Eventura World

HUMAN ERROR PREVENTION TRAINING - PREVENTING ACTIVE AND LATENT ERROR IN THE LIFE SCIENCES

Dates: JUNE 20 - 21, 2022

Course Director: CHARLES H PAUL

CSV VS CSA - WATERFALL VS. AGILE METHODOLOGY, DOCUMENTATION AND IMPLEMENTATION

Dates: JUNE 23 - 24, 2022

Course Director: CAROLYN TROIANO

VIEW SEMINAR DETAIL

VERIFICATION AND VALIDATION - PRODUCT, EQUIPMENT / PROCESS, SOFTWARE AND QMS

Dates: JUNE 27 - 28, 2022

Course Director: JOHN E LINCOLN

ANALYTICAL INSTRUMENT QUALIFICATION & VALIDATION – USE OF EXCEL AND FDA AUDIT PREPARATION

Dates: JULY 7 - 8, 2022

Course Director: JOY MCELROY

FDA INSPECTION ESSENTIALS IN 2022

Dates: JULY 14 - 15, 2022

Course Director: DANIELLE DELUCY

A TO Z OF ANALYTICAL METHOD VALIDATION, VERIFICATION AND TRANSFER

Dates: JULY 21 - 22, 2022

Course Director: KELLY THOMAS

SUPPLIER AND CONTRACT MANUFACTURER MANAGEMENT

Dates: AUGUST 4 - 5, 2022

Course Director: JOSE I. MORA

BUILDING A ROBUST VENDOR QUALIFICATION PROGRAM FOR FDA REGULATED INDUSTRIES

Dates: AUGUST 11 - 12, 2022

Course Director: JOY MCELROY

COMPUTER SYSTEM VALIDATION (CSV) AND DATA INTEGRITY FOR CLINICAL TRIALS REGULATED BY FDA

Dates: AUGUST 15 - 16, 2022

Course Director: CAROLYN TROIANO

VIEW SEMINAR DETAIL

21 CFR PART 11 DATA INTEGRITY TRAINING FOR SAAS/CLOUD, EU GDPR - HOW TO REDUCE COSTS FOR COMPLIANCE

Dates: AUGUST 25 - 26, 2022

Course Director: DAVID NETTLETON

TECHNICAL WRITING MASTERCLASS IN THE LIFE SCIENCES

Dates: SEPTEMBER 8 - 9, 2022

Course Director: CHARLES H PAUL

AUDIT LIKE THE FDA - EFFECTIVE INTERNAL AUDIT PROGRAM

Dates: SEPTEMBER 12 - 13, 2022

Course Director: SUSANNE MANZ

COMPUTER SYSTEM VALIDATION (CSV) BOOT CAMP

Dates: SEPTEMBER 28 - 30, 2022

Course Director: CAROLYN TROIANO

PROCESS VALIDATION TRAINING COURSE (FDA AND EU ANNEX 15: QUALIFICATIONS, VALIDATION AND PRACTICAL IMPLEMENTATION)

Dates: OCTOBER 3 - 4, 2022

Course Director: JOY MCELROY

GLP LABORATORY COMPLIANCE DOCUMENTATION AND RECORDKEEPING

Dates: OCTOBER 3 - 4, 2022

Course Director: DR. JOHN C. FETZER

SOP WRITING, TRAINING AND COMPLIANCE IN THE PHARMACEUTICAL INDUSTRY

Dates: OCTOBER 3 - 4, 2022

Course Director: MICHAEL ESPOSITO

VIEW SEMINAR DETAIL

24May

Step-by-Step Process for Successful Sterility Failure Investigations

$250.00
5/24/2022 01:00 PM - 5/24/2022 02:15 PM
Online Event

Faculty: Danielle DeLucy

25May

Is My Data Abnormal? Normality Tests and Transformations

$200.00
5/25/2022 01:00 PM - 5/25/2022 02:30 PM
Online Event

Faculty: Elaine Eisenbeisz

01Jun

Measurement Uncertainty in Microbiology

$250.00
6/1/2022 01:00 PM - 6/1/2022 02:00 PM
Online Event

Presenter: Michael Brodsky

02Jun

3-Hour Virtual Seminar on Design Controls for Medical Devices

$392.00
6/2/2022 01:00 PM - 6/2/2022 04:00 PM
Online Event

Faculty: Susanne Manz

06Jun

Pharma Curriculum Development Using a Learning Management System (LMS)

$250.00
6/6/2022 01:00 PM - 6/6/2022 02:00 PM
Online Event

Faculty: Michael Esposito

08Jun

Pharmacokinetics (PK) / Pharmacodynamics (PD) Studies in Drug Discovery and Development

$183.00
6/8/2022 03:00 PM - 6/8/2022 04:00 PM
Online Event

Faculty: Dr. Stefano Persiani

08Jun

Fundamental Of Pharmacokinetics

$200.00
6/8/2022 03:00 PM - 6/8/2022 04:00 PM
Online Event

Faculty: Dr. Stefano Persiani

09Jun

GMP Audits – Tools and Techniques

$250.00
6/9/2022 01:00 PM - 6/9/2022 02:00 PM
Online Event

Faculty: Carl Patterson

10Jun

ANDA Submission and GDUFA Final FDA Guidance

$200.00
6/10/2022 01:00 PM - 6/10/2022 02:00 PM
Online Event

Faculty: Charles Paul

14Jun

Excel Spreadsheets – Ensuring Data Integrity and 21 CFR Part 11 Compliance

$250.00
6/14/2022 01:00 PM - 6/14/2022 02:15 PM
Online Event

Faculty: David Nettleton

14Jun

Effective Design of Experiments (DOE) Strategies

$250.00
6/14/2022 01:00 PM - 6/14/2022 02:00 PM
Online Event

Faculty: José Mora

15Jun

Instrumental Issues in GC and GC-MS for On-Going Validation

$250.00
6/15/2022 01:00 PM - 6/15/2022 02:00 PM
Online Event

Faculty: Dr. John C. Fetzer

17Jun

6-Hour Virtual Seminar on Computer System Validation for Cloud and COTS Applications

$522.00
6/17/2022 10:00 AM - 6/17/2022 04:00 PM
Online Event

Faculty: Carolyn Troiano

20Jun

Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

$250.00
6/20/2022 01:00 PM - 6/20/2022 02:30 PM
Online Event

Faculty: Joy McElroy

21Jun

How to Apply for a Breakthrough Therapy Designation and Win It

$250.00
6/21/2022 01:00 PM - 6/21/2022 02:00 PM
Online Event

Faculty: Carolyn Troiano

22Jun

Medical Device Hazard Analysis following ISO 14971

$200.00
6/22/2022 11:00 AM - 6/22/2022 12:30 PM
Online Event

Faculty: Edwin Waldbusser

30Jun

3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations

$392.00
6/30/2022 11:00 AM - 6/30/2022 02:00 PM
Online Event

Faculty: Danielle DeLucy

23May

3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations

$392.00
5/23/2022 11:00 AM - 5/23/2022 02:00 PM
Online Event

Faculty: Danielle DeLucy

19May

3-Hour Virtual Seminar on Complaint Handling and Medical Device Reporting and Recalls

