Similar Events |
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: 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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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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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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: 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: 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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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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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: 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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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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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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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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