News by Tag: Pharmaceutical Training
RAPS pre-approved webinar on "Batch Production Record and Device History Record Review and Quality Assessment"
March 21, 2013
The fundamental reason for issuance of 483, Warning Letters and Consent Decrees from the FDA in the areas of injectables, devices and solid dosagesis faulty technical documentation of the production processes.
March 21, 2013
The fundamental reason for issuance of 483, Warning Letters and Consent Decrees from the FDA in the areas of injectables, devices and solid dosagesis faulty technical documentation of the production processes.
RAPS pre-approved webinar on "510(K): Format and Contents" from GlobalCompliancePanel
March 21, 2013
A 510 (K) premarket notification is the most common route to the market for a medical device, including in-vitro diagnostics (IVD's).
March 21, 2013
A 510 (K) premarket notification is the most common route to the market for a medical device, including in-vitro diagnostics (IVD's).
RAPS pre-approved webinar on
March 21, 2013
The ICH Q-10 guidelines, which have been in force since 2006, have specific instructions for application of drug operations.
March 21, 2013
The ICH Q-10 guidelines, which have been in force since 2006, have specific instructions for application of drug operations.
GlobalCompliancePanel to conduct RAPS pre-approved webinar on
March 21, 2013
Ask any regulatory professional which the most agonizing moment of her life is, and the answer is almost certain to be,"FDA inspections"
March 21, 2013
Ask any regulatory professional which the most agonizing moment of her life is, and the answer is almost certain to be,"FDA inspections"
RAPS pre-approved webinar on "New EU Pharmacovigilance Directive and Regulations" from GlobalCompliancePanel
March 21, 2013
Starting July 2012, changes governing Good Pharmacovigilance Practices (GVP) brought about by the EU started kicking in. The EU is writing a series of Guidance Documents to assist in the implementation of GVP with all stakeholders such as sponsors, a
March 21, 2013
Starting July 2012, changes governing Good Pharmacovigilance Practices (GVP) brought about by the EU started kicking in. The EU is writing a series of Guidance Documents to assist in the implementation of GVP with all stakeholders such as sponsors, a
RAPS pre-approved webinar on "Statistics for Quality Control and Process Validation: Statistical Process Control (SPC) for Attribu
March 21, 2013
A test method or manufacturing process does not end with validation. There is a continuing need to demonstrate that the procedure continues to operate consistently and reproducibly in a manner that meets the validation requirements.
March 21, 2013
A test method or manufacturing process does not end with validation. There is a continuing need to demonstrate that the procedure continues to operate consistently and reproducibly in a manner that meets the validation requirements.
Webinar on "Statistics for Quality Control and Process Validation: Statistical Process Control (SPC) for Variable data"
March 21, 2013
Validation is not where atest method or manufacturing process ends. After this has been done, there is a need to continuously demonstrate that the procedure will operate consistently and reproducibly in a manner that meets the validation requirements
March 21, 2013
Validation is not where atest method or manufacturing process ends. After this has been done, there is a need to continuously demonstrate that the procedure will operate consistently and reproducibly in a manner that meets the validation requirements
RAPS pre-approved webinar on
March 21, 2013
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinaron April 9, 2013.Kim Huynh-Ba, Executive Director of Pharmalytik will be the Speaker at this session.
March 21, 2013
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinaron April 9, 2013.Kim Huynh-Ba, Executive Director of Pharmalytik will be the Speaker at this session.
RAPS pre-approved webinar on
February 26, 2013
Policy/procedures, adequate training for execution and compliant/complete documentation are the three basic elements of a validation program.
February 26, 2013
Policy/procedures, adequate training for execution and compliant/complete documentation are the three basic elements of a validation program.
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR) -The Requi
February 26, 2013
Products made in the US have to meet global product design documentation specifications.
February 26, 2013
Products made in the US have to meet global product design documentation specifications.
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