Pharmaceutical Training Courses
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| Title | Provider | Media | Primary Office | Language |
|---|---|---|---|---|
| ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Adverse Drug Events - Understanding and Reporting Requirements | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Agitator Design Principles for Bioprocessing and Pharmaceutical Applications | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Biomanufacturing of Protein Therapeutics: Rewards and Challenges | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Biostatistics for Non-Statisticians | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| This course is designed as an introduction to the statistical principles that form the basis for design & analysis of research investigations and will focus on the concepts and statistical methods required in biological and health science research. | ||||
| cGMP for Quality Assurance and Quality Control of Pharmaceuticals, Biopharmaceuticals, and Biologics | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Cleanroom Microbiology for the Non-Microbiologist | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| CMC Regulatory Compliance for Biopharmaceuticals and Biologics | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Current Good Laboratory Practices & Current Good Manufacturing Practices - A Basic Primer | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Dermatological Product Development | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Developability Assessment - The Logical Approach to Discovery Lead Selection | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Effective Document Management for the Pharmaceutical, Biotech and Medical Device Industries | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Effective Quality Assurance Auditing for FDA Regulated Industries | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| This seminar is designed for quality managers, auditors, production managers and top management interested in learning the value of a "good audit" to the company, how to prepare for a "good audit", & how to enhance auditing as a valuable QA tool. | ||||
| European Filing & Registration Procedures | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| This course specifically focuses on agencies that control the regulatory process. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of European regulatory agencies. | ||||
| FDA Inspections - What To Expect & How To Prepare | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Attendees are taken step-by-step through the inspection process and review various types of inspections, including pre-approval inspections, routine GMP inspections, bioresearch monitoring inspections, quality systems inspection techniques. | ||||
| FDA Inspections of Clinical Data Systems | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Financial Fundamentals for Non-Financial Personnel - Understanding How Financial Issues Impact Business | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Generic Drug Approvals - Preparing an ANDA for First-Cycle Approval | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Good Clinical Practices (GCPs) | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| This course is specifically designed for Clinical Research Monitors (CRMs) and Clinical Research Auditors (CRAs) who need basic and expanded knowledge in FDA and ICH Regulations for Good Clinical Practices (GCPs). | ||||
| Good Laboratory Practices for Pre-Clinical Testing: Compliance, QA and Audit | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| How to Monitor Clinical Trials for GCP Compliance | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| How to Prepare for a Systems-based Inspection - Understanding the FDA's Risk-based Inspection Approach and Ensuring Compliance | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Introduction to Effective Medical Writing | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Laboratory Safety - Basics and Beyond | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Pharmaceutical Water Systems: Contemporary Technology and Compliance | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Pharmaceutical, Biopharmaceutical, and Biologics Quality Control Laboratories: A Regulatory Compliance Primer | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Practical Methods for Project Management | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| This workshop will be of value to those in the pharmaceutical, biotech and medical devices industries who are responsible for directing projects and will provide a strong understanding of the principles and practices of Project Management. | ||||
| Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| This course discussed the strategies and options available when submitting INDs, NDAs, BLAs, 510Ks, ANDAs, and SNDAs. The submission process will be discussed as it relates to FDA rules, regulations and requirements. | ||||
| Preparing the CMC Section for NDAs/INDs/CTDs | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Process Validation for Drugs and Biologics | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Project Management for Phase 1 & 2 Clinical Trials | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Project Management for the Phase 3 and LCM (Life Cycle Management) | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Protein Chromatography - From Analytical Methods Development to Downstream Purification | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| QA/QC Strategy for Biopharmaceuticals and Biologics | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Reporting Failure Investigations and Process Deviations | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Root Cause Analysis for CAPA | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| The primary objective of this course is to develop an understanding of the principals and techniques involved in the practice of Root Cause Analysis. Emphasis is placed on the practical aspects of how to perform an analysis. | ||||
| Skin Product Development | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Stability Programs from Development to Approval | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Stability Testing of Proteins, Peptides & Other Biomolecules | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| This course provides comprehensive and up-to-date knowledge of stability testing for quality assurance and control of protein and peptide biopharmaceuticals and biologics. | ||||
| Sterilization Procedures: Technology, Equipment and Validation | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| This course will analyze the contents and organization of the ICH Common Technical Document and compare these with those previously specified by the Code of Federal Regulations for INDs, NDAs, ANDAs and BLAs. | ||||
| Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Techniques on Effective Writing & Reviewing of Clinical Study Documents | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| The CTD: Practical Implementation of the ICH Common Technical Document Format for Market Application Submissions (NDAs, ANDAs, BLAs, MAAs) | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| This course will analyze the contents and organization of the ICH Common Technical Document and compare these with those previously specified by the Code of Federal Regulations for INDs, NDAs, ANDAs and BLAs. | ||||
| The Drug Development Process - From Discovery to Commercialization | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| This course covers current FDA regulatory compliance with respect to developing, registering, manufacturing, and marketing medical devices, including the FD&C Act, case law, and the FDA?s authority to promulgate and enforce regulations. | ||||
| The EU Clinical Trial Directive | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| This course focuses on the EU Clinical Trial Directive and issues inherent in a new regulatory process. Included are relevant topics associated with the Directive, the reasons behind its introduction & review of a methods for effective implementation. | ||||
| Validation of Computer Systems | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Writing Effective Standard Operating Procedures and Other Process Documents | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |
| Writing in the Regulated Environment when English in your Second Language | The Center for Professional Innovation & Education | Public & Onsite Schedule,Experiential,Activity Based Training |
USA | English |