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Online Audio Seminars come with 10+ Best Practice guides for easy implementation

 

Ensuring Integrity and Security of Laboratory Data

Comply with new FDA inspection practices and EU Annex 11 requirements

September 8, 2011

 

Good Laboratory Practice Regulations

Introduction and Strategies for Implementation

September 22, 2011

 

IT Infrastructure and Network Qualification: Step-by-Step
With Strategies and Tool Kit for Compliance and System Uptime
October 6, 2011

 

Learning from Recent Warning Letters Related to Computer Validation and Part 11

With Clear Recommendations for Corrective and Preventive Actions

October 20, 2011

 

Cost Effective Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

December 1, 2011

 

Validation of Analytical Methods and Procedures

Design, Conduct and Document for Efficiency and FDA Compliance

December 8, 2011

 

FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

December 15

 

Transfer of Analytical Procedures According to the New USP Chapter <1224>

With SOPs, templates and examples for easy implementation

Recorded, available at any time

 

Verification of Compendial Methods according to the New USP Chapter <1226>
Understand the new risk based approach and  get real world case studies for testing
Recorded, available at any time

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, PIC/S and Annex 11.

Recorded

 

Periodic Review and Evaluation of Computer Systems

With strategies and tools for FDA and EU compliance

Recorded

 

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

Recorded

 

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

Recorded, available at any time

 

Raw Data in FDA Regulated Environments

FDA/EU compliant recording, maintenance and archiving

Recorded

 

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

Recorded, available at any time

 

Development and Validation of Stability Indicating Methods for FDA/ICH Compliance

Sample generation - method development - validation - documentation

Recorded, available at any time

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

Recorded

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

 

with 10+ validation  examples, seminar with FDA's Dennis Cantellops and Ludwig Huber and with 13 SOPs for easy implementation.

 

 

Labcompliance News, August 2011

China's SFDA Going for International GMPs

Since the China State Food and Drug Administration has published new GMPs last year the agency made the agency has been making progress to improve the quality of s as well to improve the quality of its pharmaceutical manufacturing industry. The new standard is based on the well recognized GMPs of the World health Organization. The new GMPs have been effective since March 1 this year. New facilities have to comply right now, existing facilities have a grace period unitil 2010. Read more about history and requirements..

"Excel Spreadsheet not protected against unauthorized Use" cited in FDA 483

For example, the 483 reads: "Impurity calculations are made via unvalidated and unprotected Excel spreadsheet programs which are not managed and controlled to insure unauthorized changes to equations and/or calculations do not occur. Furthermore the 483 stated: "There is no documentation of what the Quality Unit reviewed to assure the correct equation was used and that the correct values were transcribed onto Finished Product Specification Sheets". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-254.  Attend the Labcompliance audio seminar "Ensuring Integrity and Security of laboratory data" to learn everything about data security related FDA inspections and findings and how to avoid inspectional observations..

WHO Publishes Guidance on Technology Transfer

As part of its Technical Report Series, No. 961 the World Health Organization (WHO) has published "Guidelines on transfer of technology in pharmaceutical manufacturing". According to the guidance "Technology transfer can be considered successful if there is documented evidence that the Receiving Unit (RU) can routinely reproduce the transferred product, process or method against a predefined set of specifications as agreed with the Sending Unit (SU)". Several guidance chapters give recommendations for the transfer in production, e.g., processing, packaging and cleaning and for quality control, e.g., analytical method transfer. The document can be downloaded from the WHO website.  For more details on analytical method transfer check the Labcompliance audio seminar and receive tool kits for easy implementation.

New free Tutorial on Risk Management

Labcompliance has published a new free Tutorial with the title: Risk Management in the (Bio)Pharmaceutical and Device Industry. After an overview on literature and regulations the tutorials explains various  approaches, tools and methodologies for risk assessment and management. At the end readers are guided through the entire process step by step. 

