ComplianceOnline

Clearing up Roles and Responsibilities in the GLPs

Instructor: Anne E Maczulak
Product ID: 701092
  • Duration: 60 Min

recorded version

$299.00
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: Jan-2009

Training CD

$500.00
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 GLP (Good Laboratory Practices) webinar presents a straightforward summarization of the roles and responsibilities of all the people that contribute to a GLP study.

It emphasizes the three required elements: study director, management, and QAU (Quality Assurance Unit). It also reviews the main mistakes that FDA sees continually in inspections. The webinar also lists the roles and responsibilities of participating scientists, archivists, and sponsors. It clarifies the signature/approval process. Finally, this webinar covers difficult situations between sponsor-management and sponsor-study director..

Areas Covered in the seminar:

  • Key personnel in a GLP(Good Laboratory Practices)study.
  • The main roles of key personnel.
  • Management.
  • Study director and principal investigators.
  • Study personnel, participating scientists, and archivist.
  • Sponsors.
  • Clearing up confusion in roles and responsibilities.

Who Will Benefit:

This Good Laboratory Practices training targets people who have experience in GLP studies. It intends to correct some of the common mistakes even experienced personnel have when it’s time to plan, conduct, and report on studies. It puts emphasis on managing situations in which people overstep their roles or do not meet their responsibilities. This content is best suited to:

  • Management
  • Study directors
  • Principal investigators
  • Study scientists
  • QA representatives
  • Sponsor

Instructor Profile:

Anne E. Maczulak, is Principal Consultant of Acorn GLP Consulting, based in the San Francisco Bay Area. She provides FDA and EPA Good Laboratory Practice compliance audits, training, and guidance to large and small companies in pharmaceuticals, devices, biotechnology, and chemicals. She has also provided GLP guidance for university-based studies. Acorn GLP Consulting specializes in helping companies and university laboratories new to preclinical studies build strong quality assurance and GLP programs from the ground up.

Anne worked in industry for 20 years at pharmaceutical and consumer products companies. During that time she served as a GLP sponsor, study director, and participating scientist.

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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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