Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars


 

71 New Usersclub Additions
last update
December 1, 2014

- 20 SOPs
- 23 Examples/Checklists
- 7 Forms/Templates
- 4 Master Plans
- 4 Reference papers
- 13 Warning Letters

 

Five 2-day In-person Interactive GMP, Part11 and Validation seminars available in America, Europe and Asia delivered by Dr. Ludwig Huber. 

 

Now with Qualification of Virtual Networks

With three audio seminars

With 28 SOPs. 

 

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

 

Recent Regulatory Updates in Pharma and Biopharma Compliance

Get a comprehensive update in just one hour

June 3, 2014

 

Comparing GLP with GMP

Learn about similarities and differences and when to apply one or the other

June 5, 2014

 

Validation and Control of Excel Spreadsheets for FDA Compliance

Understand requirements and get tool kits for easy implementation

June 10, 2014

 

Auditing QC Laboratories for FDA Compliance

Learn how to use internal audits in preparation for regulatory inspections

June 18, 2014

 

FDA/EU Compliant IT Infrastructure and Network Qualification

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time

 

Validation and Use of Cloud Computing in FDA Regulated Environments

Comply with GXPs, Part 11, EU Annex 11 and other regulations

Recorded, available at any time

 

Laboratory Equipment Calibration and Qualification according to USP <1058>

With SOPs, Templates and Examples for easy Implementation

Recorded, available at any time

 

Understanding the New EU-GMP Annex 15 on Validation and Qualification

New requirements and strategies for implementation

Recorded, available at any time

 

Understanding Quality by Design for the Pharmaceutical Industry

Introduction to Principles, Regulatory Activities and Industry Practices

Recorded, available at any time

 

Validation of Analytical Methods according to the New FDA Guidance

Understanding FDA's New Lifecycle Approach Towards Method Validation

Recorded, available at any time

 

Impact of Quality by Design on the Analytical Laboratory

Learn through examples on development and validation of analytical procedures

Recorded, available at any time

 

Understanding FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
With tool kit for cost effective implementation

Recorded, available on demand

 

Transfer of Analytical Methods According to the New USP Chapter 1224
With SOPs, templates and examples for easy implementation

Recorded, available on demand 

 

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

With Strategies and best Practice Guides for easy Implementation

 Recorded, available on demand

 

System Suitability Testing for FDA and USP Compliance

Setting parameters and limits for chromatographic and other methods

Recorded, available on demand

 

Analytical Equipment Qualification and System Validation for FDA Compliance

Combining the USP <1058> with the new GAMP(TM) Laboratory Computer Systems Guide

Recorded, available on demand

 

Managing Electronic Raw Data in Regulated Environments

Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU compliance

Recorded, available on demand

 

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available on demand

 

Regulatory Aspects of 'Biosimilar' Drugs

Understand and Implement recent FDA and updated EMA Guidances

Recorded, available at any time

 

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

With SOPs, templates and examples for easy implementation

Recorded, available at any time

 

Understanding and Implementing the New EU-PIC/S Annex 11

Prepare Yourself for the upcoming Inspections and Enforcement

Recorded, available at any time

 

Laboratory Equipment Qualification according to USP <1058>
With SOPs, Templates and Examples for Easy Implementation
Recorded, available at any time

 

Qualification and Use of Virtual Networks in Regulated Environments

With Strategies and Tool Kit for Compliance and System Uptime

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

 

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

Recorded, available at any time

 

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

 

 

 

New Seminar Series: Regular Compliance Updates for (Bio)Pharma)
(free for members of the Labcompliance Usersclub)

Professionals in the pharmaceutical and biopharmaceutical industry must keep themselves up-to-date with ever changing regulations, guidelines, good-practice guides and inspection and enforcement practices.  While there are a lot of good resources available through literature publications, public conferences and through the internet it can be time consuming to find the right information when needed. This is where the seminar helps. In an one hour audio type conference the speaker gives a comprehensive  update on what's new in (Bio)pharmaceutical compliance  and gives practical recommendations for implementation. The seminar is supported by a website with lots of useful information such as weblinks and best practice guides that help to easily implement the new requirements. The website will also post all questions and answers that  came up before, during and after the seminar. The reference material includes slide material in convenient Powerpoint format for further in-house training. The seminar will be conducted up to four times take/year. The first one will take place on June 3.

