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Houston: Proper CAPA Management by Danielle DeLucy
DESCRIPTION
In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal
Date Posted: 18-Apr-16
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Houston: Introduction to Risk Management: Medical Devices
DESCRIPTION
This webinar will cover Risk Management per ISO 14971 throughout the product lifecycle. Risk Management is an important process to methodically and effectively identifying and mitigating risks in the product design and manufacturing p
Date Posted: 18-Apr-16
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Houston: Internal Audit is a Secret to Medical Device Compliance
DESCRIPTION
Internal Audit is an incredibly powerful tool to identify areas of non-compliance. A well designed audit program is a critical tool in understanding, communicating, and mitigating compliance risk. This webinar will help companies use
Date Posted: 18-Feb-16
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Houston: Due Diligence ? Quality and Compliance Aspects for Medical Device
DESCRIPTION
Mergers and acquisitions are an on-going and important part of the medical device industry. And Due Diligence is a critical part of that process, setting the stage for either success or disaster. Poor due diligence can lead to qual
Date Posted: 18-Apr-16
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FL: Live Webinar Corrective and Preventive Action (CAPA) - Principles of L
Live Webinar Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration
Description
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements a
Date Posted: 08-May-18
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Houston: Medical Devices: Handling, Storage, Distribution, and Installation
DESCRIPTION
Handling, Storage, Distribution, and Installation procedures need to be established for all manufacturers of medical devices. These procedures define and control how devices are handled, stored, distributed, and installed with custome
Date Posted: 15-Apr-16
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Houston: Current Regulatory and Compliance Trends in the Area of Consent Decree
DESCRIPTION
Topic Background:
Many Years Ago Schering Plough underwent the first Consent Decree.
Since, then many years elapsed and the term Consent Decree was foreign to many employees and employers and to Industry overall.
Over the last Sev
Date Posted: 18-Feb-16
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Boston: 2 DAY SEMINAR Effective Compliance Strategies for Complaint Handling,
2 DAY SEMINAR Effective Compliance Strategies for Complaint Handling, Medical Device
Location 1: Boston,MA
Jul 11 - 12
Description
Complaint handling systems have come under intense scrutiny by the FDA in recent years and enforcement trends
Date Posted: 04-May-18
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Houston: Medical Devices - ISO 13485 ? Do you really know what you need to?
DESCRIPTION
A detailed look at each section of the standard.
Real world examples of what to expect, and what to prepare and repeal within the audit guidelines.
What must a documentation system look and feel like to ensure compliance?
These and
Date Posted: 18-Apr-16
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Houston: Auditing the Risk Management File - By Dan O Leary
DESCRIPTION
Medical device manufacturers must implement risk management systems for their devices. This can be a complicated system requiring a lot of work and multiple resources. If it is not correct, the regulatory authorities may require correc
Date Posted: 02-Feb-16
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FL: 3 hrs Webinar - Tools for Human Error Reduction: Developing Metrics
3 hrs Webinar - Tools for Human Error Reduction: Developing Metrics and KPI's (Key Performance Indicators) to minimize Human error rates
Description
Human error is known to be the primary cause of quality and production losses in many industr
Date Posted: 26-Apr-18
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FL: Live Webinar Understanding and Implementing a Quality by Design Progra
Description
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile,
Date Posted: 26-Apr-18
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Houston: Effective Regulatory Inspections
DESCRIPTION
The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able
Date Posted: 18-Apr-16
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FL: Live Webinar Understanding and Implementing a Quality by Design Progra
Description
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile,
Date Posted: 26-Apr-18
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FL: 2018 Update: How to Write Effective SOPs for FDA inspection
2018 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance
Description
Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as
Date Posted: 27-Apr-18
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