Studies Conducted by CRO May Require Reevaluation, FDA Says

The FDA has notified pharmaceutical companies that bioanalytical studies conducted by a Contract Research Organization between April 2005 and June 2010 in support of marketing applications may need to be repeated or confirmed.  The CRO performs bioequivalence and pharmacokinetic testing for a number of pharmaceutical companies. The FDA also announced to send letters to drug sponsors with pending applications, requesting that they either repeat the bioequivalence testing done by the CRO or retest drug samples using a different test laboratory or contractor. The reason is concerns relating to integrity of data. FDA has been taking this action as a result of two inspections of the CRO's bioanalytical facility conducted in 2010, as well as the company’s own investigation and third party audit.  The inspections and audit identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples. To read the full FDA press release, click here. Since quite some time FDA's inspection focus has been on integrity of laboratory data with disastrous consequences for some companies. To learn everything about FDA's laboratory inspection practices and to ensure integrity ob laboratory data, attend the new audio seminar: Ensuring integrity and security of laboratory data.

FDA Commissioner Dr. Hamburg Talked about Sharing Global Inspection Data

Dr. Margaret Hamburg, US FDA Commissioner, delivered a key note address at PIC/S' 40th Anniversary Symposium in Geneva (Switzerland) on May 31, 2011. Dr. Hamburg talked about benefits of FDA's public database COMSTAT which contains FDA inspection results, She encouraged all represented countries to take advantage of this information because they may learn from FDA databases and decide not to duplicate FDA'S inspectional efforts. Dr Hamburg also suggested to work together in global coalitions of regulators in all of FDA areas including GMPs for human and animal drugs. According to Dr. Hamburg, the FDA also believes that global data-information systems and networks are imperative, so that FDA can proactively share data with partners. This would begin with inspectional results or GMP certificates and hopefully extend to include inspection reports and inspection schedules. To download the presentation script, click here,

FDA Warning Letter Issued for Missing Verification of Compendial Methods

FDA expects compendial methods and procedures to be verified under actual conditions of use. This became clear during a recent inspection of a contract testing laboratory which resulted in a warning letter. For example, the letter reads: "Method verifications for compendial tests are not performed. Any method, including compendial methods, must be verified as suitable under actual conditions of use." Other citations included:  no scientifically sound and appropriate product test specifications, no appropriate sampling plans, GC results not traceable to raw data, original chromatograms lost, in-house laboratory procedures non-existent or inadequate,  no SOP to ensure integrity of samples, test methods not adequately documented. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-247.  To learn how to verify compendial methods for FDA regulated environments attend the audio seminar  "Verification of Compendial Methods according to the New USP Chapter <1226>"

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 "Retrospective Validation of Computerized Systems". To download your free copy, go to the Spreadsheet Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on August 31 , 2011). Labcompliance offers more than 130 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Conferences

Audio Seminar Schedule

  1. Ensuring Integrity and Security of Laboratory Data
    Comply with new FDA inspection practices and EU Annex 11 requirements
    September 8, 2011
  2. Good Laboratory Practice Regulations
    Introduction and Strategies for Implementation
    September 22, 2011
  3. IT Infrastructure and Network Qualification: Step-by-Step
    With Strategies and Tool Kit for Compliance and System Uptime
    October 6, 2011
  4. Learning from Recent Warning Letters Related to Computer Validation and Part 11
    With Clear Recommendations for Corrective and Preventive Actions
    October 20, 2011
  5. Cost Effective Computer System Validation: Step-by-Step
    With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation
    December 1, 2011
  6. Validation of Analytical Methods and Procedures
    Design, Conduct and Document for Efficiency and FDA Compliance
    December 8, 2011
  7. FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control
    With Strategies and best Practice Guides for easy Implementation
    December 15, 2011

New or Updated Sites

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Recent Warning Letters and 483's Related to Computer Validation and
Part 11
Labcompliance.com