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Client Services

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On-Site Training

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Validation Practices

Curriculum Vitae

Ethics Statement

More on Limits Based on Compendial Water Values

The 500 ppb TOC Myth

Using Safety Factors of Less than 0.001 of a Dose

Does Risk-MaPP Offer More Patient Protection?

Recovery Studies for Different Surfaces for Rinse Sampling

Grouping for Surfaces for Swab Recovery Studies?

Selecting the Number of Validation Runs for Equipment Grouping

Another Critique of Risk-MaPP

Revisiting Limits Based on Process Capability

My Revised Shorthand for Expressing Limits

Differences between Cleaning and Process Validation

Significance of Water Activity for Cleaning Validation

Regulatory Guidances I’d Like to See Changed – Part 2

Regulatory Guidances I’d Like to See Changed – Part 1

How to Completely Avoid Doing Cleaning Validation

How Are ADE’s Determined for Non-Highly Hazardous Actives?

Hold Time Issues

Issues in Cleaning Validation for Parts Washers

The Good, the Bad and the Inexplicable of Risk-MaPP

Limits Below the LOD in Rinse Solutions – Part III

Limits Below the LOD in Rinse Solutions – Part II

Limits Below the LOD in Rinse Solutions – Part I

More on an Alternative Swab Recovery Procedure

Manual Cleaning Issues – Part 2

Where Risk-MaPP Got It Wrong

Manual Cleaning Issues – Part 1

An Alternative Swab Recovery Procedure

A Conundrum Regarding Limits

What Does the FDA Process Validation Guidance Say about the Number of Qualification Runs

More on ISPE’s RiskMaPP

More on Campaign Length

Understanding the Cleaning Process in 2010 (and Beyond)

A Critique of Cleaning Validation Issues in ISPE’s RiskMaPP

Swab Sampling Recovery as a Function of Residue Level

More Uses for Visual Limit Determination

Visually Clean and Visual Limits

Statistics for Visual Limits

Acceptable Variability for Sampling Recovery Studies

Final Notes on “Stratified Sampling”

More on “Stratified Sampling”

Basics of “Stratified Sampling”

Revisiting “Cleaning Verification”

What’s an “Equivalent” Swab?

The Rationale for Rinse Sampling for Cleaning Agents

“Continued” vs. “Continuous” Process Verification

Use of Multiple Swabs for Sampling

“Design Space” for Cleaning Processes

The Changing Paradigm for Cleaning Validations

Revisiting Linearity of Swab Recovery Results

Use of Alkali/Acid Cleaning Agents in Biotech

The Science Behind Limits

What’s Happening to Worst-case Process Conditions?

Differing Ways to Express Limits

Another Alternative for Rinse Sampling Limits

Limits for Rinse “Grab” Samples

Solvent Reflux Sampling Recovery

Limits for Topicals

Are We Setting Limits Correctly?

Sampling Recovery for Biotech

Do Three Verifications Make a Validation?

What’s Happening to Revalidation?

Still More on Floors and Walls

More on Floors and Walls

What Have We Learned in the Last Two Decades?

Canada’s Revised Guidelines

A Stroll Down Memory Lane

Can Protocols Use Limit Tests?

More on Limits for API Manufacture

Measuring Residues of Volatile Solvents?

Downsides to TOC?

TOC Analytical Method Validation

Master Plans vs. Policies

Spiking Amounts for Sampling Recovery Studies

Issues in Campaigns

Revisiting Medically Safe Limits

Limits for Bulk Biotech Manufacture – Part 2

Limits for Bulk Biotech Manufacture – Part 1

Microbiological Test Method Validation?

Dealing with Deviations in the CEHT

Dealing with Deviations in the DEHT

Use of Sampling Templates

CV for General Room Surfaces?

CEHT for Sterilized Equipment

Surface Roughness and Cleaning

FTIR with Fiberoptic Sampling

Ion Mobility Spectrometry

Measuring Bioburden in Protocols

More on Using Rinse Sampling Alone

Separating CEHT Protocols from Cleaning Protocols

Bioburden Proliferation in CEHT Protocols

Acceptance Criteria for Dedicated Equipment

Selecting the Swab Sampling Area

Averaging Swab Sample Results?

Limits for Rinse “Grab” Samples

More on Limits for Formulated Cleaning Agents

Issues in Limits for Formulated Cleaning Agents

Revisiting Cleaning Validation for Medical Devices

Setting Limits Based on Process Capability?

Objectionable Microorganism Concept in Cleaning Validation

Cleaning Validation for Packaging Equipment: Part 2

Cleaning Validation for Packaging Equipment: Part 1

Dealing with Unknown Peaks

Understanding the Cleaning Process

Establishing Adequate Solubility for TOC Analysis

Is Rinse Sampling Alone Acceptable?

Selecting Worst-Case Products for Grouping

Issues in the Visual Examination of Equipment Surfaces

More on Specificity of Analytical Methods

Cleaning After a Media Fill

TOC Issues: Part 3 – Blanks for Recovery Studies

TOC Issues: Part 2 - Appropriate Blanks

TOC Issues: Part 1 - Sampling Materials

Defining Three “Consecutive” Runs

Endotoxin Issues in Cleaning Validation

Monitoring a Validated Cleaning Process

Correlation of TOC with a Specific Analytical Method?

PAT and Cleaning Validation

Correlation of Swab and Rinse Sample Results?

Why TOC is Acceptable

Adequate “Documented Evidence” for Cleaning Validation

Limits for Drugs with Multiple Actives

What’s Really Different About Biotech?

Using Statistics in Sampling?

Is a Dirty Swab a “Visually Clean” Failure?

Using Sampling Recovery Percentages

More on DEHT Issues

Additional Considerations in Recovery Studies Part 2

Additional Considerations in Recovery Studies Part 1

Recovery Studies for Rinse Sampling

Sampling the Sampling Rinse

Selecting Swab Sampling Sites

Worst-case Process Conditions

Recovery Studies for Microbial Sampling?

Cleaning Validation for Medical Devices

Understanding and Applying “Visually Clean”

What’s a Contaminant?

The Use of Default Limits

The Use of Safety Factors in Limits Calculations

What’s a “Dose” for Calculating Limits?

Cleaned Equipment Hold Time

Dirty Equipment Hold Times

Handling Sampling Recovery Results

Equipment Grouping Strategies for Cleaning Validation

Product Grouping Strategies for Cleaning Validation

Water Quality for Validated Cleaning Processes

Setting “Dose” Limits without Dosing Information

Cleaning for Manufacture of Clinical Trial Materials (CTMs)

The New FDA Compliance Program Guidance Manual and Cleaning Validation

Validation of Analytical Methods

Specificity of Analytical Methods

Campaigns and Dedicated Equipment

The Applicability of Cleaning Validation

Specific Documents

Human Drug CGMP

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Expand Supplier Sites

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2nd Quarter 2001

1st Quarter 2002

Cleaning Agents

Coupons for Recovery Studies

Flexible Fiberoptic Scopes

High Pressure Equipment Cleaning Systems

In-line UV for Cleaning Monitoring

Microbial Identification Labs

Sampling Accessories

Tank or Bin Liners

TOC Instruments

Ultrasonics: Consoles for Parts Washing

Ultrasonics: Immersible Transducers for Tank Cleaning

Vials for TOC sampling

Cleaning Memo pdf

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Training Material

Residue Software

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Evaluation Copy

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Quality Assurance Documents $400.00
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