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Q

Q

Training & Consulting

• Virtual
• Classroom
• Online Learning

Q Laboratories Consulting, LLC, now offers Training & Consulting opportunities with our expert team of scientists & trained laboratory personnel. Divided into 3 areas, click on any of the list items below to learn more about what the offering entails.

Laboratory

  • General Science
  • Method Validation
  • Probiotic Testing
  • Legionella Testing
  • Results Interpretation
  • Rapid Microbiological Methods

Manufacturing

  • Organism Risk Assessment
  • Utilities Monitoring
  • Cleaning and Santitation
  • OOS/OOT Results
  • Microbial Risk Assessments
  • Hygienic Design
  • Utilities Validation and Monitoring

Quality, Regulatory & Audits

  • cGMP (current Good Manufacturing Practices)
  • Understanding Regulatory Requirements
  • Facility Audits
  • Vendor Audits

Training

Laboratory

virtual, on-site, or classroom (optional lab practical)

Class 1. Basic Microbiology – standalone or as a series; designed with the “non-microbiologist” in mind.

Accessible for those with no background in microbiology, as well as maintaining interest for younger microbiologists or those that need a refresher. Example content:

• Fundamentals
• Methods (USP <51>, <60>, <61>, <62>, etc. and general principles)
• Identifications and risk assessments (procedures and considerations)

Class 2. Basic Chemistry – standalone or as a series; designed with the “non-chemist” in mind.

Accessible for those with no background in chemistry, as well as maintaining interest for younger microbiologists or those that need a refresher. Example content:

• Fundamentals
• Techniques
• Special focus for nutrition label testing

virtual or classroom

Class 1. Drug Method Validation Standards and Best Practices – Designed for anyone involved in the development or manufacture of drug products.

The course will provide an overview of relevant USP guidance chapters (USP <1225>, USP <1227>, etc.), other relevant guidance documents, lessons from industry (common FDA observations), and general watchouts/best go-to-market strategies.

Class 2. Food Method Validation Standards and Best Practices – Designed for anyone involved in the development or manufacture of food products, or food testing methods.

The course will provide an overview of the AOAC and ISO method validation processes. The course will also provide an overview of ISO 16140 Part 3, and strategies for coming into compliance.

virtual, on-site, or classroom (optional lab practical)

Class 1. Enumeration Methods – Method basics, and explanation of inherent variability.

This course will provide an overview of “watch-outs” in probiotic development and launch. Can be standalone module, or “add-on” to “Basic Microbiology” course.

virtual, on-site, or classroom (optional lab practical)

Class 1. Legionella Test Methods – Designed with the “non-microbiologist” in mind, this course is specifically geared toward Water Treaters and others in the Water Treatment Industry.

This course will provide an overview of Legionella test methods including cultural (ISO 11731) and rapid method options (e.g., PCR, qPCR, LFICA, etc.), and considerations/best practices for each. Can be standalone module, or “add-on” to “Basic Microbiology” course.

Manufacturing

virtual, or classroom

Drugs and Personal Care Products “Objectionable Microorganisms” – This course is designed for Quality/Regulatory personnel, QC microbiologists, plant hygienists, and others involved in disposition decisions for drug and personal care products. This course will provide general considerations for assessing risk posed by contaminating microorganism(s), as well as “lessons learned” from industry based on FDA Warning Letters, recalls, etc. Can be standalone module, or “add-on” to “Basic Microbiology” course.

virtual, on-site, or classroom

  • HVAC – General best practices for design/installation/validation. Considerations for implementing a valuable environmental monitoring program, setting excursion limits, and appropriate response(s).
  • Compressed Air – General best practices for design/installation/validation. Considerations for impolementing a valuable compressed air monitoring program, setting excursion limits, and appropriate responses.
  • Water – General best practices for design/installation/validation. Considerations for implementing a valuable water monitoring program, setting excursion limits, and appropriate response(s).

virtual, on-site, or classroom

  • Cleaning – What is cleaning? This course will provide an overview of cleaning principles and provide general considerations and best practices for cleaning of various common product matrices. This course will also provide best practices for cleaning validation, ongoing verification, and re-validation.
  • Sanitization – What is sanitization? This course will provide an overview of sanitization principles (as separate and distinct from cleaning), and provide general considerations and best practices for sanitization. This course will also provide best practices for sanitization validation, ongoing verification, and re-validation.

Quality/Regulatory

virtual, on-site, or classroom 

  • General cGMP (introductory or refresher) – This course is designed to provide a general overview of cGMP (21 CFR Parts 210/211 and 11). The course will include a brief history of cGMP, and provide an overview of cGMP requirements as they pertain to drug manufacturing. It is designed to be suitable as a general introductory training, and/or to serve the purpose of ongoing refresher training as required by 21 CFR 211.25.
  • Client Specific cGMP Training – This training is developed to meet defined client needs/requests. It may be tailored to address precise outages/areas for improvement a client may have or may be based on findings from a GMP Audit/other regulatory finding. This is an opportunity to tailor the training very specifically put cGMP requirements into “real world” context for each employee.

virtual, on-site, or classroom

  • What regulatory bucket am I in? – This course is designed for those new to manufacturing, or those who may start manufacturing a new class of products (e.g., begin manufacturing drugs in addition to existing cosmetics products). The course will provide an overview of how different regulatory buckets are defined, and different requirements/best practices for each.

