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Summary:

Where innovation meets sterile manufacturing

Document Control is one of the most critical aspects to meeting FDA compliance requirements. Last year, many FDA 483 violations were related to Records and Reports (23%; 21 CFR Part 11 Sub-part J).

However, it is easy to get lost when establishing a document control system or implementing an electronic document control system. How do you develop a process to effectively manage the creation, review, modification, issuance, distribution, and accessibility of all controlled documents?

This webinar will describe what a Document Control System is, why it's needed, what are the requirements for FDA regulated facilities, and how Berkshire Sterile Manufacturing (BSM) has established its own effective Document Control System.

Speaker:

Topics to be covered:

  • Definition of a Document Control System
  • 21 CFR Part 11 Subpart J – Records and Reports Compliance Requirements
  • The lifecycle of a document (how it’s drafted, revised, approved, executed, and reviewed) 
  • Tracking and documenting Batch Records, SOPs, and Test Methods
  • Ensuring control and traceability for issued copies 
  • How BSM maintains its documents onsite
    BSM’s Document Control Procedure 

Michelle Toro, ASQ CQA

BSM Associate Director, Quality Assurance

Michelle Toro, ASQ CQA

BSM Associate Director, Quality Assurance

Michelle Toro is a quality assurance professional with over 20 years of experience in the pharmaceutical industry. She has worked at several established pharmaceutical companies including, most recently, Teva Pharmaceuticals for 11 years. 

Currently, she is the Associate Director of Quality Assurance at Berkshire Sterile Manufacturing (BSM). She hosts both regulatory and customer audits as well as conducts audits for BSM and manages the company’s document control team and other quality systems

Thursday, December 10th, 2020 | 11:00AM - 12:00PM EST

11:00AM - 12:00PM EST

Thursday, December 10th, 2020

What you will learn:

  • What is a Document Control System?
  • Why is a Document Control System needed?
  • What are the requirements for FDA regulated facilities?
  • How has Berkshire Sterile Manufacturing established its own Document Control System?

Establishing an Effective

Document Control System 

for FDA Compliance

Establishing an Effective

Document Control System 

for FDA Compliance

Michelle Toro is a quality assurance professional with over 20 years of experience in the pharmaceutical industry. She has worked at several established pharmaceutical companies including, most recently, Teva Pharmaceuticals for 11 years. 

Currently, she is the Associate Director of Quality Assurance at Berkshire Sterile Manufacturing (BSM). She hosts both regulatory and customer audits as well as conducts audits for BSM and manages the company’s document control team and other quality systems

Speaker: