Analytical Methods Validation for FDA Compliance Sep 13 2010, Burlingame, CA |
CMC Submissions in CTD Format Sep 20 2010, Burlingame, CA |
Skin Product Development Sep 20 2010, New Brunswick, NJ |
Documentation Management and Control Sep 27 2010, East Brunswick, NJ |
Preparation, Packaging and Labeling of Clinical Trial Materials Sep 27 2010, East Brunswick, NJ |
Preparing for and Surviving an FDA Inspection Sep 29 2010, East Brunswick, NJ |
Generic Drug Approvals Oct 04 2010, New Brunswick, NJ |
Skin Product Development Oct 11 2010, Amsterdam, The Netherlands |
Lyophilization Technology Oct 12 2010, New Brunswick, NJ |
Design Control and Product Validation Oct 18 2010, New Brunswick, NJ |
Powders: Their Properties and Processing Oct 18 2010, Amsterdam, The Netherlands |
Preparation, Packaging and Labeling of Clinical Trial Materials Oct 18 2010, Amsterdam, The Netherlands |
Developing and Maintaining an Effective Complaint System Oct 20 2010, New Brunswick, NJ |
Developing and Maintaining an Effective Complaint System Oct 20 2010, New Brunswick, NJ |
Developing and Maintaining an Effective Complaint System Oct 20 2010, New Brunswick, NJ |
Analytical Methods Validation for FDA Compliance Oct 25 2010, Amsterdam, The Netherlands |
Conducting Effective Quality Audits Oct 25 2010, New Brunswick, NJ |
Pharmaceutical Supervisory Management Skills Oct 27 2010, New Brunswick, NJ |
CMC Submissions in CTD Format Nov 04 2010, Amsterdam, The Netherlands |
Microbiological Control and Validation Nov 08 2010, Amsterdam, The Netherlands |
Critical Process Cleaning and Cleaning Validation Dec 01 2010, Amsterdam, The Netherlands |
Transdermal Drug Delivery Dec 02 2010, New Brunswick, NJ |
Drug Product Stability and Shelf-Life Dec 13 2010, Amsterdam, The Netherlands |
ICH-Q7 Dec 13 2010, Amsterdam, The Netherlands |
ICH-Q7 Dec 13 2010, Amsterdam, The Netherlands |
Active Pharmaceutical Ingredients 840 |
Active Pharmaceutical Ingredients 840 |
ADME Fundamentals 2077 |
Advanced Tablet Press Operation 2206 |
Annual Product Reviews (APRs) For Pharmaceuticals 1998 |
Annual Product Reviews (APRs) For Pharmaceuticals 1998 |
Applied cGMPs for Pharmaceutical and Allied Industries 610 |
Assuring Quality of Supplies to Pharmaceutical and Related Industries 2387 |
Auditing and Inspecting Preclinical Research for GLP Compliance 1774 |
Auditing for cGMP Compliance 1881 |
Biopharmaceutical Process Systems 1116 |
Biosafety of Biological Drug Products 2228 |
Biostatistics for the Non-Statistician - Beyond the Basics 2101 |
Bringing Nanotechnology to Your Market 2157 |
Calibration in the FDA Regulated Industry 2026 |
cGMP Auditing - Strategies for Compliance 2012 |
cGMP for Pharmaceutical Production Supervisors 604 |
cGTP in a Nutshell 2179 |
cGTP in a Nutshell 2179 |
Clean Room Technology 23 |
Combination Product Development: Safety/Registration/Approval 2104 |
Commissioning, Qualification and Validation 1954 |
Complaint Systems - The Essential Requirements 2132 |
Complaint Systems - The Essential Requirements 2132 |
Computerized Systems Used in Clinical Investigations: the New FDA Guidance 2184 |
Conducting Compliant Endotoxin Testing 2185 |
Cost Effective Quality-by-Design and Critical-to-Quality Tools for PAT 2127 |
Cost Effective Quality-by-Design and Critical-to-Quality Tools for PAT 2127 |
Current Good Manufacturing Practice (cGMP) for Purchasing 1836 |
Current Good Tissue Practices (cGTPs) 2086 |
Developing Specifications for Drug Substances (APIs) and Drug Products 1918 |
Developing Specifications for Drug Substances (APIs) and Drug Products 1918 |
Developing Specifications for Drug Substances (APIs) and Drug Products 1918 |
Early Stage Clinical Studies for Drugs and Devices 2118 |
Suspensions and Emulsions in Pharmaceuticals and Food 274 |
Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals 526 |
Endotoxin Testing: Resolving Interference and Test Validation 2204 |
Excipient GMPs 2050 |
FDA Drug Development and Compliance 587 |
Fundamentals of Biochemistry: Background for Biotechnology 33 |
Fundamentals of Biotechnology 2197 |
