Understand the requirements for investigations when dealing with pharmaceutical drug substances and products; to understand how to effectively control and conduct a laboratory investigation for unknown causes.
Why Should You Attend:
When an out of specification or out of trend result is obtained on an active pharmaceutical ingredient or a pharmaceutical product, both ICH and CFR guidance indicates a need for investigation. At times, the root cause is easily identified and the investigation is conducted swiftly. However, when the root cause cannot be easily accessed by initial review, it can be frustrating to determine the appropriate path for the investigation.
The recent movement of bringing lean and six sigma projects into industry has had a surprising positive side effect. The tools of lean assessment of issues and problems are also excellent tools to conduct laboratory investigations. This training will give guidance on how to break open an issue and will demonstrate the use of some tools for evaluating problem spots. It will also demonstrate how lean tools can aid in establishing as well as controlling the breadth of an investigation.
Areas Covered in the Webinar:
- ICH guidelines for investigations.
- 21 CFR 210 & 211 requirements for investigations.
- Relevant lean tools.
- Initiation of an investigation.
- Controlling the scope of an investigation.
- Finding acceptable resolution.
CMC Turnkey Solutions
Barbara Berglund has been working in the pharmaceutical industry, specifically with sterile Parenteral drugs, for over 10 years. Her experience includes her current role as a QC Manager as well as roles in the laboratory, project management, and clinical trial manufacturing. The QC group she manages is directly responsible for method transfer and validation activities in support of contract manufacturing clients. She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and Pharmacological and Physiological Science. She received her PMP certification in 2007 and her Green Belt certification in 2008.
This webinar will provide valuable assistance to all personnel in:
- QC functions in general
- QC testing groups
- QC investigation groups
- QA reviewers and investigators
- Manufacturing personnel who support investigations
- Management teams who need to understand investigational pathways