This 60-minute webinar will continue the discussion into risk-based inspectional techniques of the Quality System, and will conclude with a look into formulating comprehensive observation responses. Writing and responding to findings from the quality system involves a unique approach due to the critical nature of the information, often determining the difference between accepting or rejecting a batch (or worse). By framing the situation through a quality risk management (QRM) lens focusing on patient safety, we are able to communicate more clearly with those who may not have participated in the inspection but will ultimately make the final decision regarding the need to address the issue (or not).

We will discuss:

• Case studies of previous significant regulatory actions (e.g. 483’s/Warning Letters)

• How to write meaningful and effective responses using Quality Risk Management (QRM) tools

In addition, for those interested, this webinar offers an additional 30 minutes for Q&A upon completion of the presentation.

This 60-minute webinar includes a discussion of advanced techniques for inspection of the quality system.  We will discuss specific inspectional approaches that provide risk-based oversight of the quality system (APIs and drug products), including document management, complaints, change control, and investigations, among others. Effective auditing involves the ability to allocate limited time & resources to those areas of greatest reward – with the ultimate goal of achieving company-wide improvements based on the identification of individual findings/observations. Pursuing the most meaningful observations, therefore, is a key component for success, and can be achieved most effectively through a risk-based approach using critical thinking. This webinar will discuss inspection approaches that an investigator may use during the evaluation of the quality system, for quick and effective identification of areas of concern, with the goal of achieving long-lasting system-wide improvements that ultimately lower costs and result in the production of a higher quality product.

We will discuss:

• How to identify triggers during a review of paper-based GMP records

• Identifying inadequate investigations that could lead to increased risk to product quality

• Reviewing validation packages for unacceptable risk

• Effective interview techniques

• Critical thinking during an inspection

• What are triggers and how do I identify them?

In addition, for those interested, this webinar offers an additional 30 minutes for Q&A upon completion of the presentation.

This 60-minute webinar will continue the discussion into risk-based inspectional techniques for the QC Laboratory and will conclude with a look into formulating comprehensive observation responses. Writing and responding to findings from the laboratory system involves a unique approach due to the critical nature of the data collected and reported, and the ability to write and communicate clearly often determines the difference between accepting or rejecting a batch (or worse). By framing the situation through a quality risk management (QRM) lens focusing on patient safety, we are able to communicate more clearly with those who may not have participated in the inspection but will ultimately make the final decision regarding the need to address the issue (or not).

We will discuss:

• Case studies of previous significant regulatory actions (e.g. 483’s/Warning Letters)

• How to write meaningful and effective responses using Quality Risk Management (QRM) tools

In addition, for those interested, this webinar offers an additional 30 minutes for Q&A upon completion of the presentation.

This 60-minute webinar includes a discussion of advanced techniques for the inspection of QC laboratory systems. We will discuss specific inspectional approaches that an investigator may take to provide risk-based oversight of analytical and microbiological test methods, instrumentation, and procedures (APIs and drug products), including raw materials, intermediates, and finished product. Effective auditing involves the ability to allocate limited time & resources to those areas of greatest reward – with the ultimate goal of achieving company-wide improvements based on the identification of individual findings/observations. Inspectional time management, therefore, is a key component for success and can be achieved most effectively through a risk-based approach using critical thinking. This webinar will provide practical inspection approaches that an investigator may apply throughout the product lifecycle, including R&D/development laboratories, for quick and effective identification of areas of concern, with the goal of achieving long-lasting system-wide improvements that ultimately lower costs and result in the production of a higher quality product.

We will discuss:

• Inspections of application data within R&D/development laboratories

• Inspecting microbiology

• Reviewing electronic data in unfamiliar QC systems

• How to identify triggers during a paper-based inspection

• Effective interview techniques

• Critical thinking during an inspection

• What are triggers and how do I identify them?

In addition, for those interested, this webinar offers an additional 30 minutes for Q&A upon completion of the presentation.

This 60-minute webinar will continue the discussion into risk-based inspectional techniques for manufacturing systems, and will conclude with a look into formulating comprehensive observation responses. Writing and responding to findings from the manufacturing system involves a unique approach due to the diverse and highly configurable nature of the electronic systems used in a typical GMP operation, and the ability to write and communicate clearly often determines the difference between accepting or rejecting a batch (or worse). By framing the situation through a quality risk management (QRM) lens focusing on patient safety, we are able to communicate more clearly with those who may not have participated in the inspection but will ultimately make the final decision regarding the need to address the issue (or not).

We will discuss:

• Case studies of previous significant regulatory actions (e.g. 483’s/Warning Letters)

• How to write meaningful and effective responses using Quality Risk Management (QRM) tools

In addition, for those interested, this webinar offers an additional 30 minutes for Q&A upon completion of the presentation.

This 60-minute webinar includes a discussion of advanced techniques for inspection of manufacturing systems. We will discuss specific inspectional approaches that provide risk-based oversight of complex and diverse manufacturing operations (APIs and drug products), from raw materials to the finished product. We will address how an investigator may approach inspection of an unfamiliar SCADA or other equipment control software, as well electronic batch records and notebooks. Inspection of the manufacturing system involves the ability to allocate limited time & resources to those areas of greatest reward – with the ultimate goal of achieving company-wide improvements based on the identification of individual findings/observations. Inspectional time management, therefore, is a key component for success, and can be achieved most effectively through a risk-based approach using critical thinking. This webinar will discuss practical inspection approaches that an investigator may apply for quick and effective identification of areas of concern, with the goal of achieving long-lasting system-wide improvements that ultimately lower costs and result in the production of a higher quality product.

We will discuss:

• Specific examples of how to perform a risk-based data review within an unfamiliar SCADA/DCS

• Risks when using electronic batch records and notebooks

• How to review data within a data historian

• How to identify triggers during a paper-based inspection

• Effective interview techniques

• Critical thinking during an inspection

• What are triggers and how do I identify them?

In addition, for those interested, this webinar offers an additional 30 minutes for Q&A upon completion of the presentation.