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Seven 2-Day life seminars with 
Dr. Ludwig Huber

For titles, contents and dates, click here

 

62 New Usersclub Additions

- 19 SOPs
- 21 Examples/Checklists
- 8 Forms/Templates
- 2 Master Plans
- 12 Warning Letters 

last update
April 10,  2017

 

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

 

Quality by Design (QbD) for Development and Validation of Analytical Methods

With focus on the analytical lifecycle
Recorded, available at any time

 

FDA Compliant IT Infrastructure and Network Qualification 

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time

 

Ensuring Data Integrity for FDA/EU Compliance
Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid records
Recorded, available at any time

 

Understanding the new Revision of USP <1058> 
With examples and procedures for effective implementation

Recorded, available at any time

 

Understanding the New FDA Guidance for Validation of Analytical Methods

With 10+ best practice guides for easy implementation

Recorded, available at any time

 

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

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available at any time

 

Transfer of Analytical Methods According to New FDA, USP and EU-GMP Guidelines
With SOPs, templates and examples for easy implementation
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

 

Understanding the New FDA Data Integrity Guidance
With examples and procedures for effective implementation

June 22, 2017

 

Contingency and Disaster Recovery Planning for Computer Systems
To Ensure Business Continuity and Compliance
June 26, 2017

 

Analytical Instrument Qualification According the new Revision of
USP <1058>
 

With SOPs, Templates and Examples for easy Implementation
Recorded, available at any time

 

FDA/EU Compliant Handling of OOX Test Results

Learn how to investigate out-of-trend (OOT) and out-of-expectation (OOE) vs. OOS results

Recorded

 

Understanding Quality by Design for the Pharmaceutical Industry

Introduction to Principles, Regulatory Activities and Industry Practices

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

 

Managing Electronic Raw Data in Regulated Environments

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

Recorded, available on demand

 

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

 

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

 

 

 

May 2017

FDA Clarifies Details on "Review of Electronic Audit Trail"

FDA requires to review electronic audit trail records. There have been frequent questions related to "who in the organization" should perform the review the audit trail and related to the frequency of audit trail review, meaning that should all critical batch records be reviewed or could it be a fraction. The main question related to the frequency came from quality control laboratories with lots of analytical tests per day. The FDA answered both questions in the guide "Data Integrity and CGMP compliance". The guide states "Audit trails that capture changes to critical data should be reviewed with each record" and "Control records, which includes audit trails, must be reviewed and approved by the Quality Unit."  Additional advice came from a recent warning letter observation: the procedure you implemented on January 11 This also means that audit trail of each critical record should be reviewed. The warning letter can be downloaded from the Labcompliance Usersclub.  Non members can preview excerpts (scroll down to 308). To learn more about the FDA Integrity-CGMP Guide attend the Labcompliance seminar: "Understanding the New FDA Guidance: Data Integrity and Compliance with cGMP
With examples and procedures for effective implementation". The seminar comes with 10+ best practice guides such as the SOP: Review of electronic audit trail.

Deviations related to the Quality system #1 in the MHRA GMP Inspection Deficiency Data Trend 2016

Like in 2015 Quality Systems related deviations appeared to be number one in the MHRA GMP inspection deficiency data trend. Number 2 is Sterility Assurance  followed by Production, Complaints and Recall, Qualification/validation, Premises and Equipment, Computerized Systems, Personnel, Documentation and quality Control. The report can be downloaded from the MHRA website.

Armenia / SCDMTE & Saudi Arabia / SFDA to apply to PIC/S

The Scientific Centre of Drug and Medical Technology Expertise (SCDMTE) of Armenia officially announced to the Committee that it would presently be submitting a membership accession application to PIC/S, further to its pre-accession application completed in 2014.
The Saudi Food and Drug Authority (SFDA) was invited to attend the Committee meeting as guest and updated the Committee on its intent to lodge a PIC/S pre-accession or accession application in the near future
For more information on PIC/S activities, click here

Seven New In-Person Seminars in remaining 2017 with Dr. Ludwig Huber

Labcompliance has extended the offerings for in-Person workshops in several areas: "Data Integrity: FDA/EU Requirements and Implementation", "Validation and Part 11 Compliance of Computer Systems and Data", "GMP Compliance for Quality Control and Contract Laboratories", "Analytical Method Validation, Verification and Transfer", and "Analytical Instrument Qualification and System Validation". All workshops can be delivered as public and as in-house workshops. Currently the workshops are offered in USA and Europe. For a complete list of workshops with ordering process and links to pages with individual contents, click here.

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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.