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Latest Compliance Update for Computer Systems

Learn from FDA and Industry Practioners and get Tools for Implementation
June 18, 2009

 

IT Infrastructure and Network Qualification
Introduction and Strategies for Compliance and System Uptime
Recorded

 

Traceability in Chemical Analysis
With strategies and tools for ISO 17025 and FDA Compliance
Recorded

 

Effective Verification of Compendial Methods
Understanding USP and FDA Requirements and get Tools for Implementation
May 14, 2009

 

Auditing Laboratories for FDA and ISO 17025 Compliance
Preparation - conduct - follow up - documentation
June 18, 2009

 

Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
Comply with the FDA and international guidances
July 9, 2009

 

Validation and Use of Excel® Spreadsheets in Regulated Environments
With FDA's
Dennis Cantellops

Recorded

 

Labcompliance News, May 2009

Review of IVT's 10th Computer System Validation (CSV) Conference

The 10th annual CSV conference was held in the Arlington Sheraton Hotel. Attendees did get an update on CSV requirements and recommendations for cost effective implementation of CSV and other Part 11 controls. FDA's software and computer system compliance expert and Part 11 task force member John Murray gave a keynote presentation on FDA's findings when reviewing CSV documents. John Murray also answered questions about the status FDA's 21 CFR Part 11.  Most valuable for practical implementation have been 28 workshops and Interactive discussion sessions. The conference has been chaired Labcompliance editor Dr. Ludwig Huber. He will make key learnings and recommendations from the conference available in an upcoming audio seminar.  For more information about the conference, click here.

New FDA Guidance on the Submission of Bioequivalence Data.

The FDA released a new new draft guidance which is intended to assist abbreviated new drug application (ANDA) applicants in complying with the new requirements in the final rule on the submission of bioequivalence data published in the Federal Register in January 2009. The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The draft guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs, and is applicable to BE studies conducted during both preapproval and postapproval periods. The draft guidance can be downloaded from the FDA website.  

Is it a Cosmetic or a Drug. FDA. or Both? FDA Provides Answers.

The legal difference between a cosmetic and a drug is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim, without adhering to requirements for drugs. Sometimes its difficult to decide if a product is a cosmetic or drug. .

ICH Working Group Answers Questions about Q8/Q9/Q10

Obviously there are many questions about implementation of ICH guidelines Q8/Q9/Q9. In response to this ICH published a document with most frequently asked questions and answers on its website. Questions are related to design space, release testing, implementation of pharmaceutical quality systems, software solutions for implementation, impact on GMP inspections and knowledge management.

New Version 2.0 of the ISO 17025 Accreditation Package Released

On May 15 Labcompliance has released a new major revision of the popular ISO 17025 Accreditation package. The new version includes 8 new SOPs, an updated quality manual,  5 new checklists and 3 new forms. In addition most other key documents have been updated to reflect most recent recommendations from official accreditation committees and laboratory quality system experts. For additional information and ordering, click here.

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the SOP: Measurement Uncertainty in Chemical Testing. To download your free copy, go to the ISO 17025 Accreditation Package website.  Scroll down and click on the corresponding ICON on the left (offer expires on June 12, 2009). Labcompliance offers more than 100 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

New Audio Seminar Schedule

  1. Latest Updates for Computer Validation and Part 11 Compliance
    Learn from FDA and Industry Practioners and get Tools for Implementation
    Recorded, available with all reference material at any time
  2. Auditing Laboratories for FDA and ISO 17025 Compliance
    Preparation - conduct - follow up - documentation
    Recorded, available with all reference material at any time
  3. Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
    Comply with the FDA and international guidances
    Recorded, available with all reference material at any time

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