ComplianceOnline

Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists

Instructor: Daniel Norwood
Product ID: 705169
  • Duration: 90 Min

recorded version

$279.00
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: Apr-2017

Training CD

$379.00
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 on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process.

Why Should You Attend:

Major paradigm shifts in the pharmaceutical industry business model over the past decade have led to increased emphasis on drug discovery with a proportionate decreased emphasis on development activities for many large pharmaceutical companies. In addition, the number of smaller “start-up” companies, particularly in the biopharmaceutical area, has significantly increased. These smaller companies often have limited resources for development activities, and along with larger companies with reduced internal resources allocated for development, have turned to outsourcing as a way to maintain full development capacity. Of the various pharmaceutical development activities and work packages, those involving analytical testing are prime candidates for outsourcing.

Selection and qualification of contract laboratories (i.e., contract research organizations; CROs) often falls to pharmaceutical scientists within a given organization. Many pharmaceutical scientists are not trained in best industry practices for either task and rely on internal procurement and quality organizations for guidance.

This webinar is designed to assist pharmaceutical scientists who have been given responsibility for the outsourcing of analytical testing activities related to pharmaceutical development. Topics covered will include: criteria for CRO selection, basic principles of quality (i.e., GXP) auditing and qualification of a CRO, technical qualification of a CRO, business proposals and study protocol development, and management of on-going projects at CROs. This webinar is intended to build the confidence of pharmaceutical scientists in their ability to be successful in the growing field of outsourcing management.

Learning Objectives:

Upon completing this webinar, participants should:

  • Understand the process of CRO selection for analytical testing
  • Gain knowledge of the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process
  • Understand the development of business proposals, quotations, quality agreements and study protocols
  • Understand the process of technical qualification of a CRO
  • Be comfortable with the process of management of CRO activities
  • Be familiar with best practices for the reporting of CRO results and the incorporation of CRO reports into regulatory submissions

Areas Covered in the Webinar:

This webinar will begin with a brief discussion of outsourcing trends in the pharmaceutical industry with a focus on the outsourcing of analytical chemistry sample analysis and other analytical development work packages. Continuing discussions will focus on:

  • The CRO selection process, based on the nature of individual work packages
  • Quality auditing of a CRO, assuming that the audit is led by a pharmaceutical scientist
  • Technical evaluation of a CRO
  • Preparing and evaluating requests for proposals
  • Developing study protocols
  • Best practices for CRO management, micromanagement versus hands-off
  • Working with a CRO to create reports for regulatory submission

The webinar section on CRO quality auditing will present case examples of audit proposals and schedules, audit checklists, and audit reports. Case examples will also be presented in support of the sections on CRO selection, development of study protocols, CRO management and mismanagement, and CRO reports for regulatory submission.

Who Will Benefit:

This webinar is designed for pharmaceutical scientists who have been given responsibility for the outsourcing of analytical testing activities related to pharmaceutical development. This includes individuals who have no experience with pharmaceutical outsourcing as well as those who may have some experience but wish to enhance their knowledge. The following personnel will benefit from the course:

  • Pharmaceutical scientists
  • Analytical chemistry professionals
  • Pharmaceutical development managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Quality auditors
  • Pharmaceutical manufacturing professionals
  • CRO management and staff
Instructor Profile:
Daniel Norwood

Daniel Norwood
Executive Partner, SCIO Analytical Consulting LLC

Dr. Daniel Norwood joined SCIO Analytical as Executive Partner in June 2015. Prior to SCIO Analytical, Dr. Norwood was a key technical employee at Boehringer Ingelheim Pharmaceuticals where he was successful in various pharmaceutical development roles, including Director Physical and Chemical Analysis. In June 2015, Dr. Norwood retired with the title of Distinguished Research Fellow in Analytical Development. Prior to joining Boehringer Ingelheim, Dr. Norwood, with Dr. Feinberg, founded the Structural Chemistry Group at Magellan Laboratories, later Catalent Pharma Solutions, which became widely recognized for its work in pharmaceutical impurity structure elucidation, and in leachables and extractables characterization. Prior to Magellan, he was a pharmaceutical development scientist at the Glaxo Research Institute.

Dr. Norwood is an internationally recognized expert in the field of leachables and extractables assessment in pharmaceutical development and manufacturing. He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on extractables and leachables. Dr. Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013). Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his doctorate degree in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.

Follow us :
Project Management in Human Resources - 80334SEM
Computer System Validation - Reduce Costs and Avoid 483s

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).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading