Pharmaceutical Manufacturing Batch Record Review -  Webinar By GlobalCompliancePanel

Pharmaceutical Manufacturing Batch Record Review - Webinar By GlobalCompliancePanel


  • General Ticket

    Sale Date Ended

    INR 13347
    Sold Out

Invite friends

Contact Us

Page Views : 74

About The Event

Overview: The FDA and its European counterpart, EMA, require drug manufacturers to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. 

An efficient and effective batch record review process provides pharmaceutical companies with two strategies. First, this effort is key to maintaining control of your firm's manufacturing operations, eliminating any guesswork and aiding in the resolution of atypical occurrences. And, it enables a company’s to maintain and demonstrate a compliant posture, a sure way to avoid any quandary with regulatory agencies. Certain elements, practices and procedures are crucial to such an efficient and effective review process. As well, such logistics can only be put in place through an proactive training regime and review management system. This webinar will analyze each of these necessary elements of the batch record review process. 

Why you should attend:
  • Recognize regulatory (FDA/EU) requirements for batch records and batch record review
  • Modeling best practices of a technical review of batch records
  • Discover the essentials of batch record reviewer qualifications and training
  • Acquire confidence in determining the final decision or recommendations.
  • Establish a working relationship between production and quality reviewers
  • What to do when a batch fails to meet specifications (discrepancies)

Areas Covered in the Session:
  • Regulatory requirements for batch record review
  • Skills and responsibilities of an effective batch record reviewer 
  • Tools for effective batch record review 
  • Production and Quality reviewers 
  • Training plan for batch record reviewers

Who Will Benefit:
  • Quality assurance batch record reviewers
  • Production personnel who are responsible for batch record entries and reviews

NetZealous LLC,DBA GlobalCompliancePanel 

161 Mission Falls Lane,Suite 216, Fremont, CA 94539, USA         

USA Phone:800-447-9407

Fax: 302-288-6884