Upcoming Pharma and biotech webinars/training

May 26, 2009

Check Pharma and Biotech webinars

Compliant GCP (Good Clinical Practice) Studies – Working with a CRO

Learn here

  • Steps to meet the sponsors requirements.
  • How to know – are GCPs being followed and is it documented.
  • Know the “relationships” – QA, Clinical and the CRO.
  • The Audit (aspects and specifics).
  • How to do an audit follow-up.
  • Post CRO Assessment – How

Objectionable Microorganisms: Considering the Risk

Learn here

  • What is an Objectionable Microbe?
  • Pathogens vs. Objectionables.
  • Just how objectionable is it?
  • Consider the risk.
  • Performing a risk assessment.

Advanced Topics in Good Documentation for GXPs

Learn here

  • The documentation practices that enhance study integrity, repeatability.
  • How to prevent 483 items related to data documentation.
  • The main documentation errors seen and cited by the FDA.
  • Why GLP serves as a good foundation for clinical studies, GMP, and even research.
  • Tips for documentation in lab notebooks.

Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

Learn here

  • Undertanding Japanese culture in context of JPAL.
  • Risk adversity in the MHLW, PMDA and filtering down to the MAH.
  • Language: Translations, interpretations and resulting gaps.
  • Technical differences – How to respond and persevere.
  • Culture differences – Sometimes we just have to go along.
  • Submission data – Best practices for common understanding.

Basics of testing associated with sterilization validation and routine processing

Learn here

  • What are the appropriate types of tests during sterilization validation.
  • What standards should be used for the testing.
  • What type of samples and sample sizes should be used.
  • What testing needs to be performed routinely.
  • What frequency of testing is recommended.
  • What methods can be used to reduce testing.

Source: ComplianceOnline


Upcoming Pharmaceutical webinars

August 12, 2008

Here are the good number of Pharmaceutical related webinars:

  1. Technology Transfer of a Pharmaceutical Manufacturing Process
  2. Organization of Clinical Datasets in eCTD Submissions
  3. Designing an Effective Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device Cleanrooms
  4. Ensuring Good Clinical Practice
  5. Pharma Sales Force Effectiveness: Increasing Productivity Through Streamlined Internal Communication
  6. Integrating Quality into Business Systems for High Performance
  7. Principles of Sterile Manufacturing
  8. Getting the Most Out Of Data Mining for Pharmacovigilance and Risk Management
  9. Transforming Pharmaceutical Sales and Marketing through Offshore Business Intelligence (BI) Services
  10. High Performance in Pharmaceutical R&D
  11. Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies
  12. Online Training for Laboratory Compliance- Pack of two courses