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Houston: CAPA for Medical Device Companies
DESCRIPTION
This webinar will help you ensure an efficient and effective CAPA process leading to improved quality and compliance for your company. You?ll learn how to streamline and monitor your process to ensure compliance and improved performan
Date Posted: 18-Feb-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: 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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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 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: Implementing a Change Control Quality System Successfully
DESCRIPTION
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 s
Date Posted: 15-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: 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: Preparing for Regulatory Audits by Carlson E. Patterson
DESCRIPTION
This seminar will provide an overview of water systems used for pharmaceutical manufacturing. We will cover validation, monitoring, and analyzing data results. What data collected means, how excursions should be handled, and what acti
Date Posted: 15-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: 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: 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: Live Webinar Design Control Under 21 CFR 820 (the CGMPs) and ISO 13485
Live Webinar Design Control Under 21 CFR 820 (the CGMPs) and ISO 13485
Description
The FDA CGMPs (21 CFR 820.30) and ISO QMS’ (ISO 13485:2016 7.3) expect companies to perform meaningful, results driven Design Control act
Date Posted: 27-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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FL: Live Webinar The prevention of human error in pharmaceutical manufactu
Live Webinar The prevention of human error in pharmaceutical manufacturing
Description
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to
Date Posted: 02-May-18
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