$392.00
5/19/2022 12:00 PM - 5/19/2022 03:00 PM
Online Event

Faculty: Susanne Manz

18May

FDA Good Laboratory Practices (GLP’s)

$200.00
5/18/2022 01:00 PM - 5/18/2022 02:30 PM
Online Event

Faculty: John E. Lincoln

17May

Master the Vendor Auditing of your Computer Systems Regulated by FDA

$250.00
5/17/2022 01:00 PM - 5/17/2022 02:30 PM
Online Event

Faculty: Carolyn Troiano

17May

Key Elements of HPLC and UPLC Method Validation to Ensure Compliance with FDA and ISO Requirements

$250.00
5/17/2022 11:00 AM - 5/17/2022 12:00 PM
Online Event

Faculty: Dr. John C. Fetzer

16May

Risk-Based Environmental Monitoring (EM) Program

$200.00
5/16/2022 01:00 PM - 5/16/2022 02:30 PM
Online Event

Faculty: Kelly Thomas

16May

How to Write Effective 483 and Warning Letter Responses

$200.00
5/16/2022 01:00 PM - 5/16/2022 02:30 PM
Online Event

Faculty: Kelly Thomas

13May

How to Prepare a 510(k) Submission

$200.00
5/13/2022 01:00 PM - 5/13/2022 02:00 PM
Online Event

Faculty: Edwin Waldbusser

13May

3 Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

$392.00
5/13/2022 01:00 PM - 5/13/2022 04:00 PM
Online Event

Faculty: Carolyn Troiano

12May

Understanding and Implementing a Quality by Design (QbD) Program

$200.00
5/12/2022 01:00 PM - 5/12/2022 02:00 PM
Online Event

Faculty: Steven Laurenz

12May

3-Hour Virtual Seminar on U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs

$392.00
5/12/2022 01:00 PM - 5/12/2022 04:00 PM
Online Event

Presenter: John E. Lincoln

10May

4-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance

$392.00
5/10/2022 12:00 PM - 5/10/2022 04:00 PM
Online Event

Presenter: Carolyn Troiano

09May

3-Hour Virtual Seminar on Human Error Prevention in the Life Sciences

$372.00
5/9/2022 01:00 PM - 5/9/2022 04:00 PM
Online Event

Presenter: Charles Paul

09May

4-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

$392.00
5/9/2022 11:00 AM - 5/9/2022 02:00 PM
Online Event

Faculty: Danielle DeLucy

06May

Ensuring your Site is Ready for an FDA Inspection

$183.00
5/6/2022 01:00 PM - 5/6/2022 02:30 PM
Online Event

Faculty: Susanne Manz

How To Implement An Effective Human Error Reduction Program

$200.00
5/5/2022 01:00 PM - 5/5/2022 02:30 PM
Online Event

Faculty: Dr. Ginette Collazo

Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

$200.00
5/5/2022 01:00 PM - 5/5/2022 02:00 PM
Online Event

Faculty: Carl Patterson

Process Failure Mode Effects Analysis and Control Plan

$200.00
5/5/2022 01:00 PM - 5/5/2022 02:00 PM
Online Event

Faculty: William Levinson

04May

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

$392.00
5/4/2022 01:00 PM - 5/4/2022 04:00 PM
Online Event

Faculty: Susanne Manz

03May

Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

$200.00
5/3/2022 01:00 PM - 5/3/2022 02:15 PM
Online Event

Faculty: David Nettleton

03May

3-Hour Virtual Seminar on Computer System Validation (CSV) vs Computer Software Assurance (CSA) – Following a Waterfall vs Agile Methodology

$392.00
5/3/2022 12:00 PM - 5/3/2022 03:00 PM
Online Event

Faculty: Carolyn Troiano

02May

Packaging and Labeling in Pharmaceutical Product Development – Best Practices

$200.00
5/2/2022 01:00 PM - 5/2/2022 02:00 PM
Online Event

Faculty: Michael Esposito

02May

Process Validation Guidance Requirements, FDA, EU Annex 15, Qualification and Validation – 4 Hours Virtual Seminar

$492.00
5/2/2022 11:00 AM - 5/2/2022 03:00 PM
Online Event

Faculty: Joy McElroy

28Apr

3-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries

$392.00
4/28/2022 01:00 PM - 4/28/2022 04:00 PM
Online Event

Faculty: Joy McElroy

28Apr

3-Hour Virtual Seminar on Successful Deviation Investigations

$392.00
4/28/2022 11:00 AM - 4/28/2022 02:00 PM
Online Event

Faculty: Danielle DeLucy

27Apr

Calculations for Process and Product Capability

$200.00
4/27/2022 01:00 PM - 4/27/2022 02:30 PM
Online Event

Faculty: Elaine Eisenbeisz

26Apr

Effective Handling of Issues in Calibrations and Accuracy under GLP

$200.00
4/26/2022 01:00 PM - 4/26/2022 02:00 PM
Online Event

Faculty: Dr. John C. Fetzer

26Apr

Good Documentation Practices

$200.00
4/26/2022 01:00 PM - 4/26/2022 02:15 PM
Online Event

Faculty: Danielle DeLucy

25Apr

6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries

$695.00
4/25/2022 10:00 AM - 4/25/2022 04:00 PM
Online Event

Faculty: Joy McElroy

22Apr

3-Hour Virtual Seminar on Bad Standard Operating Procedures (SOPs) – Bad Training: Garbage In, Garbage Out

$392.00
4/22/2022 12:00 PM - 4/22/2022 03:00 PM
Online Event

Faculty: Michael Esposito

20Apr

Test Method Validation to Verify your Device Performance

$200.00
4/20/2022 01:00 PM - 4/20/2022 02:00 PM
Online Event

Presenter : José Mora

13Apr

3-Hour Virtual Seminar on cGMP Regulatory Inspections – Through the Eyes of FDA, EMA and PMDA

$392.00
4/13/2022 01:00 PM - 4/13/2022 04:00 PM
Online Event

Faculty: Kelly Thomas

12Apr

New Drug Applications (NDA’s), Investigational New Drugs (IND’s) and the Drug cGMP’s

