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CfPIE's Training Courses:
Website:
Pharmaceutical, Biotech and Medical Device Training from CfPIE
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Courses offered in the United States:
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March 2010
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Mar. 17 – 19
 Technical
Writing for Pharmaceutical, Medical Device and Biotech Industries
Malvern, PA
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Mar. 22 & 23
Project
Management for Phase 1 & 2 Clinical Trials Malvern, PA
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Mar. 22 & 23
Aseptic
Processing in the Manufacture of Biotech and Pharmaceutical Products
Costa Mesa, CA
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Mar. 22 & 23
Pharmaceutical
Production Batch Record Review Costa Mesa, CA
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Mar. 24 – 26
Optimization
of Drug-Like Properties in Drug Discovery – Assessment and Structure
Modification Strategies Costa Mesa, CA
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Mar. 24 & 25
Project
Management for the Phase 3 and LCM (Life Cycle Management) of the Drug
Development Process Malvern, PA
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Mar. 29 & 30
Selecting
and Managing CRO's Malvern, PA
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Mar. 31-Apr. 1
Drug
Master Files (DMFs) - Understanding and Meeting Your Regulatory and
Processing Responsibilities Malvern, PA
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| April 2010
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Apr. 7 – 9
Active Pharmaceutical Ingredient (API) and Drug Product Specifications
King of Prussia, PA
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Apr. 8 & 9
Quality System Regulation for the Medical Device & Biotech Industries
King of Prussia, PA
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Apr. 12 & 13
How to Monitor Clinical Trials for GCP Compliance King of
Prussia, PA
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Apr. 12 & 13
Best Practices for Facilities and Utilities Design, Qualification and
Monitoring – Applying the Life-Cycle Concept King of Prussia, PA
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Apr. 14 & 15
Effective Qualification and Monitoring of Processing Equipment and their
Control Systems King of Prussia, PA
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Apr. 15 & 16
Patent and Other Intellectual Property Law for the Life Sciences Industry
Costa Mesa, CA
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Apr. 19 & 20
Effective Quality Assurance Auditing for FDA Regulated Industries
Costa Mesa, CA
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Apr. 19 – 21
Biostatistics for Non - Statisticians King of Prussia, PA
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Apr. 20 & 21
Pediatric Clinical Trial Design - Ethics, Management and Regulatory
Requirements King of Prussia, PA
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Apr. 21 - 23
Process Validation for Medical Devices Costa Mesa, CA
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Apr. 21 - 23
The Drug Development Process - From Discovery to Commercialization Costa Mesa, CA
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Apr. 22 & 23
Introduction to Statistical Analysis of Laboratory Data King of
Prussia, PA
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Apr. 26 & 27
Validation of Computer Systems Costa Mesa, CA
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Apr. 26 & 27
How to Implement Risk Management Principles and Activities within a
Quality Management System Costa Mesa, CA
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Apr. 28 & 29
Dermatological Product Development Malvern, PA
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Apr. 28 & 29
Essentials of Program, Project & Portfolio Management in
Bio/Pharmaceutical Discovery Malvern, PA
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| May 2010
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May 3 – 5
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics
and Medical Devices Costa Mesa, CA
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May 4 & 5
Latin America - Understanding Regulatory Compliance Requirements
Malvern, PA
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May 4 & 5
Software Development for Medical Device Professionals Malvern,
PA
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May 6 & 7
Effective Laboratory Safety Management Malvern, PA
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May 6 & 7
Japan - Regulatory Filing Requirements and Compliance Processes for Life
Sciences Malvern, PA
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May 6 & 7
Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A
Regulatory Compliance Primer Costa Mesa, CA
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May 10 & 11
Good Laboratory Practices (GLP) for Pre-Clinical Testing Costa
Mesa, CA
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May 10 & 11
Marketing, Advertising and Promotion of Pharmaceuticals and Medical
Devices Costa Mesa, CA
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May 11 & 12
Best Practices for an Effective Cleaning Validation Program
Costa Mesa, CA
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May 12 – 14
Good Manufacturing Practices Costa Mesa, CA
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May 13 & 14
Detecting Fraud and Misconduct in Clinical Trials Costa Mesa, CA
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May 13 & 14
Process Validation for Drugs and Biologics Costa Mesa, CA
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May 17 & 18
Writing Effective Standard Operating Procedures and Other Process
Documents Costa Mesa, CA
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May 17 & 18
Pharmaceutical Water Systems: Contemporary Technology & Compliance
Costa Mesa, CA
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May 18 & 19
Good Monitoring Practices for Medical Devices Malvern, PA
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May 19 & 20
Auditing and Qualifying Suppliers and Vendors Costa Mesa, CA
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May 20 & 21
Medical Devices - EU Directives, Guidance, CE Marking and ISO Standard
Certifications Malvern, PA
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May 20 & 21
Writing in the Regulated Environment When English Is Your Second Language
Costa Mesa, CA
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May 24 - 26
ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
