Sampling and Sample Handling in Laboratories

Sampling is an important operation within the entire analytical testing process in which only a small fraction of a product is taken. Valid conclusions on the whole test can only be based on representative sampling. Thorough handling of samples is important to ensure integrity of samples. to prevent deterioration and cross contamination, to maintain sample tracking and the chain of custody, and to ensure safe disposal. Correct sampling is thus an essential part of a system of a quality system and for FDA compliance. However, there are no official guidelines which raises lots of questions about sampling and sample handling.

Key Questions:

• What are the requirements of FDA and European agencies for sampling?
• What are expectations from ISO 17025?
• How to ensure and document representative sampling?
• How to write a sampling plan?
• How many samples should we take from a batch to be statistically safe?
• How to define and justify Acceptance Quality Levels for sampling
• How much sample should we take?
• How much reserve sample should we take?
• For how long should samples be stored?
• For how long should reserve samples be stored?
• Who is responsible for sampling?
• FDA requires a sampling plan, what exactly should be the content?
• What is the statistically accepted AQL (Acceptance Quality Level) for sampling?

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the webinar, the speaker will present strategies and give practical recommendations. After the webinar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

For easy Implementation, You will receive:

SOPs:

• Sampling for Analytical Testing (531)
• Handling of Laboratory Test Samples (534)
• Reserve Samples in Laboratories

Checklist:

• Sampling and Sample Handling

Areas Covered in the Session :

• FDA and international GLP/GMP requirements
• Examples for Warning letters and how to avoid them
• Requirements of ISO 17025
• Sampling and sample handling as Part of the analytical process
• Objectives of sampling and sample handling
• Responsibilities for sampling
• Sampling plan and SOPs for sampling and sample handling
• Determining the AQL (Acceptance Quality Levels)
• Statistical sampling 2859, 10725
• Requirements for sampling equipment and tools
• Requirements for sample containers and labeling
• Sampling operating and precautions
• Recommendations for sample handling and transport
• Storing and retention of samples
• Reserve samples: sampling, amount, requirements, storage
• Examples: Starting materials, intermediates, finished products, packaging material
• Documentation for FDA and ISO 17025

Who Should Attend:

• QA managers and personnel
• Analysts and lab managers
• Validation specialists
• Training departments
• Documentation department
• Consultants

Course Director: DR. LUDWIG HUBER

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of (www.labcompliance.com), the global online resource for validation and compliance. He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website (www.ludwig-huber.com).