PALO ALTO, Calif. (PRWEB) January 25, 2018
Watch the live recorded streaming video of seminar over the Internet. The seminar broadcast includes speaker videos and coordinated PowerPoint presentations.
This training will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.
- Learn about the regulatory background and GMP requirements for quality control and contract laboratories.
- Understand and be able to explain your company’s quality plan or laboratory compliance master plan.
- Understand the difference between GMP and non-GMP laboratories.
- Learn how to develop inspection ready documentation.
- Be able to train others in your organization on GMP requirements.
- Learn how to avoid and/or respond to the FDA inspectional observations and warning letters.
Handouts/ Bonus Material for Easy Implementation (available as web downloads):
- 50-Page primer: FDA GMP Compliance in Analytical Laboratories
- Laboratory Compliance Master Plan
- Worksheet – Laboratory Audits
- Standard Operating Procedures (27 SOPs)
Dr. Ludwig Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences. He served as a team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on laboratory equipment. In addition, he was awarded as Presenter of the Year of the Institute for Validation and Technology. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press.
Registration: Contact customercare(at)complianceonline(dot)com or call +1-888-717-2436 to get registration details of this seminar.
ComplianceOnline is a leading provider of regulatory compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 55,000 professionals from 15,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (http://www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions for global corporations.
For more information please contact:
A Reuben Bernard
Associate Director - ComplianceOnline
2600 E Bayshore Rd
Palo Alto CA USA 94303
Phone - +1-650-238-9656 | +1-888-717-2436
Fax - 650-362-2367