$200.00
4/12/2022 01:00 PM - 4/12/2022 02:30 PM
Online Event

Faculty: John E. Lincoln

11Apr

Effective Use of Biomarkers in Drug Discovery and Development

$183.00
4/11/2022 03:00 PM - 4/11/2022 04:00 PM
Online Event

Faculty: Dr. Stefano Persiani

07Apr

Sterilization of Pharmaceutical Products and Medical Devices

$200.00
4/7/2022 01:00 PM - 4/7/2022 02:00 PM
Online Event

Faculty: Carl Patterson

05Apr

2-Hour Comprehensive Seminar on Measurement Systems Analysis

$290.00
4/5/2022 01:00 PM - 4/5/2022 03:00 PM
Online Event

Faculty: William Levinson

28Mar

Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach

$200.00
3/28/2022 01:00 PM - 3/28/2022 02:30 PM
Online Event

Faculty: Joy McElroy

22Mar

Statistical Process Control through the use of control charts and Nelson’s Rules

$183.00
3/22/2022 01:00 PM - 3/22/2022 02:00 PM
Online Event

Faculty: Dr. John C. Fetzer

21Mar

ICH Q7 – GMPs for Active Pharmaceutical Ingredients

$200.00
3/21/2022 01:00 PM - 3/21/2022 02:30 PM
Online Event

Faculty: John E. Lincoln

17Mar

Implementation of a Successful Technology Transfer Process

$200.00
3/17/2022 01:00 PM - 3/17/2022 02:00 PM
Online Event

Faculty: Steven Laurenz

17Mar

Successful Deviation Investigations

$240.00
3/17/2022 01:00 PM - 3/17/2022 02:15 PM
Online Event

Faculty: Danielle DeLucy

11Mar

6-Hour Virtual Seminar on Statistics for Process Control

$522.00
3/11/2022 10:00 AM - 3/11/2022 04:00 PM
Online Event

Faculty: Elaine Eisenbeisz

10Mar

FDA Regulations and Requirements for Artificial Intelligence / Machine Learning

$200.00
3/10/2022 01:00 PM - 3/10/2022 02:00 PM
Online Event

Faculty: José Mora

10Mar

How To Reduce Human Error Once And For All – Investigations, Root Cause Determination and CAPA Effectiveness

$200.00
3/10/2022 01:00 PM - 3/10/2022 02:30 PM
Online Event

Faculty: Dr. Ginette Collazo

03Mar

Objectionable Microorganisms in Biopharmaceutical Production – Identification and Risk Mitigation

$183.00
3/3/2022 01:00 PM - 3/3/2022 02:00 PM
Online Event

Faculty: Carl Patterson

03Mar

4-Hour Virtual Seminar on Batch Record Review and Product Release

$392.00
3/3/2022 10:00 AM - 3/3/2022 02:00 PM
Online Event

Faculty: Danielle DeLucy

02Mar

Extractables And Leacheables In Drug Development

$183.00
3/2/2022 03:00 PM - 3/2/2022 04:00 PM
Online Event

Faculty: Dr. Stefano Persiani

01Mar

Zero Acceptance Sampling to Reduce Inspection Costs

$183.00
3/1/2022 01:00 PM - 3/1/2022 02:00 PM
Online Event

Faculty: William Levinson

22Feb

Analytical Method Validation under Good Laboratory Practices (GLPs)

$200.00
2/22/2022 01:00 PM - 2/22/2022 02:00 PM
Online Event

Faculty: Dr. John C. Fetzer

16Feb

Root Cause Analysis (RCA) in the Laboratory – Addressing Non-Conformances

$200.00
2/16/2022 12:00 PM - 2/16/2022 01:00 PM
Online Event

Faculty: Michael Brodsky

11Feb

4-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

$452.00
2/11/2022 12:00 PM - 2/11/2022 04:00 PM
Online Event

Presenter: Carolyn Troiano

11Feb

6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

$522.00
2/11/2022 10:00 AM - 2/11/2022 04:00 PM
Online Event

Presenter: Elaine Eisenbeisz

10Feb

Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies

$200.00
2/10/2022 01:00 PM - 2/10/2022 02:30 PM
Online Event

Faculty: Elaine Eisenbeisz

10Feb

Aseptic Processing and Techniques 101

$200.00
2/10/2022 01:00 PM - 2/10/2022 02:00 PM
Online Event

Faculty: Carl Patterson

08Feb

Remote Auditing for Medical Device Companies

$200.00
2/8/2022 01:00 PM - 2/8/2022 02:00 PM
Online Event

Faculty: Susanne Manz

08Feb

Project Management Utilizing Principles of Lean Documents and Lean Configuration

$200.00
2/8/2022 01:00 PM - 2/8/2022 02:30 PM
Online Event

Faculty: José Mora

08Feb

3-Hour Virtual Seminar on Statistical Process Control (SPC), Process Capability, and Non-Normal Distributions

$392.00
2/8/2022 01:00 PM - 2/8/2022 04:00 PM
Online Event

Faculty: William Levinson

07Feb

Onboarding In A GMP Environment – Best Practices

$200.00
2/7/2022 01:00 PM - 2/7/2022 02:30 PM
Online Event

Faculty: Michael Esposito

07Feb

4-Hour Virtual Seminar on Aseptic Processing and Validation

$398.00
2/7/2022 12:00 PM - 2/7/2022 04:00 PM
Online Event

Presenter: Kelly Thomas

03Feb

Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

$200.00
2/3/2022 01:00 PM - 2/3/2022 02:00 PM
Online Event

Presenter: Carolyn Troiano

02Feb

Effective Genotoxic Impurities Assessment In Drug Development

$283.00
2/2/2022 03:00 PM - 2/2/2022 04:00 PM
Online Event

Faculty: Dr. Stefano Persiani

01Feb

Cybersecurity – FDA Requirements Masterclass

$230.00
2/1/2022 01:00 PM - 2/1/2022 02:30 PM
Online Event

Faculty: John E. Lincoln

01Feb

Latest Trends in Controlling Human Error in the Manufacturing Floor

$200.00
2/1/2022 01:00 PM - 2/1/2022 02:30 PM
Online Event

Faculty: Dr. Ginette Collazo

28Jan

GMPs for Medical Marijuana Production Operations Cannabis GMP

$212.00
1/28/2022 01:00 PM - 1/28/2022 02:00 PM
Online Event

Faculty: Charles Paul

25Jan

Power Analysis for Sample Size Calculations

$183.00
1/25/2022 01:00 PM - 1/25/2022 02:30 PM
Online Event

Faculty: Elaine Eisenbeisz

21Jan

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

$200.00
1/21/2022 01:00 PM - 1/21/2022 02:30 PM
Online Event

Faculty: Kelly Thomas

19Jan

Writing Followable Procedures – Avoid Procedure Related Deviations

$295.00
1/19/2022 01:00 PM - 1/19/2022 02:30 PM
Online Event

Presenter: Dr. Ginette Collazo

18Jan

How To Conduct A Human Factors/Usability Validation

$200.00
1/18/2022 01:00 PM - 1/18/2022 02:00 PM
Online Event

Faculty: José Mora

18Jan

3-Hour Virtual Seminar on Effective CAPA within a Device Quality System

$392.00
1/18/2022 01:00 PM - 1/18/2022 04:00 PM
Online Event

Faculty: Susanne Manz

13Jan

Sunshine Act Reporting – Clarification for Clinical Research

$200.00
1/13/2022 01:00 PM - 1/13/2022 02:15 PM
Online Event

Faculty: Danielle DeLucy

13Jan

Environmental Monitoring Investigation Techniques for Effective Contamination Control