Consulting

Laboratory

virtual

  • Troubleshooting – what to do when results are not meeting expectations? Assistance with unit conversions/translation between supplier CoA(s), etc.
  • Impact Assessment – when you have an OOS/OOT result, you need to assess the risk to that lot/batch and have scientifically sound risk assessment to move forward. Q Labs can assist.

virtual (optional classroom component)

  • Evaluation – determining whether a rapid micro method is right for you, and if so, which one(s)? Interviews with the client will allow Q Labs to develop a report outlining potential rapid method options, rough cost estimates, pros/cons, etc. Q Labs can then recommend and execute a plan to evaluate rapid method options for potential adoption.
  • Adoption – Q Labs can help strategize adoption of a particular rapid method, and deploy it in your business. Q Labs can ensure you are complying with applicable standards during this process (e.g., ISO 16140 Part 3, USP <1223>, etc.).
  • ISO 16140 Part 3 – Q Labs can assist you with coming into compliance.

Manufacturing

virtual or on-site

  • OOS Investigation – We can assist with, or lead, an OOS Investigation consistent with FDA guidance and industry best practices.
  • Organism Risk Assessment – provide the client with a multifaceted assessment a recovered microorganism my present to their product and consumers. The assessment will provide information including but not limited to: survival potential, pathogenicity, risk of a consumer noticeable defect.

on-site

  • Microbial Risk Assessment – Holistic review of manufacturing design, processes, and procedures that may contribute microbial risk to product(s).

virtual and/or on-site

  • Proposed Design Review – Q Labs can review design plans (e.g., P&ID, etc.) and provide feedback on risks, opportunities for improvement, etc. This can be thought of as an MRA for proposed systems. Q Labs can also serve as the subject matter expert in discussions with vendors (e.g., architects, contractors, etc.) ad hoc or during routine design reviews during build-out.

Pre-Production Assessment – Q Labs can audit a system/facility prior to “acceptance” from the vendor and/or prior to beginning production to ensure the system was built/installed as represented/agreed to in the P&ID, etc. In the event of any discrepancy, Q Labs can provide advice on risk mitigation.

virtual and/or on-site

  • Cleaning – Q Labs can examine/troubleshoot existing cleaning procedures, and or assist with developing and validating new cleaning procedures (including protocols, reports, plans for re-validation/ongoing verification, etc.).
  • Sanitization – Q Labs can examine/troubleshoot existing sanitization procedures, and or assist with developing and validating new sanitization procedures including protocols, reports, plans for re-validation/ongoing verification, etc.).

Utilities Validation: Provide information and assistance regarding best practices for validating a critical utility systems. Provide recommendations and/or lead efforts for critical utility system validations, including generation and/or review of protocols, reports, SOPs, etc.

  • Heating, Ventilation and Air Conditioning (HVAC)
  • Compressed Air
  • Ingredient Water (e.g., USP Purified Water)

Utilities Monitoring: Provide information and assistance regarding best practices for design/implementation of ongoing monitoring program including generation and/or review of protocols, reports, SOPs, etc.

  • Environmental Air Monitoring (HVAC)
  • Compressed Air
  • Ingredient Water (e.g., USP Purified Water)

Audits

on-site

  • General Site Audit – Whether “for cause”, or as part of your general continuous improvement journey, Q Labs can serve as a neutral 3rd party to perform a General Compliance Audit. After the audit, Q Labs will provide a report of findings, along with recommended actions.
  • Mock FDA Audits – Unlike the General Site Audit, a Mock FDA Audit will be “unannounced” (scheduled only with representative managerial staff) to mimic the process, procedures (and anxiety) associated with an FDA Audit. This can be combined with FDA Audit readiness training. Just like the General Site Audit, Q Labs will provide a report of findings (including regulatory references), along with recommended actions.

on-site

  • General Compliance Audit – Q Labs can act on your behalf for routine audits of your suppliers, and contract manufacturing partners.
  • For Cause Audit – Q Labs can assist with or lead for-cause audits stemming from OOS/OOT results, complaints, etc.

Scientifically Accurate Results, Exceptional Customer Service


Q Laboratories has 55 years of experience helping our clients to ensure the quality and safety of their products. Our team of analysts, scientific consultants, and customer service representatives are ready to provide you with accurate results you can trust and understand. 

 

Whether your company is big or small, established or just getting started, contact us today and experience what Q can do for you!

Contact Q Laboratories For Training & Consulting

If you’re searching for training & consulting, search no further than Q Laboratories. Contact us online or call us at 513-471-1300 to learn more.

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