Analytical method validation:

• 9/07

• 2/07

• February 2001 Validation of Analytical Methods

Analytical methods:

• 8/13

• 7/13

• 5/12

• 11/11

• 10/11

• 9/11

• 1/08

• 7/06

• 6/06

• 2/05

• 8/04

• January 2001 Specificity of Analytical Methods

Analytical methods – TOC:

• 5/12

• 10/07

• 9/07

• 12/04

• 6/04

• 5/04

• 4/04

• 11/03

• 8/03

API manufacture:

• 1/17

• 6/16

• 5/16

• 4/16

• 12/07

Biotech issues:

• 6/09

• 9/08

• 4/07

• 3/07

• 6/05

• 5/03

Campaigns:

• 5/12

• 1/11

• 6/07

• 11/00

Clean Hold Time:

• 4/17

• 6/12

• 2/12

• 4/08

• 1/07

• 9/06

• 3/06

• 2/06

• November 2001 Cleaned Equipment Hold Time

Cleaning agents:

• 5/12

• 12/09

• 6/09

• 4/08

• 9/05

• 8/05

Cleaning procedure:

• 9/16

• 1/16

• 11/15

• 12/10

• 8/06

• 1/05

Cleaning verification:

• 4/12

• 2/10

• 11/09

• 8/08

• 1/08

• April 2001 Cleaning for Manufacture of Clinical Trial Materials (CTMs)

Clinical trials:

• May 2001 Setting "Dose" Limits Without Dosing Information

• April 2001 Cleaning for Manufacture of Clinical Trial Materials (CTMs)

Continuous manufacture:

• 4/14

Dedicated equipment:

• 5/12

• 1/06

• November 2000 Campaigns and Dedicated Equipment

Design/development of cleaning processes:

• 12/14

• 9/09

• 8/06

• 1/05

Dirty Hold Time:

• 4/17

• 2/12

• 12/06

• 1/03

• October 2001 Dirty Equipment Hold Times

Endotoxin issues:

• 2/04

GRAS:

• 7/15

Grouping – Equipment:

• 6/14

• 11/12

• August 2001 Equipment Grouping Strategies for Cleaning Validation

Grouping – Product: 

• 10/04

• July 2001 Product Grouping Strategies for Cleaning Validation

Highly Hazardous Actives:

• 2/15

• 6/12

History (of cleaning validation):

• 2/08

Indirect product contact surfaces:

• 10/14

• 9/14

• 8/14

• October 2000 The Applicability of Cleaning Validation

Limits (general):

• 12/16

• 11/16

• 7/16

• 3/13

• 10/12

• 9/12

• 11/11

• 10/11

• 9/11

• 4/11

• 5/09

• 3/09

• 11/08

• 10/08

• 1/08

• 12/07

• 1/06

• 6/05

• March 2002 What's a Contaminant?

• February 2002 The Use of Default Limits

• January 2002 The Use of Safety Factors in Limits Calculations

Limits – actives:

• 10/16

• 6/03

• December 2001 What's a "Dose" for Calculating Limits?

• May 2001 Setting "Dose" Limits Without Dosing Information

Limits – ADE:

• “Risk-MaPP”

• “Limits – health-based”

Limits – PDE:

• “Limits – health-based”

Limits – bioburden:

• 2/07

• 5/05

Limits – biotech:

• 3/17

• 2/17

• 4/07

• 3/07

Limits – cleaning agents:

• 1/14

• 11/07

• 9/05

• 8/05

Limits – health-based:

• 7/16

• 3/16

• 9/15

• 8/15

• 5/15

• 4/15

• 3/15

• 5/14 addendum;

• 12/13

• 11/13

• 5/13

• 3/12

Limits – preferential transfer:

• 7/14

Limits – rinse sampling:

• 5/13

• 4/13

• 2/09

• 1/09

• 4/08

• 10/05

Limits – swab sampling:

• 11/05

Limits – stratified sampling:

• 5/10

• 4/10

• 3/10

Limits – TTC:

• 5/07

Lyophilizers:

• 10/14

• 9/14

• 8/14

Manual cleaning issues:

• 7/11

• 6/11

Master plans:

• 8/07

Media fills:

• 7/04

Medical devices:

• 7/05

• May 2002 Cleaning Validation for Medical Devices

Mock Soil/Soiling:

• 2/14

Monitoring:

• 8/13

• 7/13

• 1/04

Non-product contact surfaces:

• 6/08

• 5/08

• 10/06

Packaging (filling) equipment:

• 4/05

• 3/05

Parts washer:

• 1/12

PAT (continuous process verification):

• 11/09

• 10/03

Placebo cleaning:

• 9/16

Placebo sampling:

• 8/16

Process validation:

• 8/12

• 3/11

• 11/09

• 8/09

Protocol worst cases:

• 4/09

• July 2002 Worst-Case Process Conditions

Protocols:

• 2/16

• 3/11

• 8/08

• 3/06

• 3/04

• 7/03

Recovery (general):

• 6/10

• 9/08

• 4/08

• 7/07

• 6/04

• 2/03

• December 2002 Additional Considerations in Recovery Studies Part 2

• November 2002 Additional Considerations in Recovery Studies Part 1

• September 2001 Handling Sampling Recovery Results

Recovery – bioburden sampling:

• June 2002 Recovery Studies for Microbial Sampling?  

Recovery – rinse sampling:

• 10/13

• 1/13

• October 2002 Recovery Studies for Rinse Sampling

Recovery – solvent reflux sampling:

• 12/08

Recovery – swab sampling:

• 9/13

• 12/12

• 8/11

• 5/11

• 10/10

• 6/10

• 10/09

• 7/09

Recovery for volatiles:

• 5/14

Regulatory documents/issues:

• 6/15

• 3/11

• 12/10

• 8/09

• 7/08

• 3/08

• 1/05

• 7/03

• March 2001 The New FDA Compliance Program Guidance Manual and Cleaning Validation

Revalidation:

• 7/08

• 12/03

Risk MaPP:

• 2/13

• 10/12 addendum

• 3/12

• 12/11

• 7/11 addendum

• 2/11

• 11/10

• 5/09

• 10/08

Sampling:

• 5/05

• 4/04

• 4/03

Sampling – bioburden:

• 4/08

• 5/06

Sampling hold time:

• 2/12

Sampling – rinse:

• 10/15

• 12/09

• 2/09

• 1/09

• 4/06

• 11/05

• 11/04

• 9/03

• September 2002 Sampling the Sampling Rinse

Sampling – swab:

• 10/15

• 1/10

• 10/09

• 11/06

• 12/05

• 11/05

• 9/03

• 3/03

• August 2002 Selecting Swab Sampling Sites

SIP:

• 9/06

• 5/06

Solvents (organic):

• 11/07

Statistics:

• 7/10

• 6/10

• 11/05

• 4/03

Test Until Clean:

• 3/14

Topicals:

• 11/08

Unknown peaks:

• 2/05

Validation maintenance:

• 11/09

Visually clean:

• 12/15

• 1/15

• 9/10

• 8/10

• 7/10

• 9/04

• 3/03

• April 2002 Understanding and Applying "Visually Clean"

Water activity:

• 7/12

Water quality:

• June 2001 Water Quality for Validated Cleaning Processes

White rings (buffer tanks):

• 11/14