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196 books found — Page 3 of 7
Medical Devices.(Genzyme inspection highlights importance of verifying corrective and preventive action)(Brief Article): An article from: Validation Times
Medical Devices.(Genzyme inspection highlights importance o…
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Analysis of 483s/EIRs for GMP validation issues.(DPT Labs and Luitpold Pharmaceuticals go through investigations): An article from: Validation Times
Analysis of 483s/EIRs for GMP validation issues.(DPT Labs a…
By: Mark McCarty
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FDA, U.K.'s MCA can go own way on particle size, despite ISO guide.: An article from: Validation Times
FDA, U.K.'s MCA can go own way on particle size, despi…
By: Ken Reid
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Dust clouds Bioster's contract cervical dilator sterility validation.(Brief Article): An article from: Validation Times
Dust clouds Bioster's contract cervical dilator steril…
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EU GCP directive to go into force in May despite gaps in member states.(International)(good clinical practice)(European Union): An article from: Bioresearch Monitoring Alert
EU GCP directive to go into force in May despite gaps in me…
By: Tamra Sami
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HIPAA information security rules go live in 2005.(Health Insurance Portability and Accountability Act of 1996): An article from: Bioresearch Monitoring Alert
HIPAA information security rules go live in 2005.(Health In…
By: Gene Koprowski
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Quality of materials for supplements concerns executive.(Forouz Ertl)(Brief Article): An article from: Validation Times
Quality of materials for supplements concerns executive.(Fo…
By: Mark McCarty, Ken Reid
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IRB relies on hospital bylaws over FDA regulations, draws 483, warning letter. (IRBs).: An article from: Bioresearch Monitoring Alert
IRB relies on hospital bylaws over FDA regulations, draws 4…
By: Kelly Huegel
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Labs must deal with multiple contracts, making audits difficult.(Brief Article): An article from: Validation Times
Labs must deal with multiple contracts, making audits diffi…
By: Helen Lippman
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Data migration preferred to 'time capsuling;' FDA seen not knowing what to advise on legacy computers. (Legacy systems/Records maintenance).: An article from: Validation Times
Data migration preferred to 'time capsuling;' FDA…
By: A.E. Sadler
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Sunscreen maker cited for 'disregard' of GMPs.(Tanning Research Labs)(good manufacturing practices)(Brief Article)(Company Profile): An article from: Inspection Monitor
Sunscreen maker cited for 'disregard' of GMPs.(Ta…
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CSF shunt maker must revalidate sterilization, 510(k) commitment cited. (Medical Devices).(cerebrospinal fluid, Radionics/Tyco International): An article from: Inspection Monitor
CSF shunt maker must revalidate sterilization, 510(k) commi…
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Abbott slapped with 483, warning letter for process control, software, cleaning and sanitation violations.(Human drugs): An article from: Validation Times
Abbott slapped with 483, warning letter for process control…
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O'Farrell slapped with 13-item 483 for instrument calibration flaws; owner blasts agency.: An article from: Validation Times
O'Farrell slapped with 13-item 483 for instrument cali…
By: Joseph Pickett
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'Loop calibration,' based on measures, saves BASF money.(Brief Article): An article from: Validation Times
'Loop calibration,' based on measures, saves BASF…
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IVD exporter caught with 'cat in the bag,' as FDA warns firm about rodent control, QS deficiencies.(Medical devices): An article from: Validation Times
IVD exporter caught with 'cat in the bag,' as FDA…
By: Tamra Sami
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NIST program gives six-step process for maintaining calibration services.(National Institute of Standards and Technology)(Brief Article): An article from: Validation Times
NIST program gives six-step process for maintaining calibra…
By: Mark Karbarz
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FDA letting industry determine how to roll out RFID; validation, CBE requirements noted.(Counterfeiting/packaging): An article from: Validation Times
FDA letting industry determine how to roll out RFID; valida…
By: Gail Dutton
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Knowledge is first line of defense against Food and Drug Administration sanctions, experts advise.: An article from: Inspection Monitor
Knowledge is first line of defense against Food and Drug Ad…
By: Elizabeth Falcone
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Firm escapes 483 despite numerous issues.(GLPs, Taylor Technology): An article from: Bioresearch Monitoring Alert
Firm escapes 483 despite numerous issues.(GLPs, Taylor Tech…
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Analysis of 483s/EIRs for GMP validation issues.(Chemrich Holdings and Statson Pharmaceuticals environmental reports): An article from: Validation Times
Analysis of 483s/EIRs for GMP validation issues.(Chemrich H…
By: Mark McCarty
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CI fails to account for medical devices, maintain IRB approval.(Clinical investigators)(Orthopedic Specialties of Tampa Bay): An article from: Bioresearch Monitoring Alert
CI fails to account for medical devices, maintain IRB appro…
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INSPECTION LOG.(Freedom of Information Log investigation report)(Brief Article): An article from: Inspection Monitor
INSPECTION LOG.(Freedom of Information Log investigation re…
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P&U N.J. plant cited for HEPA, HVAC problems. (Blood/Biologics).: An article from: Validation Times
P&U N.J. plant cited for HEPA, HVAC problems. (Blood/Bi…
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Biotech fuels CRO growth, contracting newsletter reports.(contract research organizations)(Brief Article)(Statistical Data Included): An article from: Bioresearch Monitoring Alert
Biotech fuels CRO growth, contracting newsletter reports.(c…
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FDA enforcement comes full circle; risk-based auditing, fewer warnings eyed: Reagan-era approach replaces 'Kessler Era'.: An article from: Inspection Monitor
FDA enforcement comes full circle; risk-based auditing, few…
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INSPECTION LOG.(Brief Article): An article from: Inspection Monitor
INSPECTION LOG.(Brief Article): An article from: Inspection…
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INSPECTION LOG.(Brief Article): An article from: Inspection Monitor
INSPECTION LOG.(Brief Article): An article from: Inspection…
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INSPECTION LOG.: An article from: Inspection Monitor
INSPECTION LOG.: An article from: Inspection Monitor
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INSPECTION LOG.(inspection documents requested under Freedom of Information Act)(Brief Article): An article from: Inspection Monitor
INSPECTION LOG.(inspection documents requested under Freedo…
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Swedish company hit for media fill qualification's 'worst-case' validation.(Perstorp Pharma)(Brief Article): An article from: Validation Times
Swedish company hit for media fill qualification's �…
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Drug GMPs may be issued again as draft document.(good manufacturing practices)(Brief Article): An article from: Validation Times
Drug GMPs may be issued again as draft document.(good manuf…
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