Excel Spreadsheets again on Target of FDA Inspections

After years of silence about Excel Spreadsheet compliance, the issue comes back again during FDA inspections and Warning Letters. The main deviations are that Excel Spreadsheets are not controlled and qualified. For example, "The investigator noticed that the use of the Excel® spreadsheets in analytical calculations are neither controlled nor protected from modifications or deletion" and "The investigator noticed that the calculation for residual solvent uses an Excel spreadsheet that has not been qualified. We are concerned about the data generated by your QC laboratory from non-qualified and uncontrolled Excel spreadsheets",  "In response to this letter, provide a retrospective evaluation of the analytical values reported where such Excel spreadsheets have been used.". The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-287. Non members can preview excerpts. Attend the new Labcompliance audio seminar "Validation and Control of Excel Spreadsheets in Regulated Environments" to learn how to 'control' spreadsheets and how to qualify and validate new and existing Excel Spreadsheets. 

New FDA Guidance on Post Approval of Manufacturing Changes

This guidance provides recommendations to holders of NDAs and ANDAs regarding the types of changes to be documented in annual reports. The type of changes are: major, moderate, or minor. Specifically, the guidance describes examples of minor manufacturing changes that the FDA has determined will likely have a minimal potential to have an adverse effect on product quality and, therefore, should be documented by applicants in an annual report and submitted to the FDA and can be implemented without the need for FDA approval. The FDA expects NDA and ANDA holders to evaluate and categorize the specific change they are planning to make based on  a justified and documented risk assessment. The guidance with specific examples can be viewed and downloaded from the FDA website

QbD Lessons Learned from an FDA Filing

Trisha Gladd, editor of Pharmaceutical Online and Bioresearch Online, wrote an interesting article about the experience of a pharmaceutical  CMO with implementing QbD. In summary, QbD does require a significant investment of time and money but the end result is a more well-defined and carefully planned manufacturing process. And QbD has other benefits: getting the drug to market quicker, reduced recalls and rejects and minimized post-approval changes. As of May 2014 the article is available on the Pharmaceutical Online website. For other articles from Pharmaceutical Online, click here. Compared to the benefits the pharmaceutical companies have been slow to adopt QbD. One reason is a lack of understanding of the QbD principles and benefits for the industry. To get a better understanding on what it means we recommend to attend the most up-to-date seminars:  "Understanding Quality by Design for the Pharmaceutical Industry" and "Impact of Quality by Design on the Analytical Laboratory"

'Advice' from FDA on Using Excel in Regulated Environments

Excel is frequently used in laboratories, offices and manufacturing as sophisticated  calculator.  Some companies stay away from using Excel and other spreadsheets in FDA regulated because such Out-off-the-Box software does not comply with all FDA requirements. However, with the necessary controls Excel can be brought into compliance. For example, the FDA has developed two internal Information Bulletins on developing and using spreadsheets in regulated environments. Useful advice also is received from FDA inspection reports. To learn everything about how FDA is using Excel in their own regulated environments and about current  regulatory expectations for using Excel, and to receive two FDA Spreadsheet Information Bulletins click here.

FDA publishes new Draft Guidance on Biosimilarity to Reference Products

The guidance with the title "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product" is intended to assist sponsors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to its reference product. It pertains to those products - such as therapeutic biological products - for which pharmacokinetic (PK) and pharmacodynamic (PD) data are required as part of a stepwise approach to developing the data and information necessary to support a demonstration of biosimilarity. Specifically, the guidance discusses some of the overarching concepts related to clinical pharmacology testing for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials. In its final form, this guidance will be one in a series that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009. The guidance is available for reading and download on 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 "Laboratory Compliance Masterplan ". To download your free copy, go to the Laboratory Compliance Packgage website. Scroll down and click on the corresponding ICON on the left (offer expires on May 15 , 2014). Labcompliance offers more than 150 SOPs and examples that help to comply with FDA and ISO 17025 compliance. For titles and ordering of the examples click here.

Audio Seminar Schedule

  1. Recent Regulatory Updates in Pharma and Biopharma Compliance
    Get a comprehensive update in just one hour.
    Recorded, available at any time
  2. Comparing GLP with GMP
    Learn about similarities and differences and when to apply one or the other
    Recorded, available at any time
  3. Validation and Control of Excel Spreadsheets for FDA Compliance
    Understand requirements and get tool kits for easy implementation
    Recorded, available at any time
  4. Auditing QC Laboratories for FDA Compliance
    Learn how to use internal audits in preparation for regulatory inspections
    Recorded, available at any time

New or Updated Sites

Click here to tell others in your company about compliance news

Publishers Note

PUBLISHER'S NOTE: Some of the documents presented in this News section may require registration to the Labcompliance Usersclub to access their information. At the time of the News release, all links to other websites functioned, but Labcompliance cannot guarantee the accuracy of the information and that the links will not disabled.