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2010
Pharmaceutical & Biotech Course
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A Practical Introduction
to Design of Experiments
- A
Practical Introduction to Regression Analysis
- ADME,
PK/TK, and Drug Metabolism in Drug Discovery and Development
- Adverse
Drug Events – Understanding and Reporting Requirements
- Agitator
Design Principles for Bioprocessing and Pharmaceutical
Applications
- Analytical
Method Validation for Pharmaceutical, Biopharmaceutical,
and Biologics Quality Control
- Aseptic
Processing in the Manufacture of Biotech and Pharmaceutical
Products
- BioManufacturing
of Protein Therapeutics: Rewards and Challenges
- Biostatistics
for Non-Statisticians
- cGMP
for Quality Assurance and Quality Control of Pharmaceuticals,
Biopharmaceuticals, and Biologics
- Chiral
Pharmaceuticals: Analysis and Separation
- Cleanroom
Microbiology for the Non-Microbiologist
- CMC
Regulatory Compliance for Biopharmaceuticals and Biologics
- Comprehensive
Overview of FDA Regulatory Compliance for Drugs and
Biotech Products
- Core
Skills for Team Development
- Current
Good Laboratory Practices & Current Good Manufacturing
Practices - A Basic Primer
- Cutting-Edge
Analytical Techniques for Biotechnology Products
- Dermatological
Product Development
- Design
Control for Medical Device Professionals
- Effective
Document Management for the Pharmaceutical, Biotech
& Medical Device Industries
- Effective
Quality Assurance Auditing for FDA Regulated Industries
- Effective
Risk-Based Applications of cGMPs for Cosmetics and OTC
Drug Products
- European
Filing & Registration Procedures
- FDA
Inspections of Clinical Data Systems
- FDA
Inspections: What To Expect And How To Prepare
- Financial
Fundamentals for Non-Financial Personnel - How Financial
Issues Impact Business
- Generic
Drug Approvals: Preparing an ANDA for First-Cycle Approval
- Good
Clinical Practices (GCPs)
- Good
Laboratory Practices for Pre-Clinical Testing: Compliance,
QA and Audit
HIPAA And Its Effect On Clinical Trials/Human Subject
Research
- How
to Implement Risk Management Principles and Activities
Within a Quality Management System
- How
to Monitor Clinical Trials for GCP Compliance
- How
to Prepare for a Systems-based Inspection – Understanding
the FDA’s Risk-based Inspections Approach and
Ensuring Compliance
- Introduction
to Effective Medical Writing
- Introduction
to Molecular Biology Techniques – Applications
in the Biotechnology and Pharmaceutical Industries
- Introduction
to Statistical Analysis of Laboratory Data
Laboratory Safety - Basics and Beyond
- Management,
Supervisory & Leadership Skills for R&D Personnel
- Moving
from Discovery Into Development
- Outsourcing
for the Therapeutic Products Industry
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Outsourcing Preclinical Toxicology Studies
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Overview Of FDA Regulatory Compliance For Medical Devices
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Pharmaceutical Counterfeits and Intellectual Property
Rights Infringement in China
- Pharmaceutical
Water Systems: Contemporary Technology and Compliance
- Pharmaceutical,
Biopharmaceutical, and Biologics Quality Control Laboratories:
A Regulatory Compliance Primer
- Practical
Methods for Project Management
- Preparation
of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval
Supplements) and Communicating with the FDA
- Preparing
the CMC Section for NDA’s/IND’s/CTD’s
- Process
Validation for Drugs and Biologics
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Project Management for Phase 1 & 2 Clinical Trials
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Project Management for the Phase 3 and LCM (Life Cycle
Management) of the Drug Development Process
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Protein Chromatography - From Analytical Methods Development
to Downstream Purification
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QA/QC Strategy for Biologics and Biopharmaceuticals
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Quality System Regulation for the Medical Device &
Biotech Industries
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Reporting Failure Investigations and Process Deviations
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Root Cause Analysis for CAPA
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Safety Pharmacology in Drug Development
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Selecting and Managing CRO’s
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Stability Programs from Development to Approval - An
Overview
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Stability Testing of Proteins, Peptides & Other
Biomolecules
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Sterilization Procedures: Technology, Equipment and
Validation
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Technical Writing for the Pharmaceutical, Medical Device,
and Biotech Industries
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The CTD: Practical Implementation of the ICH Common
Technical Document Format for Market Application Submissions
(NDAs, ANDAs, BLAs, MAAs)
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The Drug Development Process - From Discovery to Commercialization
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The EU Clinical Trial Directive
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Validation of Computer Systems
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Writing Effective Standard Operating Procedures and
Other Process Documents
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Writing in the Regulated Environment When English Is
Your Second Language
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