Good Cleaning Validation Practices – 24th – 25th October 2011 Istanbul

  • 0

This cleaning validation training addresses cleaning validation from a life cycle perspective. There is more than one way to achieve a compliant cleaning validation program.

Destin A. Le Blanc provides insights related to understand the cleaning process in a specific situation so effective and efficient programs can be established and executed.

At the end of the course on Good Cleaning Validation Practices, participants should be able to understand and apply:

  • USA and European cleaning validation guidance documents
  • Importance of design/development for an effective program
  • Principles and calculations of residue limits for a wide variety of residue types, routes of administration, and dosage types
  • Selection of analytical methods, along with appropriate levels of analytical method validation
  • Selection of sampling methods and sampling sites, along with proper selection of blanks and controls
  • Appropriate strategies and documentation for sampling recovery studies
  • Cleaning validation master plan and/or policy components
  • Strategies to simplify validation protocols and validation implementation
  • Strategies for grouping to simplify validation
  • Appropriate documentation for cleaning validation protocols and reports
  • Monitoring, revalidation and validation maintenance for validated cleaning process

Who Should Attend

Professionals responsible for various aspects of cleaning validation including:

  • Validation scientists
  • Validation service personnel
  • Production engineers
  • Quality assurance specialists
  • Quality control technicians
  • Analytical chemists
  • Microbiologists
  • Regulatory affairs professionals
  • Pharmacologists
  • Toxicologists
  • Technical support scientists
  • Supervisors, managers and directors of groups supporting cleaning validation

Download Brochure

Click here to download our brochure.


Similar articles:

7 Top Tips for Validating Computer Systems in a Regulated Environment [Video]

The validation of any computer system in a regulated environment is always a tricky task with so many areas to cover. Not only do you have to ensure that the application adheres to 21 CFR Part 11 but it must also be validated to ensure that data integrity is not compromised throughout it’s life cycle.

To help you successfully validate a computer system remember the following:

1. Development Methodology

Select a development methodology that best suits the nature of the system – the risk analysis you do will help decide what level of validation is required.

For example, if you purchase the system from a third party vendor you may be able to leverage some of the testing they have already performed to streamline the effort.

2. Hardware

Select hardware based on capacity and functionality – vendors and IT personnel will guide this part of the process.

3. Opertional Limits

Identify operational limits to establish production procedures

4. Opertional Functions

Identify operational functions associated with the

  1. Users
  2. Processes
  3. Regulations
  4. Company standards
  5. safety requirements

5. Worst Case Scenrios

Identify and test worst-case production scenarios

6. Master Validation Plan

Clearly document the validation process and start by creating a master validation plan to define the effort involved

7. Written Procedures

Ensure the availability of written procedures to maintain the validated state of the computer system.

21 CFR Part 11 - Electronic Records

This video is taken from our online course on 21 CFR Part 11 – Electronic records. Click here to find out more about this course.


Similar articles:

The 9 Golden Rules – Ensuring Laboratory Data Integrity [Video]

The enduring assets of a laboratory’s work are the records that document those activities. When laboratory records are used to support a regulatory function, they are considered to be legal documents.

For records to be considered reliable and trustworthy they must comply with the following criteria:

1. Legible and Understandable

They must be able to be read and understood for the lifetime of the record, without having to refer to the originator for clarification. The information may be needed in five, ten or twenty years’ time, perhaps after the originator is no longer available.

2. Attributable

Who made the record or created the data and when?

3. Contemporaneous

The record must be made at the time the activity was performed

4. Original

The information must not be written on a post-it, piece of scrap paper, sleeve of a lab coat etc. and then transcribed.

5. Accurate

No errors or editing without documented amendments.

6. Complete

All the information and data associated with the analysis is included.

7. Consistent

All elements in the sequence of analysis must be date & time stamped and must be in the expected order.

8. Indelible

Records are made on to controlled documents, such as laboratory notebooks or controlled worksheets, or saved to electronic media.

9. Available

Over the entire lifetime of the record for review, audit and inspection.



Similar articles: