Recent Updates and Highlights of FDA and other cGMP Regulations
Formerly known as “Highlights of FDA and other cGMP Regulations”. This 1 Day presentation aims at covering the basic tenets of the cGMP Regulations (FDA, EMEA, etc) as applicable to the Pharmaceutical, Biotech and related healthcare industries ,while outlining the major responsibilities and duties of key Management and other personnel working in different functions of the companies.
This 1 Day presentation aims at covering the basic tenets of the cGMP Regulations (FDA, EMEA, etc) as applicable to the Pharmaceutical, Biotech and related healthcare industries ,while outlining the major responsibilities and duties of key Management and other personnel working in different functions of the companies. This short course will describe the sources and bringing out interpretations of various regulations as published by the Regulatory Agencies (FDA,EMEA, etc.) and their implications in various aspects of compliance to such regulations. The most current directives of ICH including Risk Based Strategy and a science based Policy will be outlined .
The roles of International organizations such as ICH (International Conference on Harmonization), WHO (World Health Organization) and other guidance documents will also be touched upon. The course will also help attendees in understanding the preparation for Regulatory inspections and how to avoid FDA Enforcement Actions.
The style of this presentation is highly interactive and collaborative. Audience participation is encouraged and emphasized to derive the most benefit
Who Should Attend
- Management, R&D Personnel, Quality Assurance (QA), Quality Control (Q,C.)
- Processing Engineers, Manufacturing, Procurement
- Regulatory Affairs, Investigators, Auditors
- Global Scenario, International Bodies and Organizations
- Brief History of FDA and the Genesis of Regulations
- The 21st Century GMP Regulations
- Quality, Quality Systems and Quality Continuum
- Sources of Regulations CFR, FDA Directives etc.
- The Roles and Responsibilities of QA and QC
- Structure and Attributes of a robust Quality System
- General layout and various Systems within a cGMP Facility
- Policies, Protocols, Flow Carts, SOP’s etc.
- Various Validation Activities and Their Implications
- Computer Systems: Risk Assessment (REMS), (ERES) and Part 11 Compliance
- Records, Storage, Retrieval and Archives
- Preparation for Audits and Inspections
- General Review
- Questions and Answers
- References, Web Addresses and Other Sources
About the Instructor
is a globally acclaimed speaker and consultant and has extensive experience in R&D, quality assurance, and quality management.