Description :
In this webinar we will discuss the regulatory expectations that apply to the production and control of active pharmaceutical ingredients. The discussion will start with the introduction of ICH Q7, the internationally accepted GMP for APIs, and discuss how this is supplemented by contemporary guidance such as ICH Q10, the Pharmaceutical Quality System, ICH Q8, Pharmaceutical Development, ICH Q9 Quality Risk Management and ICH Q11, Development and Manufacture of Drug Substances. The impact of new FDA guidance on Process Validation and Quality Metrics will also be considered.
Why you should attend :
The objective of this webinar is to provide a contemporary quality system approach to the production and control of active pharmaceutical ingredients. Although ICH 7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is only 15 years old, the pharmaceutical industry has gone through a significant transition to a quality system approach to development, compliance, production, and control. Compliance activities that include these contemporary concepts must be practiced in a compliant organization.
Areas Covered in the Session :
The following areas will be included:
Drug GMPs
ICH Q7
ICH Q8
ICH Q9
ICH Q10
ICH Q11
FDA Process Validation guidance
Data Integrity
Quality Metrics
Who Will Benefit:
In the API manufacturer
Senior management
Site managers
Materials
Production
Quality Control
Quality Assurance
Reviewer
Auditor
In the Drug Product Manufacturer
Purchasing agents
Quality Assurance
Quality Control
Quality auditor
About Speaker:
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.
In 1994 Dr. Lanese formed his own company, The Lanese Group, and since that time he has been a consultant in the area of quality system and cGMP compliance and has audited and consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.
Dr. Lanese focuses on training. He lectures throughout the world and presents training in all formats (lectures, seminars and webinars) on a variety of topics related to Quality Systems, GMPs, APIs, training, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. Jerry is a member of the Editorial Board of the Journal of GXP Compliance.
Event URL: http://bit.ly/2BTysHQ
