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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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May 2008
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May 19 & 20
Good Distribution Practices (GDP) & Directives: EU/WHO
Malvern, PA
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May 21 & 22
Roles and Responsibilities for GLP Study Directors, QAU &
Management (FDA/OECD) Malvern, PA
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May 29 & 30
Software Development for Medical Device Professionals
Costa Mesa, CA
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June 2008
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June 2 - 4
The CTD/eCTD: Building the Marketing Application Throughout
Clinical Development Costa Mesa, CA
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June 5 & 6
Drug Master Files (DMFs) - Understanding and Meeting Your
Regulatory and Processing Responsibilities Malvern,
PA
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June 5 & 6
Effective Risk-Based Applications of Drug cGMPs and Validation
Requirements for Cosmetics and OTC Drug Products
Malvern, PA
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June 9 & 10
Effective Quality Assurance Auditing for FDA Regulated
Industries Costa Mesa, CA
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June 10 & 11
Sterilization Procedures: Technology, Equipment and Validation
Malvern, PA
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June 11 & 12
How to Implement Risk Management Principles and Activities
Within a Quality Management System Costa Mesa, CA
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June 12 & 13
Cleanroom Microbiology for the Non-Microbiologist
Malvern, PA
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June 12 & 13
Good Laboratory Practices for Pre-Clinical Testing:
Compliance, QA and Audit Costa Mesa, CA
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June 16 & 17
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs,
Post-Approval Supplements) and Communicating with the FDA
Malvern, PA
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June 16 - 18
Good Clinical Practices (GCPs) Costa Mesa, CA
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June 18 - 20
QA/QC Strategy for Biologics and Biopharmaceuticals
Malvern, PA
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June 19 & 20
Adverse Drug Events – Reporting & Regulatory Requirements
Costa Mesa, CA
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June 19 & 20
Introduction to Effective Medical Writing Malvern,
PA
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June 23 & 24
Design Control for Medical Device Professionals
Malvern, PA
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June 23 & 24
Project Management for Phase 1 & 2 Clinical Trials
Costa Mesa, CA
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June 23 & 24
Clinical Trials Design for Medical Devices Malvern, PA
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June 25 & 26
Good Monitoring Practices for Medical Devices Malvern, PA
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June 25 & 26
Project Management for the Phase 3 and LCM (Life Cycle
Management) of the Drug Development Process Costa
Mesa, CA
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July 2008
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July 7 & 8
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical
Products Costa Mesa, CA
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July 7 & 8
Marketing, Advertising and Promotion of Pharmaceuticals and Medical
Devices Malvern, PA
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July 7 - 9
Current Good Laboratory Practices & Current Good Manufacturing
Practices - A Basic Primer Malvern, PA
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July 7 - 9
Reporting Failure Investigations and Process Deviations
Costa Mesa, CA
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July 10 & 11
Overview of FDA Regulatory Compliance For Medical Devices
Costa Mesa, CA
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July 14 & 15
Analytical Method Validation for Pharmaceutical, Biopharmaceutical,
and Biologics Quality Control Costa Mesa, CA
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July 14 & 15
How to Develop an Effective Complaint Handling and Post Market
Surveillance Program for Drugs and Devices Costa Mesa, CA
