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62 New Usersclub Additions

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

last update
August 3,  2018

 

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

 

 

Validation and Control of Excel Spreadsheets for FDA Compliance
Understand requirements and get tool kits for easy implementation

Recorded, available at any time

 

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.

 

 

 

July 2018

What is the right Audit Format: Pooled or Individual CGMP audits?

Recommendations are given in an on-line article published by PharmaceuticalOnline. An important auditing decision is whether to use an individual or pooled audit. Recommendations are given for different situations, for example, individual audits are recommended when a new product or supplier is added. On the other hand, a pooled audit is recommended for Off-The-Shelf, widely used products and services. To read the full article, click here.

"Incomplete Records" Draw FDA Warning Letter

FDA requires recording complete records from a sequence of analytical runs. This includes successful runs but also failed runs. It also includes system suitability test runs an well as trial runs. This became obvious a warning letter to an API manufacturer, The company did neither record paper nor electronic records of some failed analysis. The warning letter reads: "Your firm does not ensure that complete data from testing of your API are included in the official batch record and reviewed by your quality unit. Your firm does not ensure that complete data from testing of your API are included in the official batch record and reviewed by your quality unit. For example, you reported passing results for related substances testing of (b)(4) lot #(b)(4) analyzed starting at (b)(4) on July 28, 2015. However, our investigator found unreported analyses including out-of-specification (OOS) results for the same lot acquired earlier on the same date, and on the next day as the reported results. You failed to include this data to be reviewed by your quality unit prior to the release of the lot. Our investigator documented the same pattern with other products not intended for the U.S. market.
FDA related this deficiency to and inadequate quality system; "Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture." Furthermore the FDA strongly recommended retaining a qualified consultant: "We strongly recommend to retain a qualified consultant to assist in your remediation"
The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 313).

 

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