Costa Mesa, CA
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May 24 – 26
Tablets & Capsules - Development, Manufacture and Testing of Solid Oral
Dosage Forms Malvern, PA
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| June 2010
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June 2 – 4
CMC Regulatory Compliance for Biopharmaceuticals and Biologics
Costa Mesa, CA
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June 3 & 4
Practical Methods for Project Management King of Prussia, PA
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June 7 – 9
Good Clinical Practices (GCP) Costa Mesa, CA
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June 7 – 9
QA/QC Strategy for Biopharmaceuticals and Biologics Costa Mesa,
CA
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June 9 – 11
Reporting Failure Investigations and Process Deviations King of
Prussia, PA
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June 10 & 11
Adverse Drug Events – Reporting & Regulatory Requirements Costa
Mesa, CA
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June 10 & 11
Detecting Fraud and Misconduct in Clinical Trials King of
Prussia, PA
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June 10 & 11
Analytical Method Validation for Biologics, Biopharmaceuticals and Other
Therapeutic Products Costa Mesa, CA
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June 14 & 15
FDA Inspections of Clinical Data Systems Costa Mesa, CA
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June 14 – 16
The CTD/eCTD: Building the Marketing Application throughout Clinical
Development Costa Mesa, CA
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June 14 & 15
Preparing the CMC Section for NDAs/CTDs/INDs King of Prussia, PA
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June 14 & 15
Overview of FDA Regulatory Compliance for Medical Devices King
of Prussia, PA
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June 16 & 17
How to Prepare for a Systems-based Inspection - Understanding FDA's
Risk-based Inspections Approach King of Prussia, PA
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June 17 & 18
Effective Risk-Based Applications of Drug cGMPs and Validation
Requirements for Cosmetics and OTC Drug Products King of
Prussia, PA
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June 22 & 23
Project Management for Phase 1 & 2 Clinical Trials Costa Mesa,
CA
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June 22 & 23
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval
Supplements) and Communicating with the FDA Costa Mesa, CA
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June 23 – 25
The Drug Development Process - From Discovery to Commercialization
King of Prussia, PA
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June 24 & 25
Project Management for the Phase 3 and LCM (Life Cycle Management) of the
Drug Development Process Costa Mesa, CA
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June 24 & 25
Stability Programs for Product Shelf Life - From Development to Approval
Costa Mesa, CA
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June 28 & 29
Quality System Regulation for the Medical Device & Biotech Industries
Costa Mesa, CA
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Courses offered in Europe:
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March 2010
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Mar. 22 & 23
Overview
of FDA Regulatory Compliance for Medical Devices Dublin,
Ireland
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Mar. 24 – 26
Root
Cause Analysis for CAPA Dublin, Ireland
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Mar. 29 & 30
Effective
Quality Assurance Auditing for FDA Regulated Industries
Dublin, Ireland
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| April 2010
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Apr. 8 & 9
Project Management for Phase 1 & 2 Clinical Trials Dublin,
Ireland
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Apr. 12 & 13
Project Management for the Phase 3 and LCM (Life Cycle Management) of the
Drug Development Process Dublin, Ireland
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Apr. 12 & 13
Analytical Method Validation for Biologics, Biopharmaceuticals and Other
Therapeutic Products Berlin, Germany
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Apr. 12 – 14
Technical Writing for Pharmaceutical, Medical Device and Biotech
Industries Berlin, Germany
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Apr. 14 – 16
CMC Regulatory Compliance for Biopharmaceuticals and Biologics
Berlin, Germany
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Apr. 15 & 16
Writing Effective Standard Operating Procedures and Other Process
Documents Berlin, Germany
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Apr. 19 – 21
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics
and Medical Devices Dublin, Ireland
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Apr. 19 – 21
QA/QC Strategy for Biopharmaceuticals and Biologics Berlin,
Germany
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Apr. 19 & 20
Effective Document Management for the Pharmaceutical, Biotech & Medical
Device Industries Berlin, Germany
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Apr. 22 & 23
Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A
Regulatory Compliance Primer Dublin, Ireland
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Apr. 22 & 23
Medical Devices - EU Directives, Guidance, CE Marking and ISO Standard
Certifications Berlin, Germany
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Apr. 22 & 23
Introduction to Effective Medical Writing Berlin, Germany
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Apr. 26 & 27
The EU Clinical Trial Directive Berlin, Germany
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Apr. 26 & 27
FDA Inspections of Clinical Data Systems Dublin, Ireland
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Apr. 28 & 29
European Filing & Registration Procedures Berlin, Germany
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| May 2010
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May 17 & 18
Practical Methods for Project Management Berlin, Germany
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May 19 – 21
Root Cause Analysis for CAPA Berlin, Germany
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May 24 & 25
Clinical Trial Design for Medical Devices Berlin, Germany
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May 24 & 25
Overview of FDA Regulatory Compliance for Medical Devices
Berlin, Germany
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