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July 16 & 17
How to Prepare for a Systems-based Inspection – Understanding the
FDA’s Risk-based Inspections Approach and Ensuring Compliance
Costa Mesa, CA
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July 17 & 18
FDA Inspections of Clinical Data Systems Costa Mesa, CA
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July 21 & 22
Validation of Computer Systems Malvern, PA
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July 21 - 23
cGMP for Quality Assurance and Quality Control of Pharmaceuticals,
Biopharmaceuticals, and Biologics Malvern, PA
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July 21 - 23
Technical Writing for the Pharmaceutical, Medical Device, and Biotech
Industries Costa Mesa, CA
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July 24 & 25
Stability Programs for Product Shelf Life – From Development to
Approval Malvern, PA
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July 24 & 25
Practical Methods for Project Management Costa Mesa, CA
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| August 2008
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Aug. 4 - 6
Generic Drug Approvals: Preparing an ANDA for First-Cycle Approval
Costa Mesa, CA
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Aug. 11 & 12
Pharmaceutical, Biopharmaceutical, and Biologics Quality Control
Laboratories: A Regulatory Compliance Primer Malvern, PA
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Aug. 13 & 14
Stability Testing of Proteins, Peptides & Other Biomolecules
Malvern, PA
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Aug. 18 & 19
Preparing the CMC Section for NDAs/INDs/CTDs Costa Mesa, CA
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Aug. 18 & 19
FDA Inspections: What to Expect and How to Prepare Costa Mesa,
CA
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Aug. 20 - 22
Process Validation for Medical Devices Costa Mesa, CA
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Aug. 25 & 26
Writing Effective Standard Operating Procedures and Other Process
Documents Malvern, PA
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Aug. 25 - 27
The Drug Development Process - From Discovery to Commercialization
Malvern, PA
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Aug. 27 - 29
Root Cause Analysis for CAPA Malvern, PA
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Aug. 28 & 29
Writing in the Regulated Environment When English Is Your Second Language
Malvern, PA
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| September 2008
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Sept. 8 & 9
Financial Fundamentals for Non-Financial Personnel - How Financial Issues
Impact Business Malvern, PA
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Sept. 8 - 10
ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
Malvern, PA
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Sept. 9 & 10
How to Monitor Clinical Trials for GCP Compliance Malvern, PA
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Sept. 15 - 17
CMC Regulatory Compliance for Biopharmaceuticals and Biologics
Malvern, PA
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Sept. 16 & 17
Best Practices for an Effective Cleaning Validation Program
Malvern, PA
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Sept. 18 & 19
Process Validation for Drugs and Biologics Malvern, PA
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Sept. 22 & 23
Validation of Computer Systems Costa Mesa, CA
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Sept. 22 & 23
Good Laboratory
Practices for Pre-Clinical Testing: Compliance, QA and Audit
Malvern, PA
|
Sept. 22 - 24
Biostatistics for Non-Statisticians Costa Mesa, CA
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Sept. 23 & 24
The EU Clinical Trial Directive Malvern, PA
|
Sept. 24 - 26
The CTD/eCTD: Building the Marketing Application Throughout Clinical
Development Malvern, PA
|
Sept. 25 & 26
European Filing & Registration Procedures Malvern, PA
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| October 2008
|
Oct. 1 & 2
Software Development for Medical Device Professionals
Malvern, PA
|
Oct. 1 - 3
Process Validation for Medical Devices
Malvern, PA
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Oct. 6 & 7
Design Control for Medical Device Professionals
Malvern, PA
|
Oct. 14 & 15
How to Implement Risk Management Principles and Activities Within a