$200.00
1/13/2022 01:00 PM - 1/13/2022 02:00 PM
Online Event

Faculty: Carl Patterson

Establishing and Regaining Control of Cleanroom

$200.00
1/12/2022 01:00 PM - 1/12/2022 02:30 PM
Online Event

Faculty: Joy McElroy

Secrets to Writing Effective SOPs for QMS

$200.00
1/12/2022 01:00 PM - 1/12/2022 02:30 PM
Online Event

Faculty: Susanne Manz

Analytical Microbiology – Contract Lab vs In-House Lab – How to Overcome the Corporate Dilemma

$195.00
1/12/2022 12:00 PM - 1/12/2022 01:00 PM
Online Event

Faculty: Michael Brodsky

11Jan

Introduction to Design of Experiments

$200.00
1/11/2022 01:00 PM - 1/11/2022 02:00 PM
Online Event

Faculty: William Levinson

17Dec

Root Cause Analysis and CAPA

$200.00
12/17/2021 01:00 PM - 12/17/2021 02:00 PM
Online Event

Faculty: William Levinson

15Dec

Human Factors Engineering to Satisfy the New IEC 62366-1, -2

$200.00
12/15/2021 01:00 PM - 12/15/2021 02:30 PM
Online Event

Faculty: John E. Lincoln

14Dec

Medical Device Cybersecurity Following Latest FDA Guidance

$200.00
12/14/2021 01:00 PM - 12/14/2021 02:00 PM
Online Event

Faculty: Edwin Waldbusser

09Dec

Sterilization of Pharmaceutical Products and Medical Devices

$200.00
12/9/2021 01:00 PM - 12/9/2021 02:00 PM
Online Event

Faculty: Carl Patterson

08Dec

Risk-based Design Control – The New Paradigm for Medical Device Design

$200.00
12/8/2021 01:00 PM - 12/8/2021 02:30 PM
Online Event

Faculty: José Mora

07Dec

Secrets to Writing Effective SOPs for Medical Device QMS

$200.00
12/7/2021 01:00 PM - 12/7/2021 02:30 PM
Online Event

Faculty: Susanne Manz

07Dec

Expediting Approval for Regenerative Drugs and Breakthrough Therapy Designation

$200.00
12/7/2021 01:00 PM - 12/7/2021 02:30 PM
Online Event

Faculty: Carolyn Troiano

06Dec

CE Marking in the EU – Latest Regulations

$200.00
12/6/2021 01:00 PM - 12/6/2021 02:00 PM
Online Event

Faculty: Charles Paul

03Dec

3-Hour Virtual Seminar on Computer System Validation (CSV) vs Computer Software Assurance (CSA) - Following a Waterfall vs Agile Methodology

$392.00
12/3/2021 12:00 PM - 12/3/2021 03:00 PM
Online Event

Faculty: Carolyn Troiano

21 CFR Part 11 Compliance for Electronic Records and Signatures

$200.00
12/1/2021 11:00 AM - 12/1/2021 12:00 PM
Online Event

Presenter: Carolyn Troiano

19Nov

Building a Compliant Documentation and Training System – 3 Hours Virtual Seminar

$400.00
11/19/2021 01:00 PM - 11/19/2021 04:00 PM
Online Event

Faculty: Charles Paul

19Nov

3-Hour Virtual Seminar on Effective CAPA within a Device Quality System

$392.00
11/19/2021 01:00 PM - 11/19/2021 04:00 PM
Online Event

Presenter: Susanne Manz

18Nov

Quality Risk Management Overview

$183.00
11/18/2021 01:00 PM - 11/18/2021 02:00 PM
Online Event

Faculty: Steven Laurenz

17Nov

Layered Process Audits for USFDA Regulated Industries

$200.00
11/17/2021 01:00 PM - 11/17/2021 02:30 PM
Online Event

Faculty: John E. Lincoln

16Nov

Effective Design of Experiments (DOE) Strategies

$200.00
11/16/2021 01:00 PM - 11/16/2021 02:00 PM
Online Event

Presenter: José Mora

16Nov

4-Hour Virtual Seminar on Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs

$452.00
11/16/2021 12:00 PM - 11/16/2021 04:00 PM
Online Event

Faculty: Carolyn Troiano

12Nov

Post-Market Surveillance Activities (FDA and EU-MDR) – A Detailed Analysis

$900.00
11/12/2021 01:00 PM - 11/12/2021 02:30 PM
Online Event

Presenter: Susanne Manz

12Nov

3-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

$392.00
11/12/2021 11:00 AM - 11/12/2021 02:00 PM
Online Event

Presenter: Danielle DeLucy

05Nov

3-Hour Virtual Seminar on Process Validation for Drugs and Biologics

$400.00
11/5/2021 01:00 PM - 11/5/2021 04:00 PM
Online Event

Faculty: Joy McElroy

29Oct

Computer System Validation Masterclass

$350.00
10/29/2021 11:30 PM - 10/30/2021 05:00 AM
Online Event

Faculty: G. Sundar

20Oct

Human Factors Usability Studies Following ISO 62366 and New FDA Guidance

$200.00
10/20/2021 01:00 PM - 10/20/2021 02:00 PM
Online Event

Faculty: Edwin Waldbusser

19Oct

Do’s and Don’ts in Effectively Dealing with Difficult Customers

$160.00
10/19/2021 01:00 PM - 10/19/2021 02:00 PM
Online Event

Faculty: Dr. John C. Fetzer

19Oct

Additive / 3D Printing Manufacturing and Its Regulatory Issues

$250.00
10/19/2021 01:00 PM - 10/19/2021 02:00 PM
Online Event

Faculty: John E. Lincoln

14Oct

Statistical Elements of Small Sample Sizes and Only 3 Lots in Process or Product Validation

