Medical Devices

$199.00
Design Verification and Validation For Medical Devices and Combination Products

 October 24 2024
 12 : 00 PM EST    
 90 Minutes
Design Verification and Validation For Medical Devices and Combination Products

Verification and validation of design inputs is a critical step in the development of medical devices. It is the objective evidence that the developer developed what they set out to develop and the final product meets its design goals and needs of the end user. Without proper verification/validation of inputs, it is not possible to prove to regulatory agencies that you have a product which is safe and effec..

$199.00
Human error reduction in GMP manufacturing/floor

 October 24 2024
 01 : 00 PM EST    
 90 Minutes
Human error reduction in GMP manufacturing/floor

If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of quality control unit.” and it states that “(a) There shall be a quality control unit that shall h..

$199.00
How do you use FDA Guidance Documents and Recognized Standards – Perspective of a Consultant?

 January 15 2025
 01 : 00 PM EST    
 60 Minutes
How do you use FDA Guidance Documents and Recognized Standards – Perspective of a Consultant?

This event will help you to learn about the FDA’s Guidance Documents and their recognition of standards. The FDA is the regulator for medical devices, and they want to ensure products are safe and effective. An optimal way of doing so is through the use of standards. Standards are developed by a cross-section of personnel from clinical and technical areas. The FDA is one of those stakeholders which allows t..

$200.00
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

 Recorded Webinar
 90 Minutes
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Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges. The approach to developing software, performing validation, and maintaining a sy..

$200.00
Equipment Qualification and Validation of Processes

 Recorded Webinar
 90 Minutes
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Equipment Qualification and Validation of Processes

The course will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. This course will provide discussion on European and FDA regulations as well as global harmonization and expectations. The course will also cover specific aspects of equipment qualification and process validation, such as protocol writing, methodology and performance, report writ..

$200.00
FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities

 Recorded Webinar
 90 Minutes
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FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities

This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical in order to develop the appropriate strategy, policies and procedures to ensure compliance.Areas CoveredPros and cons of using social media venuesCompliant use of Social Media i..

$200.00
Implementing a Change Control Quality System Successfully

 Recorded Webinar
 60 Minutes
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Implementing a Change Control Quality System Successfully

This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..

$200.00
Software development for Medical Devices under IEC 62304

 Recorded Webinar
 60 Minutes
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Software development for Medical Devices under IEC 62304

IEC 62304 is both a recognized consensus standard by the FDA and a harmonized standard in the EU; therefore, being compliant with the standard is the most expedient path forward for medical device products that are or contain software. IEC 62304 is also called out as a standard under the IEC 60601-1 umbrella and thus compliance to 62304 is also the best path through product safety testing (if applicable to ..

$200.00
Standards – Fact, Fiction or Fad?

 Recorded Webinar
 60 Minutes
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Standards – Fact, Fiction or Fad?

This event will help you to learn what the value of standards are including how and when to engage in the development and use of the standards.  You will hear some examples of best practices as well as Faux pas’s. You will learn about the various types of standards and what being involved brings you. You will hear about potential tools and the value of relationships and communications in the standards ..

$200.00
2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

 Recorded Webinar
 90 Minutes
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2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..

$200.00
21 CFR Part11 Compliance

 Recorded Webinar
 60 Minutes
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21 CFR Part11 Compliance

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants t..

$200.00
5S for Operators

 Recorded Webinar
 90 Minutes
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5S for Operators

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. One method to improve productivity and reduce human error is the “5S Method”. This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler..

$200.00
Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

 Recorded Webinar
 90 Minutes
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Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

Auditing is a critical aspect of an overall data integrity assurance plan. To successfully audit the integrity of data, auditors must possess specific knowledge, insights, and skills. A solid audit strategy and plan are critical to providing the highest degree of assurance that no data integrity breaches have occurred, short of 100% verification (which is unfeasible in an industry that generates large volum..

$200.00
Advertising and Promotional Material Compliance and Review Process

 Recorded Webinar
 60 Minutes
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Advertising and Promotional Material Compliance and Review Process

The information obtained will enable the effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, strategies for mitigating risks, and making challenging decisions. You will hear about the opportunities for input from regulatory agencies at critica..

$200.00
Answering and Replying to an FDA 483

 Recorded Webinar
 60 Minutes
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Answering and Replying to an FDA 483

A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or..

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