Why Should You Attend:

In order for a medical device company to meet the requirements for a CE mark, the software must be developed in a manner that meets the requirements of IEC 62304, “Medical device software-Software life cycle processes.”

But. most software development vendors don’t understand IEC 62304 well enough to ensure compliance. As a result, the software is developed in a manner that is not compliant, and the documentation required by IEC 62304, and needed for the FDA submissions, is not created by the developer.

In this webinar, common issues related to ensuring that outsourced software is developed in compliance with IEC 62304 will be addressed. The training will also include an overview of IEC 62304 because the first step to managing a vendor for compliance is to understand the standard.

This course will address complexities in combination products (regulatory, business and quality processes) and break them down into their simple elements. Then these elements will be rebuilt into a practical system that will enhance understanding of the requirements. This understanding of requirements will provide you with the tools you need for developing or revamping your quality system to meet this new paradigm. This will result in a smoother development and approval for your product as well as prevent any "big showstoppers" that delay or threaten your project.

Learning Objectives:

• Combination products, as its name implies, is to FDA regulated products which have different modes of action, in the diagnosis and treatment of disease. The most complex frequent is the drug & device combination.
• Provide an understanding of the differences within the various types of combination products.
• More similarities than differences exist between the GMP's for Drugs and Devices. Principles of all quality systems are the same.
• Only one quality system is required to control manufacturing, testing of combination products.
• Quality Systems for medical devices are more quality system orientated than drug GMP's but the drug GMP's are now advancing.
• The lifecycle differences between drugs and devices impact their approval and regulation.
• Staffing for combination products is much more complex than single products.
• The FDA's draft GMP guidance will be incorporated as applicable. This course is designed to better show specific similarities and differences between manufacturing single and combination products.

This course will address complexities in combination products (regulatory, business and quality processes) and break them down into their simple elements. Then these elements will be rebuilt into a practical system that will enhance understanding of the requirements. This understanding of requirements will provide you with the tools you need for developing or revamping your quality system to meet this new paradigm. This will result in a smoother development and approval for your product as well as prevent any "big showstoppers" that delay or threaten your project.

Learning Objectives:

• Combination products, as its name implies, is to FDA regulated products which have different modes of action, in the diagnosis and treatment of disease. The most complex frequent is the drug & device combination.
• Provide an understanding of the differences within the various types of combination products.
• More similarities than differences exist between the GMP's for Drugs and Devices. Principles of all quality systems are the same.
• Only one quality system is required to control manufacturing, testing of combination products.
• Quality Systems for medical devices are more quality system orientated than drug GMP's but the drug GMP's are now advancing.
• The lifecycle differences between drugs and devices impact their approval and regulation.
• Staffing for combination products is much more complex than single products.
• The FDA's draft GMP guidance will be incorporated as applicable. This course is designed to better show specific similarities and differences between manufacturing single and combination products.

This training class describes the mechanics of a sound maintenance program from a ‘Quality’ perspective, including the major issues that are typically emphasized during regulatory audits. You will learn how to develop thorough maintenance documents that are clear and confusion-free. Additionally, you will discover how to perform and document corrective work in a manner that eliminates ambiguity and misunderstanding.

Areas Covered in the Seminar:

- Minimize operational downtime by maximizing equipment efficiency.
- Create efficient maintenance plans that comply with FDA guidelines.
- Optimize your regulatory audit preparation and execution for facility systems.
- Standardize corrective and preventive work orders to prevent confusion.
- Establish clear procedures for daily monitoring.
- Train your staff for maximum effectiveness.
- Create a 'compliance mindset' throughout your facility department.

Why Should You Attend:

This webinar is designed to provide a comprehensive overview of impurities which must be controlled in pharmaceutical products, detailed review of the guidance documents related to each of the categories of impurities and strategies to address each, including reporting of test results. Topics for discussion include general impurities (not structurally related to the drug substance), such as residual solvents, elemental impurities, and microbial issues, and drug-related impurities, including process impurities, normal degradation products and potential genotoxic impurities.