$200.00
10/14/2021 01:00 PM - 10/14/2021 02:30 PM
Online Event

Faculty: Elaine Eisenbeisz

07Oct

Production and Process Controls for Medical Devices

$200.00
10/7/2021 01:00 PM - 10/7/2021 02:30 PM
Online Event

Faculty: Susanne Manz

04Oct

US vs EU – Medical Devices Compliance and Regulatory Affairs

$200.00
10/4/2021 01:00 PM - 10/4/2021 02:00 PM
Online Event

Presenter : Charles Paul

01Oct

Auditing for Microbiological Aspects in Pharmaceutical Manufacturing

$200.00
10/1/2021 01:00 PM - 10/1/2021 02:00 PM
Online Event

Presenter : Carl Patterson

24Sep

6-Hour Virtual Seminar on Statistics for Quality Control

$522.00
9/24/2021 10:00 AM - 9/24/2021 04:00 PM
Online Event

Faculty: Elaine Eisenbeisz

22Sep

Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration

$200.00
9/22/2021 01:00 PM - 9/22/2021 02:30 PM
Online Event

Faculty: José Mora

21Sep

Blockchain Innovations that Connect and Protect the Supply Chain

$183.00
9/21/2021 01:00 PM - 9/21/2021 02:30 PM
Online Event

Faculty: John E. Lincoln

21Sep

FDA Regulation of Artificial Intelligence / Machine Learning

$200.00
9/21/2021 01:00 PM - 9/21/2021 02:00 PM
Online Event

Faculty: Edwin Waldbusser

20Sep

4-Hour Virtual Seminar on Write SOP’s and Work Instructions that Really Work

$522.00
9/20/2021 12:00 PM - 9/20/2021 04:00 PM
Online Event

Faculty: Charles Paul

08Sep

3-Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC

$392.00
9/8/2021 01:00 PM - 9/8/2021 04:00 PM
Online Event

Faculty: José Mora

28Aug

6-Hour Virtual Seminar on QbD and Technology Transfer Program – A Practical Approach to Successful Implementation

$150.00
8/28/2021 12:30 AM - 8/28/2021 06:30 AM
Online Event

Faculty: HitendraKumar Shah

23Aug

3-Hour Virtual Seminar on Technical Training in Life Sciences

$312.00
8/23/2021 01:00 PM - 8/23/2021 04:00 PM
Online Event

Faculty: Charles Paul

18Aug

3-Hour Virtual Seminar on Controlling Human Error in Manufacturing Floor

$392.00
8/18/2021 12:00 PM - 8/18/2021 03:00 PM
Online Event

Presenter: Dr. Ginette Collazo

17Aug

SDLC Modernization Continuous Quality in an FDA-Regulated Environment and Journey to Paperless SDLC/CSV

$200.00
8/17/2021 01:00 PM - 8/17/2021 02:30 PM
Online Event

Faculty: Carolyn Troiano

14Aug

6-Hour Virtual Seminar on Annual Product Quality Reviews – Preparation, Reports, Impact of Latest Quality Metrics Guidance

$150.00
8/14/2021 12:30 AM - 8/14/2021 06:30 AM
Online Event

Faculty: HitendraKumar Shah

13Aug

Writing Effective SOPs for QMS

$183.00
8/13/2021 01:00 PM - 8/13/2021 02:00 PM
Online Event

Faculty: Carl Patterson

13Aug

3-Hours Virtual Seminar – Technical Writing for the Regulated Industries

$392.00
8/13/2021 12:00 PM - 8/13/2021 03:00 PM
Online Event

Faculty: Joy McElroy

12Aug

Changing Up Performance Reviews

$132.00
8/12/2021 01:00 PM - 8/12/2021 02:30 PM
Online Event

Presenter: Teri Morning

09Aug

FDA’s Plan for Modernizing the 510(k) Pathway – Meet the New Expectations

$200.00
8/9/2021 01:00 PM - 8/9/2021 02:30 PM
Online Event

Faculty: John E. Lincoln

09Aug

4-Hour Virtual Seminar on Project Management for Non-Project Managers

$322.00
8/9/2021 12:00 PM - 8/9/2021 04:00 PM
Online Event

Faculty: Charles Paul

04Aug

Leaning In to the Power of a Remote or Mobile Workplace

$122.00
8/4/2021 01:00 PM - 8/4/2021 02:00 PM
Online Event

Presenter: Teri Morning

04Aug

Effective Standard Operating Procedure (SOPs) Development

$200.00
8/4/2021 01:00 PM - 8/4/2021 02:15 PM
Online Event

Faculty: Danielle DeLucy

27Jul

Investigative Report Writing and Documentation – Crucial Pieces of a Professional Investigation

$125.00
7/27/2021 01:00 PM - 7/27/2021 02:15 PM
Online Event

Presenter: Teri Morning

24Jul

4-Hour Virtual Seminar on FDA Inspection Readiness – Be Ready!

$322.00
7/24/2021 12:00 PM - 7/24/2021 04:00 PM
Online Event

Presenter: Charles Paul

20Jul

Process Validation Requirements and Compliance Strategies

$200.00
7/20/2021 01:00 PM - 7/20/2021 02:00 PM
Online Event

Faculty: José Mora

29Jun

Laboratory Controls – Anticipate the Systems Based FDA Inspection

$240.00
6/29/2021 01:00 PM - 6/29/2021 02:15 PM
Online Event

Faculty: Danielle DeLucy

21Jun

Clinical Quality Auditing

$200.00
6/21/2021 01:00 PM - 6/21/2021 02:30 PM
Online Event

Faculty: Pam Dellea-Giltner

17Jun

Process Risk Management Strategies – Reduce Risk and COGS While Improving Yield and Compliance

