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Ten 2-day in-person seminars with 
Dr. Ludwig Huber in 2017

For titles, contents and dates, click here

 

62 New Usersclub Additions
last update
September 12, 2016

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

 

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

 

Understanding the Final FDA Guidance for Validation of Analytical Method

With 10+ best practice guides for easy implementation

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 with all reference material

 

Understanding the New FDA Data Integrity Guidance
With examples and procedures for effective implementation
Recorded, available at any time with all reference material

 

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

Recorded, available at any time with all reference material

 

Integrity of Laboratory Data for FDA/EU compliance

Understand and implement data integrity through the entire data life cycle
Recorded, available at any time with all reference material

 

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

With focus on conducting the risk assessment process

Recorded

 

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 with all reference material 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

 

Understanding the Final FDA Guidance for Validation of Analytical Methods

With 10+ best practice guides for easy implementation

Recorded, available at any time

 

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

With SOPs, Templates and Examples for easy Implementation
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

 

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

 

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

Learn how to design robust analytical for easy transfer and to avoid OOS situations

Recorded

 

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

 

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

 

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

 

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.

 

 

 

FDA Proposes Amending GLP Regulations

The Food and Drug Administration (FDA) is proposing to amend the regulations
for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. We are proposing additional management responsibilities and standard operating procedures (SOPs) consistent with the proposed requirement for a GLP Quality System. We also propose to
revise the testing facility definition to reflect current practices for the conduct of nonclinical laboratory studies, particularly multisite studies. These proposals are intended to build quality into planning, conducting, and reporting a nonclinical laboratory study and to help ensure data quality and integrity. The proposed changes can be downloaded from the FDA website.

Training material only available in English for staff not familiar with English language draws FDA warning letter

FDA expects training material and other documentation for staff not familiar with English language to be in local language. This became obvious in a warning letter that reads: "While a significant number of your contract employees do not speak English, You only provided English training materials to these employees" In addition the warning letter noted "We also found an employee’s failing equipment qualification training assessment form in the trash, yet that employee’s official file showed passing results. According to your company policies, personnel with failing scores must be retrained, but your firm was unable to provide evidence of retraining in the employee’s official record" The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 303).

New ICH Concept Paper for Bioanalytical Method Validation

During the development of chemical and biological drugs, bioanalytical methods are used in non-clinical and clinical studies such as pharmacokinetic, toxicokinetic, bioavailability, bioequivalence, dose finding and drug-drug interaction studies, etc., in order to describe the exposure to the drugs and their metabolites. On October 16, 2016, ICH proposed a new multidisciplinary guideline that will apply to the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. This guideline will provide recommendations on the scientific regulatory requirements for bioanalysis conducted during the development of drugs of both chemical and biological origins. This will result in the harmonization of current regional guidelines/guidances and support streamlined global drug development. The concept paper can be downloaded from the ICH website.

Testing into Compliance Cited in 483 Inspectional Observation

For example, observation 1 of the 11-page 483 reads: Raw  materials, intermediates and finished analytical results found to be failing specifications or otherwise suspect (e.g., OOT) are retested until acceptable results are obtained. These failing or otherwise suspect results are not reported. Other observations included:  Samples are not analyzed according to established laboratory test method procedures, selected injections were not reported in the official QC data package, the stand-alone computerized system does not have sufficient controls to prevent unauthorized access to, changes to, or omission of data files and folders. records are not completed contemporaneously, laboratory samples are not adequately controlled to prevent mix-ups, analytical instruments are not calibrated, qualified, or maintained appropriately. The inspectional observation can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 304)

Ten New In-Person Seminars 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, Europe and Asia. 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.