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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: 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: 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: 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: 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: 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: 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: 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: HIPAA 2016 ?Texting and Emailing
DESCRIPTION
This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, med
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: 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: 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: 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: 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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Boston: 2018 Data Integrity Seminar : FDA/EU Requirements and Implementation
2018 Data Integrity Seminar : FDA/EU Requirements and Implementation
Location 1: Boston,MA
Oct 11 - 12
Description
Data Integrity audits project a moving goal post. Issues that were top warning letter vote getters have made way for newer one
Date Posted: 04-May-18
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