Fundamentals of Molecular Biology and Genetic Engineering 1377 |
Fundamentals of Nanotechnology 2111 |
Getting a Share of the BioDefense Grant Billions 2205 |
GMP for Dietary Supplements 2094 |
Good Clinical Practices (GCP) 107 |
Good Distribution Practices 2116 |
Good Laboratory Practices (GLP) 545 |
Granulation, Tabletting and Capsule Technology 541 |
Guidelines for Skin Absorption Studies 2220 |
Guidelines to In Vitro Skin Absorption Studies 2202 |
ICH Q10: Pharmaceutical Quality System 2131 |
Pharmaceutical Risk Management Tools: Getting the Most Out of ICH Q9 2158 |
Safety Assessment of Cosmetic Ingredients and Formulations 2161 |
Safety Assessment of Cosmetic Ingredients and Formulations 2161 |
INDs/NDAs/CTDs 448 |
INDs/NDAs/CTDs 448 |
Introduction to Drug Delivery Technology 2084 |
Introduction To Pharmaceutical cGMP 2244 |
IQ, OQ, PQ 1808 |
ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies 2092 |
Laboratory Control System 2047 |
Laboratory Control System 2047 |
Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals 526 |
Medical Device Regulatory Compliance 1992 |
Near Infrared Spectroscopy 1583 |
Near Infrared Spectroscopy 1583 |
Non-Clinical Drug Safety Evaluation and Drug Development 1153 |
Nutritional Supplement Formulation Basics 2246 |
Orphan Drug Application and Submission 2223 |
Packaging of Pharmaceuticals 42 |
PAT-Based Downstream Protein Purification 2130 |
Pathways to Skin Penetration 2149 |
Pharma: Concept To Consumer 2115 |
Applied cGMPs for Pharmaceutical and Allied Industries 610 |
Pharmaceutical Process Development 1358 |
Pharmaceutical Quality Assurance and Control 224 |
Pharmaceutical Risk Management Tools: Getting the Most Out of ICH Q9 2158 |
Pharmaceutical Technology Transfer 2095 |
Near Infrared Spectroscopy 1583 |
Pharmaceutical Water: Chemistry, System Design and Validation 2211 |
Practical Biostatistics for the Non-Statistician - The Basics 468 |
Real World Approaches to PAT and QbD Implementation 2085 |
Real World Approaches to PAT and QbD Implementation 2085 |
Real World Approaches to PAT and QbD Implementation 2085 |
Process Validation for Packaging of Pharmaceuticals and Medical Devices 1789 |
Process Validation for the Pharmaceutical and Medical Device Industries 736 |
Process Validation for the Pharmaceutical and Medical Device Industries 736 |
Qualification and Validation of Analytical Methods for Protein Products 1933 |
Real World Approaches to PAT and QbD Implementation 2085 |
Recognizing and Preventing Data Integrity Issues 2349 |
Regulatory Compliance for the Personal Care Products Industry 1522 |
Risk Management Today: Complying with the ISO 14971: 2007 Standard 2106 |
Risk Management Today: Complying with the ISO 14971: 2007 Standard 2106 |
Risk Management Today: Complying with the ISO 14971: 2007 Standard 2106 |
Role of PAT and QbD in Biologic Drug Production 2163 |
Role of Pharmaceutical QA/QC in Quality Systems 2294 |
Safety Assessment of Cosmetic Ingredients and Formulations 2161 |
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes) 1948 |
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes) 1948 |
Commissioning, Qualification and Validation 1954 |
Selecting and Managing CROs 2032 |
Skin Inflammation – Reasons, Prevention, Treatment and Testing 2217 |
Starch: Chemistry, Properties and Applications 542 |
Sterile Products: Formulation, Manufacture and Quality Assurance 435 |
Sterile Products: Formulation, Manufacture and Quality Assurance 435 |
Sterilization in the Pharmaceutical Industry 2075 |
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites 1880 |
Suspensions and Emulsions in Pharmaceuticals and Food 274 |
System Validation, GAMP Harmonization and P.A.T 913 |
System Validation, GAMP Harmonization and P.A.T 2203 |
Tablet Production for Operators and Supervisors 1428 |
GLP Study Director 2136 |
Quality System 2046 |
FDA Drug Development and Compliance 587 |
FDA Drug Development and Compliance 587 |
Vendor and Contract Supplier Qualification 1984 |
Bringing Nanotechnology to Your Market 2157 |
Writing and Implementing Clinical Protocols 772 |
Writing SOPs for cGMP Compliance 1646 |