$220.00
6/17/2021 01:00 PM - 6/17/2021 02:30 PM
Online Event

Faculty: Dr. Ronald D. Snee

16Jun

Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience

$200.00
6/16/2021 01:00 PM - 6/16/2021 02:00 PM
Online Event

Faculty: Edwin Waldbusser

03Jun

Process Validation LifeCycle

$240.00
6/3/2021 01:00 PM - 6/3/2021 02:15 PM
Online Event

Faculty: Danielle DeLucy

26May

FDA’s Latest UDI Labeling Requirements

$200.00
5/26/2021 01:00 PM - 5/26/2021 02:30 PM
Online Event

Faculty: John E. Lincoln

26May

Good Documentation Practices for Clinical Trials

$200.00
5/26/2021 01:00 PM - 5/26/2021 02:30 PM
Online Event

Faculty: Pam Dellea-Giltner

25May

Good Documentation Practices to Support Computer System Validation

$200.00
5/25/2021 01:00 PM - 5/25/2021 02:15 PM
Online Event

Faculty: Carolyn Troiano

20May

Selecting Right Statistical Tools to Solve Problems

$230.00
5/20/2021 01:00 PM - 5/20/2021 02:30 PM
Online Event

Faculty: Dr. Ronald D. Snee

19May

Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration

$200.00
5/19/2021 01:00 PM - 5/19/2021 02:30 PM
Online Event

Faculty: José Mora

18May

Successful Change Control Management

$230.00
5/18/2021 01:00 PM - 5/18/2021 02:15 PM
Online Event

Faculty: Danielle DeLucy

18May

FDA Regulated Mobile Medical Apps as Devices and Cybersecurity Explained

$183.00
5/18/2021 01:00 PM - 5/18/2021 02:00 PM
Online Event

Faculty: Edwin Waldbusser

Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration

$200.00
5/5/2021 01:00 PM - 5/5/2021 02:30 PM
Online Event

Faculty: José Mora

04May

Biosafety and Blood borne Pathogen Safety in the Lab

$180.00
5/4/2021 01:00 PM - 5/4/2021 02:15 PM
Online Event

Presenter: Danielle DeLucy

28Apr

FDA’s 21 CFR Part 11 Add-on Inspections

$200.00
4/28/2021 01:00 PM - 4/28/2021 02:30 PM
Online Event

Presenter: John E. Lincoln

26Apr

3-Hour Virtual Seminar on GCP ICH E6 R2 Addendum and Impact on Selection and Managing Vendors in Clinical Research

$392.00
4/26/2021 01:00 PM - 4/26/2021 04:00 PM
Online Event

Presenter: Pam Dellea-Giltner

22Apr

Measurement, Analysis, and Improvement for safe and Effective Medical Devices

$183.00
4/22/2021 01:00 PM - 4/22/2021 02:30 PM
Online Event

Presenter : Susanne Manz

20Apr

Statistical Process Control through the use of control charts and Nelson’s Rules

$183.00
4/20/2021 01:00 PM - 4/20/2021 02:00 PM
Online Event

Faculty: Dr. John C. Fetzer

15Apr

FDA’s Medical Device De Novo Reclassification Process

$200.00
4/15/2021 01:00 PM - 4/15/2021 02:00 PM
Online Event

Faculty: Charles Paul

13Apr

Virtual Site Audits for FDA Regulated Industries

$200.00
4/13/2021 01:00 PM - 4/13/2021 02:30 PM
Online Event

Faculty: John E. Lincoln

08Apr

Steam Sterilization Microbiology and Autoclave Performance Qualification

$220.00
4/8/2021 01:00 PM - 4/8/2021 02:15 PM
Online Event

Faculty: Danielle DeLucy

07Apr

Internal Audit – How Best to Perform Them

$200.00
4/7/2021 01:00 PM - 4/7/2021 02:30 PM
Online Event

Presenter : Kenneth Christie

23Mar

3-Hour Virtual Seminar on Master Validation Plan – The Unwritten Requirements

$312.00
3/23/2021 01:00 PM - 3/23/2021 04:00 PM
Online Event

Faculty: John E. Lincoln

23Mar

4-Hour Virtual Seminar on Design Control Program with Detailed Hazard Analysis, Human Factors and Software Discussions

$452.00
3/23/2021 12:00 AM - 3/23/2021 04:00 PM
Online Event

Faculty: Edwin Waldbusser

18Mar

3-Hour Virtual Seminar on Root Cause Analysis for CAPA Investigations

$392.00
3/18/2021 01:00 PM - 3/18/2021 04:00 PM
Online Event

Faculty: Dr. Ronald D. Snee

18Mar

Supplier Quality Management Simplified

$200.00
3/18/2021 01:00 PM - 3/18/2021 02:30 PM
Online Event

Faculty: José Mora

17Mar

Current Regulatory Requirements for Aseptically Produced Products

$200.00
3/17/2021 01:00 PM - 3/17/2021 02:30 PM
Online Event

Faculty: Kenneth Christie

10Mar

Is it Microbiological Method Verification or Validation, or Just Semantics?

$183.00
3/10/2021 12:00 PM - 3/10/2021 01:00 PM
Online Event

Faculty: Michael Brodsky

09Mar

4-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

$452.00
3/9/2021 11:00 AM - 3/9/2021 03:00 PM
Online Event

Faculty: Carolyn Troiano

05Mar

FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

$200.00
3/5/2021 01:00 PM - 3/5/2021 02:30 PM
Online Event

Faculty: Kenneth Christie

04Mar

Ensuring your Site is Ready for an FDA Inspection

$183.00
3/4/2021 01:00 PM - 3/4/2021 02:30 PM
Online Event

Faculty: Susanne Manz

25Feb

The Annual Validation Summit - Compliance Trainings

$699.00
2/25/2021 10:00 AM - 2/27/2021 03:00 PM
Online Event

As we continue to monitor the global impact of COVID-19, and as the world evolves, so do we. We are transforming this event to be fully digital: The Annual Validation Summit 2021 - Virtual. Timings: 10 AM to 3 PM GMT

18Feb

4-Hour Virtual Seminar on Batch Record Review and Product Release

$392.00
2/18/2021 10:00 AM - 2/18/2021 02:00 PM
Online Event

Faculty: Danielle DeLucy

16Feb

Requirements for IQ, OQ and PQ Quality Protocols

$200.00
2/16/2021 01:00 PM - 2/16/2021 02:30 PM
Online Event

Faculty: Kenneth Christie

05Feb

Regulatory Expectations for Environmental Monitoring Programs

$210.00
2/5/2021 01:00 PM - 2/5/2021 02:30 PM
Online Event

Presenter : Kenneth Christie

04Feb

Secrets to Writing Effective SOPs for Medical Device QMS

$200.00
2/4/2021 01:00 PM - 2/4/2021 02:30 PM
Online Event

Faculty: Susanne Manz

02Feb

Conducting an Effective Software Validation of Medical Device to Meet FDA Requirements

$183.00
2/2/2021 01:00 PM - 2/2/2021 02:00 PM
Online Event

Faculty: Edwin Waldbusser

28Jan

Solving Statistical Mysteries – What does the FDA want

$200.00
1/28/2021 01:00 PM - 1/28/2021 02:30 PM
Online Event

Faculty: Dr. Ronald D. Snee

26Jan

3-Hour Virtual Seminar on Controlling Human Error in Manufacturing Floor

$392.00
1/26/2021 12:00 PM - 1/26/2021 03:00 PM
Online Event

Faculty: Dr. Ginette Collazo

19Jan

Process Validation Requirements and Compliance Strategies

$200.00
1/19/2021 01:00 PM - 1/19/2021 02:00 PM
Online Event

Faculty: José Mora

19Jan

Examining and Implementation of ISO 13485:2016 Medical Device Quality Management System

