Goals & Objectives

Developing a drug product and bringing it to market requires an in-depth understanding of the science, technology, regulations and risk management strategies behind developing safe and effective drug products. This is a comprehensive introduction to the FDA Regulations that govern the drug development process for both innovative, generic, and OTC drug products. The program will cover: 1) FDA’s drug registration requirements from discovery through the post-approval process; 2) GMP compliance requirements for R&D drug development, technology transfer, and the routine manufacture of pharmaceutical products; 3) Laboratory GLPs and GLPs for non-clinical studies; 4) the GCP regulations; and, 5) FDA’s inspectional posture with the Bioresearch Monitoring Program, Pre-Approval Inspections and general field GMP inspections.

This course is intended for pharmaceutical scientists and technical and administrative personnel, both new and experienced, from R&D, QC, QA, Manufacturing, Project Management, Regulatory Affairs, CROs, Contract Pharma, and Sales and Marketing, who are involved in the development, approval and manufacturing of pharmaceutical products. Participants will find this program to be an excellent up-to-date resource for understanding the continually changing regulatory environment related to the development and manufacture of pharmaceutical products; and, for becoming more effective, productive, and cost-effective team members in executing their job responsibilities and tasks as related to the regulatory climate.

This course is intended for pharmaceutical scientists and technical and administrative personnel, both new and experienced, from R&D, QC, QA, Manufacturing, Project Management, Regulatory Affairs, CROs, Contract Pharma, and Sales and Marketing, who are involved in the development, approval and manufacturing of pharmaceutical products. The regulatory environment for drug development is constantly changing. Participants will find this program to be an excellent up-to-date resource for understanding the regulations related to the development and manufacture of pharmaceutical products and for becoming more effective, productive, and cost-effective team members in executing their job responsibilities and tasks as related to the regulatory climate.

Last years course evaluation results.

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Contents

Contents:

1. FDA Laws, Regulations and Current Initiatives for Drug Development.
2. FDA/ICH Guidelines – Overview.
3. The Drug Development Timelines and Process; Planning for Success; and, Filing INDs.
4. Clinical Testing Phases, Informed Consent and IRBs.
5. Differences Between/Information Required for Filing INDs, NDAs, ANDAs, OTCs; Filing Pitfalls.
6. Electronic Filings, Meetings with FDA, Drug Master Files and the Summary Basis of Approval.
7. ANDAs; 505(j) and 505(b)(2) applications; and, the QbR approach to generic submissions.
8. The Preclinical Sections of INDs including the CMC Requirements.
9. Analytical/Product Development Aspects of the IND/NDA/ANDA Process, Quality Assessments, Quality-by-Design, Design Space, Critical Quality Attributes and the setting of Specifications.
10. Analytical Method Development, Process Validation, Technology Transfer and Stability Studies.
11. Post Approval Responsibilities including ADEs, Field Alerts, Annual Reports and Supplements.
12. GLPs for Non-Clinical Studies 21 CFR 58; and, the GMPs vs. GLPs: what, when and where?
13. The GMP Regulations 21 CFR 210-211: Intent, Spirit, Scope, and the Quality Systems Approach.
14. FDA’s GMP Position/Requirements for Active (bulk) Pharmaceutical Ingredients.
15. Training for predicate rule compliance; and, Management of Record Keeping and SOPs per GXPs.
16. PAIs, the BIMO Program; and FDA’s GMP Enforcement Findings and Actions.

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