Webinar On "GMPs for Active Pharmaceutical Ingredients"

Event Details

Time: February 21, 2018 from 1pm to 2:30pm
Location: Online
Street: 9106 Seven Locks Road
City/Town: Bethesda
Website or Map: http://bit.ly/2BTysHQ
Phone: 1-844-216-5230
Event Type: online, /, webinar
Organized By: Sam Miller
Latest Activity: Feb 12, 2018

Export to Outlook or iCal (.ics)

0 members like this

Event Description

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
1. Senior management
2. Site managers
3. Materials
4. Production
5. Quality Control
6. Quality Assurance
  1. Reviewer
  2. Auditor
In the Drug Product Manufacturer
1. Purchasing agents
2. Quality Assurance
3. Quality Control
4. 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.