Quality Management System Malvern, PA
|
Oct. 15 - 17
Current Good Laboratory Practices & Current Good Manufacturing
Practices - A Basic Primer Costa Mesa, CA
|
Oct. 15 - 17
cGMP for Quality Assurance and Quality Control of Pharmaceuticals,
Biopharmaceuticals, and Biologics Malvern, PA
|
Oct. 16 & 17
Effective Quality
Assurance Auditing for FDA Regulated Industries Malvern, PA
|
Oct. 16 & 17
Practical Methods for
Project Management Malvern, PA
|
Oct. 20 & 21
Stability Programs for
Product Shelf Life – From Development to Approval Malvern,
PA
|
Oct. 20 - 22
Good Clinical Practices (GCPs)
Malvern, PA
|
Oct. 20 & 21
Effective Document
Management for the Pharmaceutical, Biotech & Medical Device Industries
Malvern, PA
|
Oct. 22 & 23
Dermatological Product
Development Malvern, PA
|
Oct. 23 & 24
Adverse Drug Events –
Reporting & Regulatory Requirements Malvern, PA
|
Oct. 23 & 24
Introduction to Effective
Medical Writing Malvern, PA
|
Oct. 27 & 28
Preparation of FDA
Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and
Communicating with the FDA Malvern, PA
|
Oct. 27 - 29
Biostatistics for
Non-Statisticians Malvern, PA
|
Oct. 29 - 31
QA/QC Strategy for
Biologics and Biopharmaceuticals Malvern, PA
|
Oct. 30 & 31
Introduction to
Statistical Analysis of Laboratory Data Malvern, PA
|
Oct. 30 & 31
Quality Systems
Regulation for the Medical Device & Biotech Industries
Malvern, PA
|
| November
2008
|
Nov. 3 & 4
Marketing, Advertising and
Promotion of Pharmaceuticals and Medical Devices Costa Mesa,
CA
|
Nov. 4 & 5
Latin America –
Understanding Regulatory Compliance Requirements Malvern, PA
|
Nov. 4 & 5
Cleanroom Microbiology for
the Non-Microbiologist Malvern, PA
|
Nov. 6 & 7
Japan - Regulatory Filing
Requirements and Compliance Processes for Life Sciences
Malvern, PA
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Nov. 6 & 7
Sterilization Procedures:
Technology, Equipment and Validation Malvern, PA
|
Nov. 6 & 7
Pharmaceutical Production
Batch Record Review Costa Mesa, CA
|
Nov. 10 & 11
Analytical Method
Validation for Pharmaceutical, Biopharmaceutical, and Biologics
Quality Control Malvern, PA
|
Nov. 10 & 11
How to Develop an
Effective Complaint Handling and Post Market Surveillance Program for
Drugs and Devices Malvern, PA
|
Nov. 10 & 11
Aseptic Processing in the
Manufacture of Biotech and Pharmaceutical Products Malvern,
PA
|
Nov. 10 & 11
Usability Testing for
Medical Device Labeling Costa Mesa, CA
|
Nov. 10 & 11
Writing Effective
Standard Operating Procedures and Other Process Documents
Costa Mesa, CA
|
Nov. 12 & 13
How to Prepare for a
Systems-based Inspection – Understanding the FDA’s Risk-based
Inspections Approach and Ensuring Compliance Malvern, PA
|
Nov. 12 & 13
Stability Testing of
Proteins, Peptides & Other Biomolecules Malvern, PA
|
Nov. 13 & 14
Writing in the Regulated
Environment When English Is Your Second Language Costa Mesa,
CA
|
Nov. 13 & 14
Effective Laboratory
Safety Management Malvern, PA
|
Nov. 13 & 14
Medical Devices: EU
Directives, Guidance, CE Marking and ISO Standard Certifications
Malvern, PA
|
Nov. 17 & 18
Comprehensive Overview of
FDA Regulatory Compliance for Drugs and Biotech Products
Malvern, PA
|
Nov. 17 & 18
Project Management for
Phase 1 & 2 Clinical Trials Malvern, PA
|
Nov. 17 - 19
The Drug Development
Process - From Discovery to Commercialization Malvern, PA
|
Nov. 19 & 20
FDA Inspections: What To
Expect and How To Prepare Malvern, PA
|
Nov. 19 & 20
Project Management for
the Phase 3 and LCM (Life Cycle Management) of the Drug Development
Process Malvern, PA
|
Nov. 19 - 21
Introduction to Molecular
Biology Techniques – Applications in the Biotechnology and
Pharmaceutical Industries Malvern, PA
|
Nov. 20 & 21
FDA Inspections of
Clinical Data Systems Malvern, PA
|
| December 2008
|
Dec. 1 & 2
Overview of FDA Regulatory
Compliance for Medical Devices Malvern, PA
|
Dec. 1 & 2
Clinical Trials Design for
Medical Devices Costa Mesa, CA
|
Dec. 2 & 3
Selecting and Managing CROs
Malvern, PA
|
Dec. 2 & 3
Effective Document
Management for the Pharmaceutical, Biotech & Medical Device Industries
Malvern, PA
|
Dec. 3 & 4
Good Monitoring Practices
for Medical Devices Costa Mesa, CA
|
Dec. 3 & 4
Software Development for
Medical Device Professionals Costa Mesa, CA
|
Dec. 3 - 5
Reporting Failure
Investigations and Process Deviations Malvern, PA
|
Dec. 4 & 5
Drug Master Files (DMFs) - Understanding and Meeting Your
Regulatory and Processing Responsibilities Malvern, PA
