Compliance (GRC) strategy and a broader context of GRC Management, both to mitigate risks, cost of non-compliance and also to revisit the business processes as well as to capture value generating business opportunities is essential. A revised and integrated GRC strategy and concepts also helps the board of directors and senior management to reengineer the business processes to bring about a change in how they view, mitigate and profit from GRC business issues.

However the focus on GRC activities shouldn’t obscure the bigger business picture that the board of directors is also responsible for. The role of the Board in developing various strategies like key strategic drivers, Purpose/mission vision, values and ethical considerations will be presented. IT, Analysis, Strategic Influences, Environmental forces, IT tools for board analysis, Contribution of human resources, and leadership, managing uncertain and ambiguous times.

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.

This Integrated Risk Management Approach training in ISO 14971 will discuss how to incorporate risk management as per ISO 14971 in all phases of medical device development and what all documentation to be gathered to support the decisions made as a part of risk management process.

Areas Covered in the Seminar:

How are risk management activities integrated throughout the development process.
The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Process.
How to control and verify risk mitigations.
How to perform a Risk Benefit Analysis on ALARP and INTOLARABLE Hazards.
The importance of maintaing Risk Management documents in the Post Production era.
What information to include in the Risk Management Plan and Report for better auditability.

Why Should You Attend:
Background screening with set standards provides a basis or foundation for success of your organization. Employment assessments, based on behavioral consistency, identify applicants with the particular skills and abilities needed to fill specific jobs. Criminal and civil background checks combine essential due diligence with reduction of potential liability. With high unemployment, basic human nature is that applicants present themselves in a manner that can cross the line from fact to fictional embellishment. It is imperative for employers to be skillful in detecting non-factual elements in applicant backgrounds.

Attend this webinar to understand how to manage risk in hiring, how to do background checks/screening, employee assessment. What are the factors you need to look while hiring or doing assessment of a candidate so that you are hiring a right candidate which does not cost your business dearly.

 This Integrated Risk Management Approach training in ISO 14971 will discuss how to incorporate risk management as per ISO 14971 in all phases of medical device development and what all documentation to be gathered to support the decisions made as a part of risk management process.
 
Areas Covered in the Seminar:

• How are risk management activities integrated throughout the development process.
• The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Process.
• How to control and verify risk mitigations.
• How to perform a Risk Benefit Analysis on ALARP and INTOLARABLE Hazards.
• The importance of maintaing Risk Management documents in the Post Production era.
• What information to include in the Risk Management Plan and Report for better auditability.

Who Will Benefit:
This webinar will provide a methodology that medical device companies can use in establishing a risk management process that is integrated with their product development process. The employees who will benefit include:

• Systems engineers responsible for developing requirements
• Software developers
• Test Engineers
• Quality System auditors
• Engineering managers and personnel
• Regulatory Affairs