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Books by Joseph Pickett

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22 books found
FDA guidance on new OTC drug, supplement AE reporting law seen by September, audits to follow.: An article from: Inspection Monitor
FDA guidance on new OTC drug, supplement AE reporting law s…
By: Joseph Pickett
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Wyeth hit with 54-item 483 for OOS results, faulty aseptic results, HVAC.(Human drugs): An article from: Validation Times
Wyeth hit with 54-item 483 for OOS results, faulty aseptic …
By: Joseph Pickett
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FDA envisions slight drop in audits for biologics, drugs in FY '06; device inspections to stay even.: An article from: Inspection Monitor
FDA envisions slight drop in audits for biologics, drugs in…
By: Joseph Pickett
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Sterility problems and OOS stability results trip up Sanofi Pasteur.(Biologics): An article from: Validation Times
Sterility problems and OOS stability results trip up Sanofi…
By: Joseph Pickett
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12-item 483 for CI highlights examples of poor trial site oversight.(Clinical investigators): An article from: Bioresearch Monitoring Alert
12-item 483 for CI highlights examples of poor trial site o…
By: Joseph Pickett
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OOS results, media hold-time specifications, flawed validation reports net IDEC 10-item 483.(Biologics): An article from: Validation Times
OOS results, media hold-time specifications, flawed validat…
By: Joseph Pickett
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Biogen cited for cleaning/autoclave validation, faulty filter extractable studies.(Human drugs): An article from: Validation Times
Biogen cited for cleaning/autoclave validation, faulty filt…
By: Joseph Pickett
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Validation flaws and lack of instrument calibration net 9-item 483.(Human/animal drugs): An article from: Validation Times
Validation flaws and lack of instrument calibration net 9-i…
By: Joseph Pickett
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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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New guidance on inactives used in generics to be released.(Excipients): An article from: Validation Times
New guidance on inactives used in generics to be released.(…
By: Joseph Pickett
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23-item 483 issued to Advanced Bionics for quality audits, process validation and risk analysis faults.(Medical devices): An article from: Validation Times
23-item 483 issued to Advanced Bionics for quality audits, …
By: Joseph Pickett
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Mammalian cell technology improving, expert notes; 1-4g/L realized now, 5-10g/L expected soon.(Biotech): An article from: Validation Times
Mammalian cell technology improving, expert notes; 1-4g/L r…
By: Joseph Pickett
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FDA GMP inspections tend to focus on the '6 P's', says Novartis QA representative.(Special Report: Surviving FDA GMP Inspections): An article from: Inspection Monitor
FDA GMP inspections tend to focus on the '6 P's&#…
By: Joseph Pickett
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Validity of some MDS Pharma studies questioned by agency; pending NDAs could be delayed.(Compliance/enforcement): An article from: BioResearch Compliance Report
Validity of some MDS Pharma studies questioned by agency; p…
By: Joseph Pickett
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MDS Pharma Services slapped with 3-item 483 concerning contamination following bioequivalence audit.(CROs): An article from: Bioresearch Monitoring Alert
MDS Pharma Services slapped with 3-item 483 concerning cont…
By: Joseph Pickett
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Nine-item 483 for Positron for calibration and quality audit problems.(Medical devices): An article from: Validation Times
Nine-item 483 for Positron for calibration and quality audi…
By: Joseph Pickett
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Presence of particulate matter in vials top reason for product recalls, Pfizer executive reports at PDA conference.(Recalls): An article from: Validation Times
Presence of particulate matter in vials top reason for prod…
By: Joseph Pickett
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Clinical trials must be registered if research is funded by pharma industry.(Registeries): An article from: BioResearch Compliance Report
Clinical trials must be registered if research is funded by…
By: Joseph Pickett
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Andrx Pharma on receiving end of 9-item 483 for OOS, QC violations, control procedures.: An article from: Validation Times
Andrx Pharma on receiving end of 9-item 483 for OOS, QC vio…
By: Joseph Pickett
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FDA gives pharma companies regulatory relief as they implement PAT.(Process analytical technology): An article from: Validation Times
FDA gives pharma companies regulatory relief as they implem…
By: Joseph Pickett
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Big pharma to begin rollout of SAFE electronic sig system in 2007.(Electronic records): An article from: Validation Times
Big pharma to begin rollout of SAFE electronic sig system i…
By: Joseph Pickett
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Part 11 rears its head in Draxis Pharma 3-item 483.(Human drugs): An article from: Validation Times
Part 11 rears its head in Draxis Pharma 3-item 483.(Human d…
By: Joseph Pickett
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