ComplianceOnline

Best Documentation Practices for FDA Compliance

Instructor: Nick Campbell
Product ID: 701774
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Nov-2013

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will discuss the best practices for documentation for FDA regulated companies. You will learn techniques and ideas that will help you identify effective methods to improve your document control systems.

Why Should You Attend:

  • Do your reports completely explain the relevant issues?
  • Are your SOPs accurate, relevant, and useful to your operators?
  • Do your employees maintain proper control over your documentation systems?

A successful documentation system ensures that no items are left open and unresolved. This webinar will teach specific techniques to ensure organizations are in compliance with regulatory guidelines concerning documentation. We will focus on how to standardize your documentation so that every report or record is handled the same way. Further, you will learn techniques that will help you create solid procedures that are unambiguous and complete. We will also examine applicable warning letters and 483s so that your company doesn't make the same mistakes as other organizations. By building compliance into every aspect of your operation, you can concentrate on getting more quality product out the door.

Areas Covered in the Webinar:

  • The basis for complete documentation.
  • The most likely areas for scrutiny.
  • Establishing effective procedures that will pass inspections with ease.
  • Defining adequate control measures to ensure compliance.
  • Determining proper review techniques for records and reports.
  • Rehearsing effectively for regulatory audits.
  • Developing an SOP for generation and maintenance of documentation.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Manufacturing and operations personnel
  • QA managers and personnel
  • Quality control personnel
  • Facility maintenance and calibration personnel
  • Logistics and supply personnel
  • Any employee involved in regulatory audits
  • Documentation department manager and staff
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Documentation department
  • Consultants

Instructor Profile:

Nick Campbell, has spent his 25-year career working in operations for highly regulated industries, including the 20 years in the nuclear power, pharmaceutical, medical device, and biotechnology sectors. His skills include a high level of proficiency in process engineering and facility operations. He has been instrumental in numerous regulatory audits including FDA, European Union, and Health Canada.

Follow us :
Validation, Verification and Transfer of Analytical Methods
Upcoming In-person Seminars by EX-FDA OFFICIALS

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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