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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

 

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

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

Recorded

 

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

 

Implementing the New USP Chapters 232/233 for Elemental Impurities

Learn how to comply with FDA, USP and ICH Requirements

July 26, 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

 

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

 

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 April 2012

"Your Response is not Adequate, Because .....": is the most frequent Warning Letter statement

When you look at recent FDA warning Letters you regularly will find a statement such as "Your response to the 483 Inspectional Observation is not adequate because you failed to .....", The statement is followed by reasons why the response failed. This is a pity because had the response been "adequate" in many a warning letter could have been avoided. Typically companies responded with a corrective action but it may not have been detailed enough, it may not have included a preventive action plan or the corrective plan may not be global enough. The Labcompliance users club sites include many such examples for Pharma manufacturing and quality control (258, 256), Contract Labs (264) Food manufacturing (272), API, manufacturing (259) , devices (267, 269, 271) and dietary supplements(268). Scroll down to the numbers listed above. Non members can preview excerpts Attend the Labcompliance Audio seminar to learn everything about how to respond to FDA 483 Observations to avoid Warning Letters.

PIC/S publishes Inspection Guide on Quality Risk Management  Systems

The Guide was added on April 2 to the popular "Aide Memoire" series of the Pharmaceutical Inspection Convention/Cooperation Scheme. The series has been developed as guideline for inspectors but are also useful training tools for the industry. The new 10-page document is organized in six chapters. It should contribute to a harmonized approach for inspection of QRM in industry between the different PIC/S Members. Other Aide-Memoires are available for inspection of QC Laboratories, for inspection of API Manufacturers and for for inspection of Biotechnology Manufacturers. The global importance of these has  significantly increased since the US FDA joined PIC/S last year and more and countries are applying for membership.

Number of FDA Warning Letters still Increasing

FDA has changed the inspection enforcement practices: the number of inspections is increasing with a much higher number of 483 inspectional observations and warning letters. Here are  and just a couple of citations from the last 5 weeks: You did not perform a second person verification of the weighing/measuring. We recommend that you seek the advice of a third-party consultant to assist your firm with a complete evaluation of your firm’s compliance with CGMP requirements. FDA expects you. to undertake a comprehensive and global assessment of your manufacturing operations to ensure that the drug products you manufacture, conform to FDA requirements, poor aseptic practices, e.g.,: operators leaning halfway in and out of the class 100 area while performing interventions over opened bottles your response is inadequate because it fails to describe how this and other sampling will be documented to ensure all necessary samples are taken. 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 and receive 50 recent FDA warning letters/483s.

12 Months FDA Update Presented by FDA Officials

The update has been presented by Ilisa B.G. Bernstein  and Connie T. Jung, RPh, PhD, from CDER's Office of Compliance at the APhA Annual Meeting in New Orleans, LA, on March 11. The objective of the presentation was to describe FDA activities during the last year and to state how changes in FDA regulations and actions will affect the conference participant’s. The 50-page slide presentation includes includes statistics on new drug approvals and on applications of generic drugs. Quite interesting was the information on drug product recalls from 2007 to 2012 . It shows an increasing trend with a big jump in the first quarter of FY 2012.  The presentation can be viewed on the FDA website.

Consent Decree requests Drug Manufacturer hiring 3rd Party Auditors to resolve "Data integrity" Issues

As follow-up of several FDA inspections and import alerts the U.S. Department of Justice (DoJ) filed a consent decree requesting an Indian based drug manufacturer hiring an external expert to control the integrity of the company's regulated manufacturing and laboratory records. Affected are three facilities in India and one in the U.S. The  external expert is expected to conduct a thorough internal review at the facilities and to audit applications containing data from those facilities, withdraw any applications found to contain false data and set up a separate office of data reliability within the company. Learn how to build integrity into all regulated records in your company before the next FDA inspection in the seminar: "Ensuring integrity and security of electronic records for FDA compliance"

EMA answers Frequently Asked Questions related to Biosimilar Products Applications

The Q&As have been published on a 33-page document. It provides an overview of the EMA position on issues, which are typically addressed during the course of Pre-Submission Meetings held between EMA and users of the Centralized Procedure. The guidance information and successful Pre-Submission Meetings should enable Applicants to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated speedily. Pre-Submission Meetings will also enable Applicants to establish contact with the EMA staff closely involved with the application as it proceeds. The document is available on the EMA website.

"Rationale for inspection of Reserve Samples is not based on Statistical Assessment" draws FDA 483

Missing visual inspection of reserve samples and inadequate frequency has been cited in an FDA 483 inspectional observation. The 483 reads "Reserve samples from representative sample lots or batches of drug products are not examined visually at least once for evidence of deterioration" and "Rationale for inspection of reserve samples is not based on acceptable statistical sound assessment" In addition the FDA found that ".The sample size used by the QC Microbiology Laboratory to determine sub-visible particulates in your small volume parenteral products is not scientifically sound".In addition The 483 can be downloaded from the Labcompliance Usersclub. Scroll down to W-266. Non members can preview excerpts Attend the Labcompliance audio seminar to learn everything about FDA compliant sampling and sample handling. .

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: Disaster Recovery of Computer Systems". To download your free copy, go to the Computer System Validation Package.. Scroll down and click on the corresponding ICON on the left (offer expires on May 10, 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. How to Survive FDA's 'New' Inspection and Enforcement Practices
    With Industry PRecorded
    April 26, 2012
  2. Ensuring Integrity and Security of Electronic Records for FDA Compliance
    Comply with new FDA inspection practices and EU Annex 11 requirements
    Recorded
  3. Configuration Management and Change Control for Networks and Computer Systems
    Changes of Hardware, Firmware, Software, Networks, Documentation
    Recorded
  4. 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
  5. Selecting Acceptance Criteria for Regulatory Method Validation
    Learn through case studies and get inspection ready documentation
    Recorded
  6. Qualification and Use of Virtual Networks in Regulated Environments
    With Strategies and Tool Kit for Compliance and System Uptime
    Recorded

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