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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: 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: 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: 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 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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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 medica
Date Posted: 08-May-18
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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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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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DC / U.S. Capitol : 2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar
2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018
Location 1: Washington DC
Jun 28 - 29
Description
GxP records generated by spreadsheet calculations are electronic records and should comply with FDA’s 21 CF
Date Posted: 21-May-18
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DC / U.S. Capitol : 2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar
2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018
Description
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customiz
Date Posted: 17-May-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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DC / U.S. Capitol : 2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar
2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018
Location 1: Washington DC
Jun 28 - 29
Description
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including wides
Date Posted: 04-May-18
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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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