Good Manufacturing Practices Training
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based in USA
This Pharma GMP courseware covers all aspects of good manufacturing practices starting from difference between GLP and GMP, vendor selection, supplier agreements & management, raw material risk management, HVAC, GMP environmental control, pharma compressed air, annual product reviews ,deviation investigations, human error reduction ...
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PremiumManufactured by Particle Measuring Systems (PMS)based in USA
On December 20th, 2017, the draft for a Revision of ANNEX 1 (“Manufacture of Sterile Medicinal Products”) of the EU Guideline for GOOD MANUFACTURING PRACTICE for drug products and drug substances was published. This updated guidline will set a milestone for adjustments needed within European agencies overseeing drug ...
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based in USA
authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA. The seminar will discuss in detail the: • Types of inspections done by US FDA, EMA and PMDA • Typical Audit Agenda that can be expected by each Authority • Scope of Audits.........how many auditors, how ...
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based in USA
This comprehensive FDA inspection training package consists of five training webinar recordings covering everything from preparing for FDA inspections to responding to FDA Form 483s and warning letters. Are you sure you're prepared for an FDA inspection in the new future? Do you think your personnel have received enough training to properly get through an FDA inspection? To help FDA regulated ...
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based in USA
This package of 5 training courses is meant to give an exhaustive and in-depth understanding of the Japanese Pharmaceutical Affairs Law (PAL) including the 2005 revisions which are now in ...
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based in USA
Conducting clinical trials in a rapidly evolving electronic environment presents a unique challenge to the medical device industry where not only quality (GLP/GMP) plays an essential role – but collecting accurate, maintaining viable data (GCP) as part of continuous process improvement (while mitigating risk) is an essential and critical component of the development paradigm. The complexity ...
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based in USA
The following is a pack of 3 best-selling training CDs for regulatory professionals in the Medical Device industry. These courses provide information on how medical device companies can achieve compliance with the EU Medical Device Directive, obtain CE marking and fulfill ISO ...
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based in USA
This comprehensive training package of 7 courses is aimed at helping companies to be compliant and streamline the robust supply chain planning, processes, risk management etc by maintaining regulatory guidelines. Implementing Robust Supply chains for life-sciences companies are important now and growing in importance as device ...
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