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Auditing Biopharma APIs
API GMPs Training
Process Validation
Compliance: Analytical Labs
Compliance: Proc. Development
Part 11 Compliance
Intro to GMPs
API GMPs Overview
Process Val Overview

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GMP Training Seminars

ComplianceNet, Inc. offers a variety of GMP training courses to help your company achieve compliance with federal and international regulations.  We regularly present seminars at international conferences.  Visit the Upcoming Events page to see when the next course is scheduled.

We can also bring these courses to you.  Instead of paying for travel and lodging for only one or two employees to attend a conference, why not custom tailor a training seminar to fit your needs and let everyone attend in the comfort of your own conference room?

The following courses are currently available.  Customizations of these courses or additional courses can also be arranged.  Email us for more information.

 
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Auditing and Compliance for Biopharmaceutical APIs:  Provides a thorough overview of current production and laboratory techniques for producing  biopharmaceutical APIs.  Also covers basic compliance requirements and techniques for conducting an effective audit.  

 

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Compliance for Biopharmaceutical API Process Validation:  Describes requirements for a compliant process validation program and how to avoid major pitfalls and retain maximum efficiency.

 
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API GMP Compliance:  Training on ICH Q7A.  Focuses on the specific, detailed FDA and international recommendations on how to apply GMPs that are missing from the more generic Finished Products regulations.  

 
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Building in Compliance, Analytical Laboratories:  How to set up an Analytical Laboratory so it can be fully GMP compliant, yet still retain its efficiency.  Differences are pointed out for labs working on early phase clinical products vs. marketed products.

 

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Building in Compliance, Process Development: How to ensure that Process Development work can be captured in a GMP compliant manner so it can be used to support product filing claims and process validation.

 

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21 CFR Part 11 Compliance:  How to apply the Electronic Record and Electronic Signature regulations in your environment and key pitfalls to avoid.  Includes an overview of the regulation and how it applies to various applications, spreadsheets, network environments, etc.

 
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Introduction to GMPs:  An introductory level course specific to biopharmaceuticals.

 
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API GMP Compliance Overview:  A two hour overview summarizing the key points of  ICH Q7A.  Focuses on the specific, detailed FDA and international recommendations on how to apply GMPs that are missing from the more generic Finished Products regulations.  

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Compliance for Biopharmaceutical Process Validation Overview:  A two hour overview summarizing the key requirements for Process Validation for biotech firms.

 

FDA on Training

Training and Education are one of the best preventive and responsive investments a firm can make!

Training should be an integral and fundamental thread that holds the success of your firmís programs together to assure conformance to the act.

Be sure training programs reflect current practices and procedures.

Keep abreast of what others may be doing.

Steven Niedelman, FDA
Presentation at PDA
October 2002


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