ISO 19011:2011-Guidelines for Auditing Management Systems to Conducting Effective Internal Audits

Duration: 90 Minutes
This webinar will utilize ISO 19011:2011, ICH Q10 and FDA guidances and explain how to conduct an effective internal audit program. Attendees will learn the benefits of a well-designed and executed internal auditing program, an overview of various cGMP regulations and how to reinforce their quality system, along with potential efficiency enhancements.
ISO 19011:2011
Instructor: Larry Stevens
Product ID: 505127
Due to the growing importance of regulatory compliance, the increasing international harmonization, and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal audits to find and correct areas where the facility is not in full compliance with the cGMP regulations. This allows corrections before a regulatory body audit.

Objectives of the Presentation
  • The need, purpose, cost and benefits
  • Principles of auditing
  • Establishing, Implementing and managing a quality audit program
  • The audit cycle - initiating, preparing, conducting, reporting, the wrap up, and follow up
  • Auditor competence evaluation - practice, behavior, knowledge and skills
  • Auditor evaluation - criteria, evaluation methods, improving
Why Should you Attend
Pharmaceutical and medical device companies are legally bound to ensure that regulated quality compliance standards are consistently maintained, with potentially severe business and legal consequences for certain failures. Regular internal audits are the best practice to meet and maintain compliance in changing manufacturing and regulatory environment before a potential critical discovery by an FDA audit. This is also a smart practice to improve efficiencies, especially during a product life-cycle.

This webinar will review this process and discuss best practices of an effective internal auditing program, and how to add overall value to the company.

Areas Covered
  • Regulatory expectations and rights
  • Expectations and benefits of good program and auditing
  • How to design and conduct an objective and effective audit
  • Auditing of business structure, facilities, personnel, records, laboratories, environment and validation
  • Effective management interaction and communication
  • The report and follow-up
Who will Benefit
This is especially important to regulated and / or quality critical product development companies such as pharmaceutical and medical device companies
  • Quality Assurance/Auditors - Program overview; initiating, preparing for, conducting, reporting, closing, cycle
  • Supervisors - Preparing for, participating in, responding to an audit
  • Managers - Preparing for, participating in, responding to an audit
  • Directors - Preparing for, participating in, responding to an audit
  • VPs of Product Development, Manufacturing or Quality
This is especially important to regulated and / or quality critical product development companies such as pharmaceutical, biopharmaceutical and medical device manufacturing plants in the U.S., or shipping product for sale in the U.S.

Topic Background
Compliance to an effective quality management system is both a critical regulatory requirement and is an expectation in doing business, without which a company can be shut down due to noncompliance or may fail due a poor reputation in the marketing of its products. Ensuring that compliance, quality and efficiencies are maintained, an effective internal auditing program are recommended, with regulatory guidances describing suitable expectations. This includes those produced by the FDA, ICH and ISO regulatory bodies. These guidances and principles are discussed in this webinar examining a good and effective internal audit system to reinforce quality expectations and efficiencies.
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
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:
Larry Stevens is a pharmaceutical science consultant focusing on strategic product development, quality and regulatory compliance. This encompasses quality by design, gap and risk analysis, experimental analytics, and the development and validation of methods, processes and environments.

He has extensive experience working for both large and small pharma companies and successfully working with a wide range of product types. Product development accomplishments include the strategic design of controlled release suspensions and the first orally disintegrating tablet on the market. Other accomplishments include the development and validation of hundreds of analytical methods, along with instrument, software, process and cleaning validations, SOPs, and successful CMC submissions.

The author of numerous articles, an internationally recognized speaker and conference chair, and a recipient of the Alcon Laboratories research award, Larry now consults in strategic quality product and analytical development, successfully meeting needed regulatory compliance requirements.
View More