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Eleven 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.

 

 

 

June 2017

FDA, EMA and PIC/S Require Procedures for Contingency and Disaster Recovery Planning

Such requirements are spelled out in FDAs Guidance for Industry on  Computerized Systems Used in Clinical Investigations: "When electronic formats are the only ones used to create and preserve electronic records, recovery procedures should be designed to protect against data loss.  OPs should be available that include, but are not limited to recovery, and contingency plans..
The EU/PICS Annex 11 to EU GMPs states in chapter 16: For computerized systems supporting critical processes, provisions should be made to ensure support for those processes in the event of a system breakdown. The time required to bring the alternative arrangements into use should be based on risk and appropriate for a particular system and the business process it supports. These arrangements should be adequately documented and tested.
The requirement is further supported through FDA inspection reports, e.g,.: "There was no written standard operating procedure that included disaster recovery and data back-up. (fdawarningletter.com, WL 029):To learn everything about FDA and EMA expectations business continuity and recovery planning, attend the Labcompliance audio seminar "FDA/EU compliant business continuity and disaster recovery planning"

Report from the EMA-FDA QbD Pilot Program

In March 2011, the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) launched a joint pilot program for the parallel assessment of applications containing Quality by Design (QbD) elements. The aim of this program was to facilitate the consistent implementation of QbD concepts introduced through International Council for Harmonisation (ICH) Q8, Q9 and Q10 documents and harmonize regulatory decisions to the greatest extent possible across the two regions. The program was initially launched for three years. Following its first phase, both agencies agreed to extend it for two more years to facilitate further harmonization of pertinent QbD-related topics. The program officially concluded in April 2016. On April 19, 2017, EMA together with FDA published a report on QbD pilot program. Overall, it is concluded that, on the basis of the applications submitted for the pilot, there is solid alignment between both Agencies regarding the implementation of multiple ICH Q8, Q9 and Q10. The report is available on the EMA website.

11 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, Asia and Europe. For a complete list of workshops with ordering process info and links to pages with individual contents, click here.

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.

 

 

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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.