$200.00
1/19/2021 01:00 PM - 1/19/2021 02:30 PM
Online Event

Faculty: John E. Lincoln

14Jan

Quality Control for Analytical Materials used in Microbiology Laboratories

$183.00
1/14/2021 01:00 PM - 1/14/2021 02:00 PM
Online Event

Faculty: Michael Brodsky

FDA Computer System Audit – Best Preparation Practices

$250.00
1/12/2021 01:00 PM - 1/12/2021 02:00 PM
Online Event

Faculty: Carolyn Troiano

07Jan

Good Documentation Practices – What Helps Make Your Controlled Documents Compliant

$200.00
1/7/2021 01:00 PM - 1/7/2021 02:30 PM
Online Event

Faculty: Kenneth Christie

16Dec

Big Data – Tools and Trends for Improving your Quality System

$200.00
12/16/2020 01:00 PM - 12/16/2020 02:00 PM
Online Event

Faculty: Susanne Manz

14Dec

FDA’s Risk Evaluation and Mitigation Strategy (REMS)

$200.00
12/14/2020 01:00 PM - 12/14/2020 02:30 PM
Online Event

Faculty: Kelly Thomas

10Dec

How to Detect Lack of Data Integrity

$200.00
12/10/2020 01:00 PM - 12/10/2020 02:30 PM
Online Event

Faculty: Dr. Ronald D. Snee

08Dec

FDA’s Adverse Event Reporting and Product Recalls

$200.00
12/8/2020 01:00 PM - 12/8/2020 02:15 PM
Online Event

Faculty: Joy McElroy

07Dec

FDA’s Recent Regulation on the Use of Social Media

$200.00
12/7/2020 01:00 PM - 12/7/2020 02:30 PM
Online Event

Faculty: Carolyn Troiano

03Dec

How to conduct Annual Product Reviews to achieve GMP Compliance

$200.00
12/3/2020 01:00 PM - 12/3/2020 02:15 PM
Online Event

Faculty: Danielle DeLucy

17Nov

The Master Validation Plan –The Unwritten Requirements

$200.00
11/17/2020 01:00 PM - 11/17/2020 02:30 PM
Online Event

Faculty: John E. Lincoln

17Nov

4-Hour Virtual Seminar on Quality Control Laboratory Compliance – cGMPs and GLPs

$398.00
11/17/2020 12:00 PM - 11/17/2020 04:00 PM
Online Event

Faculty: Kelly Thomas

10Nov

How to Make Design Part of Your Product Development DNA

$183.00
11/10/2020 01:00 PM - 11/11/2020 02:00 PM
Online Event

Faculty: Tom KraMer

10Nov

3-Hour Virtual Seminar on Effective Cleaning Validation Procedures – Best Practices

$312.00
11/10/2020 12:00 PM - 11/10/2020 03:00 PM
Online Event

Faculty: Joy McElroy

27Oct

Clinical Quality Auditing

$200.00
10/27/2020 01:00 PM - 10/27/2020 02:30 PM
Online Event

Faculty: Pam Dellea-Giltner

23Oct

Making ISO 9001:2015 the Servant, Not the Master

$183.00
10/23/2020 01:00 PM - 10/23/2020 02:00 PM
Online Event

Faculty: William Levinson

22Oct

USP <1224> Transferring the Method to meet Regulatory Expectations

$200.00
10/22/2020 01:00 PM - 10/22/2020 02:00 PM
Online Event

Faculty: Carl Patterson

20Oct

Using Metrics to Monitor and Improve Your Quality System

$200.00
10/20/2020 01:00 PM - 10/20/2020 02:00 PM
Online Event

Faculty: Susanne Manz

20Oct

Human Factors Engineering in New Product Development

$200.00
10/20/2020 01:00 PM - 10/20/2020 02:00 PM
Online Event

Faculty: Tom KraMer

16Oct

MDSAP and EU ISO 13485 Approach – US FDA, Canada Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW

$200.00
10/16/2020 01:00 PM - 10/16/2020 02:00 PM
Online Event

Faculty: Juan M. Campos

15Oct

Training in Human Error: Reducing Training Related Errors

$200.00
10/15/2020 01:00 PM - 10/15/2020 02:30 PM
Online Event

Faculty: Ginette Collazo

14Oct

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

$200.00
10/14/2020 01:00 PM - 10/14/2020 02:30 PM
Online Event

Faculty: Joy McElroy

08Oct

Medical Device Cybersecurity and FDA Compliance - How to Avoid Your Medical Device Being Hacked

$200.00
10/8/2020 01:00 PM - 10/8/2020 02:30 PM
Online Event

Faculty: Carolyn Troiano

07Oct

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

$200.00
10/7/2020 01:00 PM - 10/7/2020 02:00 PM
Online Event

Faculty: Joy McElroy

07Oct

Is it Microbiological Method Verification or Validation, or Just Semantics?

$183.00
10/7/2020 12:00 PM - 10/7/2020 01:00 PM
Online Event

Faculty: Michael Brodsky

30Sep

3-Hour Virtual Seminar On How To Prepare An Effective SOP – Workshop With Case Study

$200.00
9/30/2020 09:00 AM - 9/30/2020 12:00 PM
Online Event

Faculty: Dr. Tarun Chugh

29Sep

Quality Control for Analytical Materials used in Microbiology Laboratories

$200.00
9/29/2020 12:00 PM - 9/29/2020 01:00 PM
Online Event

Faculty: Michael Brodsky

29Sep

Verification vs Validation – Product, Process or Equipment and QMS Software

$200.00
9/29/2020 11:00 AM - 9/29/2020 12:30 PM
Online Event

Faculty: John E. Lincoln

28Sep

IEC 62304 and Effective Software Validation

$125.00
9/28/2020 09:00 AM - 9/28/2020 10:30 AM
Online Event

Faculty: Lakshman Prakash

24Sep

3-Hour Virtual Seminar On Media Fill – Avoiding And Overcoming Media Fill Failures

