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50 New Usersclub Additions

- 18 SOPs
- 12 Examples/Checklists
- 5 Forms/Templates
- 2 Master Plans/Primers
- 3 FDA Presentations
- 10 Warning Letters

 

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

 

Eight Steps for Cost-effective Laboratory Compliance
Up-to-date overview, hot topics and trends.
March 29, 2012

 

FDA Compliant Sampling and Sample Handling in Laboratories

Strategies to Avoid Sampling Errors and Ensure Sample Integrity

April 12, 2012.

 

How to Survive FDA's 'New' Inspection and Enforcement Practices

With Industry Proven Tool Kits for Preparation, Conduct and Follow-up

April 26, 2012

 

Ensuring Integrity and Security of Electronic Records for FDA Compliance

Comply with new FDA inspection practices and EU Annex 11 requirements

May 8, 2012

 

Configuration Management and Change Control for Networks and Computer Systems

Changes of Hardware, Firmware, Software, Networks, Documentation

May 24, 2012

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, QSR, and Annex 11.

June 21, 2012

 

Selecting Acceptance Criteria for Regulatory Method Validation

Learn through case studies and get inspection ready documentation

July 10, 2012

 

Qualification and Use of Virtual Networks in Regulated Environments

With Strategies and Tool Kit for Compliance and System Uptime

July 12, 2012

 

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, available at any time

 

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 March 2012

New FDA Guidance on Safety Data Collection

This new draft guidance entitled "Determining the extent of safety data collection needed in late stage premarket and post-approval clinical investigations" is intended to assist sponsors of clinical trials of investigational drug and biological products in determining the amount and types of safety data to collect during late stage premarket and postmarket clinical investigations. The guidance emphasizes a selective and better targeted approach to safety data collection during late stage development or during the postmarket stage based on what is already known about a medical product’s safety profile. The guidance also addresses the circumstances in which it may be acceptable to acquire a reduced amount of safety information during clinical trials. The new draft guidance can be downloaded from the FDA website.

FDA Warning Letter:  Import Alert for Polish API Manufacturer

A Polish API manufacturer received a warning letter as a result of an inspection last fall. FDA considered "cross-contamination of other APIs manufactured at the facility and other deviations as unacceptably high risk" that the manufacturer will remain under FDA Import Alert, and FDA will continue to refuse admission of all articles manufactured the site. This is just one example of FDA's more stringent inspection and enforcement practices. Other examples are: in 2011 FDA has increased the budget for manufacturing plant inspections to $135M$, an increase of 30%, in the same period the number of  warning letters increased by 155%, shipment holds and multiple product recalls have been announced even for global players. Furthermore one company had to pay 500 M$ fine as a result of failed inspections, and inspectors ask for details they never did before. Attend the Labcompliance Audio seminar "How to Survive FDA's 'New' Inspection and Enforcement Practices" to learn everything about FDA's new inspection and enforcement practices.

FDA CDER Launches New Web Education Series on Drug Review Process

CDER has launched a new Web education series called "CDER World." CDER World will expand as new modules are developed based on the CDER Forum for International Drug Regulatory Authorities, which occurs twice a year in the spring and fall. The modules are designed to inform international regulators, as well as health care professionals and the American people, about the CDER drug review process and the CDER mission to ensure the safety and efficacy of human drug products in the United States. The site presently contains The World of Compliance, the World of Generic Drugs and the World of New Drugs. The World of Drug Safety is coming soon.

FDA Continues with Part 11 Inspections and related Warning Letters

Deviations related to FDA's Part 11 are still an issue. A recent example is a warning letter from February 2012. Cited deviations have been related to security, integrity and availability of electronic records. For example, the  letter states: "All employees in your firm used the same user name and passwords", "You did not document the changes made to the software or data stored by the instrument systems", and "Your firm had no system in place to ensure appropriate backup of electronic raw data and no standard procedure for naming and saving data for retrieval at a later date". Also the companies response was inadequate because it lacked sufficient details and a time frame when and how corrective actions will be implemented. .The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-264. Non members can preview excerpts. Attend the Labcompliance audio seminar to learn everything about Part 11 inspections and how to avoid and respond to Warning letters.

Chinese Pharmacopeia 2010 Edition Available in English

The Chinese Pharmacopeia has been translated into English in accordance with the principles and requirements recommended by the Ninth Chinese Pharmacopoeia Commission (ChP) and accomplished by the collective efforts of ChP members, its Secretariat, institutions and organizations. The Chinese Pharmacopoeia 2010 or abbreviated as ChP 2010 - features significant revisions and improvements. The complete document comes in three volumes that include  6773 monographs. The Pharmacopeia is available through the USP website.

"Samples not Representative" cited in FDA Warning Letter

FDA expect sampling to follow a detailed sampling plan to ensure that the samples are representative and to maintain sample integrity through sample transfer and storage. FDA made this clear in a warning letter to an OTC drug manufacturer. . .  The letter reads: "Your firm has not established scientifically sound and appropriate sampling plans. Representative samples are not taken of each shipment of each lot of components for testing or examination." Other statements typically found in FDA warning letters are: Failure to retain reserve samples, reserve samples from representative sample lots or batches of drug products are not examined, storage condition for samples retained for stability testing are not adequately documented,  failure to establish and implement sampling plans based on a valid statistical rationale. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-245. Non members can preview excerpts. Attend the Labcompliance audio seminar to learn everything about FDA compliant sampling and sample handling. .

New FDA Guidance on Acceptance of Foreign Clinical Studies

This new draft guidance entitled "FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions. This guidance document is intended to clarify for sponsors and applicants how they can demonstrate compliance with the requirements of 21 CFR 312.120.3 It provides recommendations for the submission of information, whether in an IND or application for marketing approval for a drug or biological drug product,4 to demonstrate that a non-IND foreign clinical study was conducted in accordance with GCP The new draft guidance can be downloaded from the FDA website.

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 Best Practice Document "SOP: Quality Assessment of Software and Computer System Suppliers". To download your free copy, go to the Part 11 Compliance Package. Scroll down and click on the corresponding ICON on the left (offer expires on March 31 2012). Labcompliance offers more than 130 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

 

  1. Eight Steps for Cost-effective Laboratory Compliance
    Up-to-date overview, hot topics and trends.
    Recorded
  2. FDA Compliant Sampling and Sample Handling in Laboratories
    Strategies to Avoid Sampling Errors and Ensure Sample Integrity
    Recorded
  3. How to Survive FDA's 'New' Inspection and Enforcement Practices
    With Industry Proven Tool Kits for Preparation, Conduct and Follow-up
    Recorded
  4. Ensuring Integrity and Security of Electronic Records for FDA Compliance
    Comply with new FDA inspection practices and EU Annex 11 requirements
    Recorded
  5. Configuration Management and Change Control for Networks and Computer Systems
    Changes of Hardware, Firmware, Software, Networks, Documentation
    Recorded
  6. Validation and Use of Excel Spreadsheets in Regulated Environments
    Comply with FDAs Part 11 and Quality System Regulation (QSR) and with the EU Annex 11
    Recorded
  7. Selecting Acceptance Criteria for Regulatory Method Validation
    Learn through case studies and get inspection ready documentation
    Recorded
  8. Qualification and Use of Virtual Networks in Regulated Environments
    With Strategies and Tool Kit for Compliance and System Uptime
    Recorded

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