Good Documentation Practices: What Helps Make Your Controlled Documents Compliant

Duration: 90 Minutes
While there is no official requirement for "good documentation practices" it is a "current" industry practice that is reviewed and cited by federal regulators, corporate and third party auditors when audited. Since legal and controlled documents are subject to the recording of information and the signing and dating of such information by the person responsible, good documentation practices are expected to assure they are accurate, legible and traceable to name a few. It is well known that the FDA considers anything that is not properly documented to have never occurred, but how you document results is just as important. In addition, the lack of such good practices is routinely cited in FDA 483 observations, yet they should be some of the very first and basic topics covered during employee training.
Document Compliance
Instructor: Kenneth Christie
Product ID: 500816

Why Should you Attend:
This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. During audits, poor documentation practices that are found and not corrected are often considered to be an example of the quality unit not fulfilling their responsibilities for review of such documents. This webinar will help attendees review their own procedures and what should be included in applicable training sessions. The topics that are covered are important for activities ranging from the review of qualification protocols, to the recording of information found in batch records and beyond.

Objectives of the Presentation:
The objectives of the presentation are to learn about:
  • What is the definition of good documentation practices?
  • Review of examples of good documentation practices and what they apply to
  • Examples of documentation practices that should be avoided
  • Review of practices for correcting mistakes or when space is limited for comments
  • Review of FDA 483 citations give to companies
Who can Benefit:
  • Manufacturing...how it impacts the recording of manufacturing actions and results
  • Validation...as it impacts the recording of test data results
  • Quality Unit...as it impacts all controlled documents that are reviewed and approved.
  • Regulatory...knowing what to look for in official documents submitted to the agency.
  • Engineering...knowing what to record and practices to avoid
  • Vendors
  • Management
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Prior to joining VTS, Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility in Rochester, MI. While there, he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. Additional responsibilities included routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.
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