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Houston: FDA Inspection Preparation and Management: Important Considerations
DESCRIPTION
This webinar is intended to provide practical and actionable information and guidance on how to proactively prepare for a sustainable FDA inspection and to better manage FDA inspection processes including key points of consideration.
Date Posted: 18-Feb-16
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: How to host an FDA inspection and avoid 483's
DESCRIPTION
FDA must inspect every class II or III medical device manufacturer every two years. This course will explain how to prepare for an inspection including assigning personnel to specific tasks during the audit, facility requirements to s
Date Posted: 18-Apr-16
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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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Houston: US EU and Japan GMP Requirements: Practical ICH Area Differences
DESCRIPTION
This 90 minute webinar will help you gain a detailed overview of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will help prepare you for regulatory inspections in these countries.
Why Sho
Date Posted: 18-Apr-16
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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: 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: FDA vs Health Canada: Similarities and Differences by FDA Expert
DESCRIPTION
Successful interaction with regulatory agencies can mean the difference between product license approvals and rejections; the difference between successful and unsuccessful PAI and routine inspections. Not all regulatory bodies are cr
Date Posted: 15-Apr-16
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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: 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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Houston: Understanding the Regulatory Requirements for the Over the Counter
DESCRIPTION
The US FDA?s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs.
To introduce OTC (nonprescription) drug products into the U.
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: 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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FL: Live Webinar Construct and Manage the Technical File and Design Dossie
Live Webinar Construct and Manage the Technical File and Design Dossier
Description
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the glo
Date Posted: 30-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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