$200.00
9/24/2020 09:00 AM - 9/24/2020 12:00 PM
Online Event

Faculty: Dr. Tarun Chugh

15Sep

EU MDR Implementation Delay due to Pandemic and its effects

$200.00
9/15/2020 01:00 PM - 9/15/2020 02:30 PM
Online Event

Faculty: John E. Lincoln

15Sep

3-Hour Virtual Seminar on Controlling Human Error in Manufacturing Floor

$392.00
9/15/2020 12:00 PM - 9/15/2020 03:00 PM
Online Event

Faculty: Dr. Ginette Collazo

12Sep

Handling OOS Test Results And Robust Investigations

$125.00
9/12/2020 09:00 AM - 9/12/2020 10:30 AM
Online Event

Faculty: Sundar Ganesan

11Sep

Measurement Systems Analysis

$183.00
9/11/2020 01:00 PM - 9/11/2020 02:00 PM
Online Event

Faculty: William Levinson

28Aug

Building a Compliant Documentation and Training System

$219.00
8/28/2020 01:00 PM - 8/28/2020 02:00 PM
Online Event

Presenter : Charles Paul

27Aug

Monitoring and Validation of Pharmaceutical Water Systems

$200.00
8/27/2020 01:00 PM - 8/27/2020 02:00 PM
Online Event

Presenter : Carl Patterson

25Aug

How to Prepare for and Host a FDA Inspection and Respond to 483’s

$183.00
8/25/2020 01:00 PM - 8/25/2020 02:00 PM
Online Event

Presenter : Edwin Waldbusser

24Aug

ISO 14971:2019 Medical Device Hazards and Risk Management – All you need to know

$200.00
8/24/2020 01:00 PM - 8/24/2020 02:30 PM
Online Event

Presenter : John E. Lincoln

24Aug

Biopharmaceutical Analytics – Regulations and Validation

$200.00
8/24/2020 01:00 PM - 8/24/2020 02:30 PM
Online Event

This exclusive Pack of webinars contain 7 courses: 1. Laboratory Controls – Anticipate the Systems Based FDA Inspection 2. Analytical Method Validation and Transfer 3. Auditing Laboratory Data Systems 4. Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance 5. Handling OOS Test Results and Completing Robust Investigations 6. Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries 7. Establishing a Product Stability Testing Program Total Duration: 12 Hours

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5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada

What is the difference between Asceptic Processing and Terminal Sterilization ?

11/25/2020 11:08 AM

Aseptic process is carried out usually throughout the production and it also makes sure quality is built into it. It is carefully monitored all along to make sure that quality is built.

11/25/2020 11:00 AM

Many different ways are used to sterilize Medical Devices like usage of moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods for instance, chlorine dioxide gas, vaporized peracetic acid, and nitrogen

11/25/2020 10:54 AM

GLP and GMP are at times confused as the same as it pertains to Laboratory testing. It is understandable that both cover Lab Testing still are different. Knowing the difference becomes very important here.

11/25/2020 05:52 AM

Inspection of ambulatory surgical facilities that perform LASIK procedures is one of the options available to FDA to ensure that physicians and patients have current and accurate information to help them with their decisions about LASIK. These inspections allow FDA to identify reporting problems and provide opportunities to further educate user facilities about MDR reporting obligations.

11/24/2020 12:46 AM

A recall means that the FDA and/or a manufacturer is aware of a problem with a device that could affect patient safety and health. Most manufacturers voluntarily recall medical devices that are found to have created health risks, but the FDA has the right under law to issue the recall if the company does not do so, or refuses to do so, which is rare. The recall may be related to a correction on a device or total removal of the device from the market.

11/23/2020 01:04 AM

The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. In other words, when the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval

11/18/2020 08:32 AM

Sterlization plays a very vital and crucial role in Medical Industry. Most commonly used methods are the Heat Method, Filteration , Radiation Sterilization and Chemical Method.

11/18/2020 08:22 AM

11/18/2020 01:57 AM

Medical gloves were designed to serve as protective barriers and may still offer some protection even when they are used beyond the manufacturer’s designated shelf life or expiration date.

11/17/2020 12:14 AM

EUA is a tool used by FDA to authorize the temporary use of products that fulfill urgent medical needs during public health emergencies. These products are authorized for use only in specific circumstances and expire once those conditions end.

11/16/2020 02:31 AM

An ambulatory surgical facility is a distinct entity whose primary purpose is to furnish same day outpatient surgical services to patients. A facility that offers LASIK as one of its ophthalmic surgical procedures may also provide non-ophthalmic surgical services. Consider all surgical services provided by a facility when determining whether a facility meets the MDR definition of an ambulatory surgical facility and is therefore subject to the user facility obligations under MDR.

11/13/2020 02:14 AM

The Solidarity Trial is an international clinical trial to help find an effective treatment for COVID-19, launched by WHO and partners. It is hoped that one or more of the treatments under trial will result in improving clinical outcomes in COVID-19 patients and save lives. Other trials are on-going around the world in addition to the Solidarity Trial.

FDA issues draft guidance on drug interaction studies with acid-reducing agents

12/2/2020 08:58 AM

Today, the Food and Drug Administration issued a draft guidance for industry, “Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.” The guidance assists sponsors of investigational new drug applications and new drug applications during drug development in evaluating the need for and design of drug-drug interaction (DDI) studies involving acid-reducing agents (ARAs).

JW to conduct clinical trials of gout treatment in China

12/2/2020 08:55 AM

JW Pharmaceutical said Wednesday its gout treatment, URC102, has won the approval to conduct clinical trials in China from the National Medical Products Administration. Under the clinical plan, Simcere, JW’s partner company, tests safety, resistance and other factors on 40 healthy Chinese participants at Shanghai Public Health Clinical Center.

FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer

12/2/2020 08:45 AM

Today, the U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

FDA approves pralsetinib for RET-altered thyroid cancers

12/2/2020 08:37 AM

On December 1, 2020, the Food and Drug Administration approved pralsetinib (GAVRETO, Blueprint Medicines Corporation) for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Dr Reddy’s and RDIF begin clinical trials for Sputnik V vaccine in India

12/2/2020 07:39 AM

Dr Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) announced that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India. This will be a multicentre and randomised controlled study, which will include safety and immunogenicity study.

Scientists discover possible genetic target for treating endometriosis

12/2/2020 06:25 AM

Researchers have identified a potential genetic target for treating an especially painful and invasive form of endometriosis. Michigan State University researchers have identified a potential genetic target for treating an especially painful and invasive form of endometriosis.

Medicare Payments Could Get Tougher for Docs

12/2/2020 05:20 AM

More than 40 value-based payment models — from direct contracting to bundled payments — have been introduced into the Medicare program in the past 10 years, with the goal of improving care while lowering costs. Hopes were high that they would be successful.

FDA launches Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program to support use of novel drug development tools

12/1/2020 07:23 AM

ay, the U.S. Food and Drug Administration launched the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for developers of novel drug development tools (DDTs). This pilot creates a pathway for developers to submit proposals for novel approaches that do not have an existing regulatory path.

Hasina-Modi` virtual meeting likely on December 17

12/1/2020 07:11 AM

According to sources at the Ministry of Foreign Affairs and the Indian High Commission in Dhaka, the chances of the virtual meeting between the two prime ministers taking place on December 17 are as much as 90%.

Vegpro International Issues a Recall of Fresh Attitude Baby Spinach Because of Potential Salmonella Health Risk

12/1/2020 06:58 AM

Vegpro International of Sherrington, QC CAN is recalling Fresh Attitude baby spinach (5oz and 11oz) with Best before dates of Dec 4th (for 11oz) and Dec 4th & 5th (for the 5oz), because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.