Who Will Benefit:

Chemists (Research, Quality Control, and CRO) involved with dissolution method development or testing and their managers, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution.

- Laboratory chemists, supervisors or managers responsible for development, testing, release or stability of pharmaceutical drug substances or drug products.
- Quality Assurance or Regulatory Affairs personnel responsible for review or reporting of data for drug substances or drug products.

Why Should You Attend:

Risk analysis is now required by law (GMP). Identification of device design problems prior to distribution eliminates costs associated with warranties, product recalls, and product validation.

FMEA can reveal missing requirements, missing functions, and point out component and manufacturing problems well before process validation. These in turn reduce life cycle costs and reduce the time to market. Design FMEA serves as a central document in the Design Control process Similarly the Process FMEA serves as the central document in the Process Validation qualification.

Who Will Benefit:

This webinar will provide valuable assistance to all Medical Device companies/ manufacturing sites. Those that would benefit most would be:

- R&D, Scientists
- Senior management
- Engineers
- Product Management, Product development
- Manufacturing managers and engineers
- Safety, Reliability, Quality Assurance
- Regulatory
- Purchasing & Production

NOTE : Add another webinar to your shopping cart and get 20% off on its price.

Why Should You Attend:
The trend of recalls of products containing software is up. Historically, software safety has been focused on the software development process and system-level testing.. Having skilled engineers and a rigorous software development process, as required by the FDA is important to help to minimize errors. However, assessing the software development process provides only a partial reliability of the software, and system-level testing that would comprehensively test the software is currently beyond the state of the art except for a very simple system. How we design the software reliability and safety is critical in preventing recalls.

Attend this training to learn proven techniques for designing reliable and safe medical device software that can prevent product recalls.

Areas Covered in the Seminar:

- FDA Quality System Requirements.
- Principles of software reliability.
- Principles of software safety.
- Software requirements analysis methods.
- Software Failure Mode and Effects Analysis.
- Software Hazard Analysis.
- Software structure for reliability and safety.
- Software architecture for reliability and safety.
- Manual code reviews.
- Software verification.
- Software validation.

NOTE : Add another webinar to your shopping cart and get 20% off on its price.

Why Should You Attend:
All CRO's, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning what makes the Good Clinical Practices of Research involving human subjects.

From recruiting subjects to assessing safety of the investigational product and Protocol deviation aversion, this training session covers the high points.

Who Will Benifit:

This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including:

- Sponsor Senior Management
- Project Managers
- CRA Managers
- QA/Compliance persons

NOTE : Add another webinar to your shopping cart and get 20% off on its price.

Why Should You Attend:

This interactive course is designed to provide practical tools for those developing dissolution methods at various stages (including biorelevant methods), and to provide an understanding of the development process for managers, formulators and regulatory affairs/CMC personnel.

Building on the history of dissolution, the participants will be presented with a systematic approach for developing dissolution methods. Validation and transfer of methods will also be addressed. The course emphasizes troubleshooting methods, when changes in dissolution profiles are observed, and understanding the causes for those changes, with ample opportunities to discuss real or hypothetical situations.

Who Will Benefit:

Chemists (Research, Quality Control, and CRO) involved with dissolution method development or testing and their managers, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution.

- QC chemists, supervisors and managers
- R&D chemists, supervisors and managers
- QA Managers and personnel
- Regulatory Affairs personnel

Why Should You Attend:

This one-day course provides information and techniques for handling human resources policies and practices legally and effectively.

Beginning with an overall audit of human resources practices, this webinar covers overall legal requirements, employment policies, employee record maintenance, employment practices, performance management, discipline and terminations.

Each section will give proactive measures and best practices to assure the organization has equitable and effective human resource management.

Duration: Six (6) hours of instruction, one (1) hour lunch, 15 minute break

Who Will Benefit:

- Vice Presidents, Directors, & Managers of Human Resources
- Employment Managers, Chief Talent Officers, Recruiters
- Employee Relations Professionals
- HR Coordinators/Supervisors/Administrators
- HR Analysts
- Supervisors
- Auditors