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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: 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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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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: 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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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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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: Live Webinar :DHF, DMR, DHR, Technical File and Design Dossier - Key R
DESCRIPTION
This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / g
Date Posted: 27-Apr-16
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FL: Live Webinar New and Expected Guidances on Data Standards and Electron
Live Webinar New and Expected Guidances on Data Standards and Electronic Submissions for Drugs and Medical Products
Description
Each FDA center has different guidelines and processes to follow in order to have a successful submission for the re
Date Posted: 30-Apr-18
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FL: Live Webinar New and Expected Guidances on Data Standards and Electron
Live Webinar New and Expected Guidances on Data Standards and Electronic Submissions for Drugs and Medical Products
Description
Each FDA center has different guidelines and processes to follow in order to have a successful submission for the re
Date Posted: 11-May-18
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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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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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Houston: FDA?s New Endotoxin Test Guidance for Human Parenteral Drugs, Biologic
DESCRIPTION
Topic Background:
FDA current thinking regarding Endotoxin testing has changed. Industry needs to adopt this new thinking in order to prevent observations, which lead to further scrutiny by the agency.
Description:
The curren
Date Posted: 15-Apr-16
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FL: Live Webinar FDA’s Final Rule Regarding Device Establishment Registrat
Live Webinar FDA’s Final Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List
Description
Device firms, establishments or facilities that are involved in the production and distribution of me
Date Posted: 27-Apr-18
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