|
Dec. 8 & 9
Effective Risk-Based
Applications of Drug cGMPs and Validation Requirements for Cosmetics
and OTC Drug Products Malvern, PA
|
Dec. 8 & 9
Pharmaceutical Maintenance
Management- Understanding cGMPs Malvern, PA
|
Dec. 8 - 10
Technical Writing for the
Pharmaceutical, Medical Device, and Biotech Industries
Malvern, PA
|
Dec. 8 - 10
The CTD/eCTD: Building the
Marketing Application Throughout Clinical Development Costa
Mesa, CA
|
Dec. 10 - 12
Generic Drug Approvals:
Preparing an ANDA for First-Cycle Approval Malvern, PA
|
Dec. 10 - 12
CMC Regulatory Compliance
for Biopharmaceuticals and Biologics Costa Mesa, CA
|
Dec. 11 & 12
Understanding Regulatory
& Clinical Information Systems During Product Development
Costa Mesa, CA
|
Dec. 15 & 16
Preparing the CMC Section
for NDAs/INDs/CTDs Malvern, PA
|
Back
to Top Navigational Aid
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Courses offered in Europe:
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May 2008
|
May 19 & 20
The EU Clinical Trial Directive Berlin, Germany
|
May 19 - 21
Root Cause Analysis for CAPA Dublin, Ireland
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May 21 & 22
European Filing & Registration Procedures Berlin, Germany
|
May 22 & 23
FDA Inspections – What to Expect & How to Prepare
Dublin, Ireland
|
May 22 & 23
Validation of Computer Systems Dublin, Ireland
|
May 26 & 27
How to Implement Risk Management Principles and Activities
Within a Quality Management System Dublin, Ireland
|
| September 2008
|
Sept. 8 & 9
Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and
Biologics Quality Control Berlin, Germany
|
Sept. 8 & 9
Clinical Trials Design for Medical Devices Dublin, Ireland
|
Sept. 9 & 10
Marketing, Advertising and Promotion of Pharmaceuticals and Medical
Devices Berlin, Germany
|
Sept. 10 & 11
Good Monitoring Practices for Medical Devices Dublin, Ireland
|
Sept. 10 - 12
cGMP for Quality Assurance and Quality Control of Pharmaceuticals,
Biopharmaceuticals, and Biologics Berlin, Germany
|
Sept. 15 & 16
Stability Programs for Product Shelf Life – From Development to Approval
Berlin, Germany
|
Sept. 17 & 18
Stability Testing of Proteins, Peptides & Other Biomolecules
Berlin, Germany
|
Sept. 17 & 18
Pharmaceutical Production Batch Record Review Dublin, Ireland
|
Sept. 17 - 19
The Drug Development Process – From Discovery to Commercialization
Dublin, Ireland
|
Sept. 22 - 24
Good Clinical Practices (GCPs) Berlin, Germany
|
Sept. 22 & 23
Design Control for Medical Device Professionals Dublin, Ireland
|
Sept. 22 & 23
Good Distribution Practices (GDP) & Directives: EU/WHO Dublin,
Ireland
|
Sept. 24 & 25
Roles and Responsibilities for GLP Study Directors, QAU & Management
(FDA/OECD) Dublin, Ireland
|
Sept. 25 & 26
Adverse Drug Events – Reporting & Regulatory Requirements
Berlin, Germany
|
| October 2008
|
Oct. 1 - 3
Technical Writing for the Pharmaceutical, Medical Device, and Biotech
Industries Dublin, Ireland
|
Oct. 6 & 7
Writing Effective Standard Operating Procedures and Other Process
Documents Dublin, Ireland
|
Oct. 14 & 15
The EU Clinical Trial Directive
Dublin, Ireland
|
Oct. 16 & 17
European Filing &
Registration Procedures Dublin, Ireland
|
Oct. 20 & 21
Medical Devices: EU
Directives, Guidance, CE Marking and ISO Standard Certifications
Dublin, Ireland
|
Oct. 27 & 28
Process Validation for
Drugs and Biologics Berlin, Germany
|
Oct. 27 - 29
Process Validation for
Medical Devices Berlin, Germany
|
Oct. 29 & 30
Best Practices for an
Effective Cleaning Validation Program Berlin, Germany
|
Oct. 30 & 31
FDA Inspections: What To
Expect and How To Prepare Berlin, Germany
|
| November 2008
|
Nov. 3 & 4
Practical Methods for
Project Management Berlin, Germany
|
Nov. 3 & 4
How to Implement Risk
Management Principles and Activities Within a Quality Management
System Berlin, Germany
|
Nov. 5 & 6
How to Develop an Effective
Complaint Handling and Post Market Surveillance Program for Drugs and
Devices Berlin, Germany
|
Nov. 17 & 18
Drug Master Files (DMFs)
- Understanding and Meeting Your Regulatory and Processing
Responsibilities Berlin, Germany
|
Nov. 19 & 20
Selecting and Managing CROs
Berlin, Germany
|
| December 2008
|
Dec. 1 - 3
Current Good Laboratory
Practices & Current Good Manufacturing Practices - A Basic Primer
Berlin, Germany
|
Dec. 4 & 5
Perspectives on Good
Laboratory and Manufacturing Practices for Pre-Clinical Testing:
Compliance, QA and Audit Berlin, Germany
|
Back
to Top Navigational Aid |
