Online Compliance Training, FDA compliance training, Risk Management for medical device

Establish and Maintain an Effective Supplier Qualification Program

Instructor: David R Dills Recorded Session Access recorded sessions unlimited viewing for 6 months.

21 CFR Part 11 Complying with: Step by Step

Instructor: Chinmoy Roy Recorded Session Access recorded sessions unlimited viewing for 6 months.

The Infamous Form FDA 483: How you respond can make or break you

Instructor: Casper E Uldriks Recorded Session Access recorded sessions unlimited viewing for 6 months.

The Sunshine Act Reporting for Clinical Trials

Instructor: Mukesh Kumar Recorded Session Access recorded sessions unlimited viewing for 6 months.

Project Management for Computer Systems Validation

Instructor: Angela Bazigos Recorded Session Access recorded sessions unlimited viewing for 6 months.

FDA Inspection: Preparation and Management

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

Draft Guidance for Device Industry and FDA - Postmarket Surveillance

Instructor: David R Dills Recorded Session Access recorded sessions unlimited viewing for 6 months.

Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles

Instructor: Jeff Schwegman Recorded Session Access recorded sessions unlimited viewing for 6 months.

Bulletproofing your cGXP Documentation from Audit Citations

Instructor: Chinmoy Roy Recorded Session Access recorded sessions unlimited viewing for 6 months.

FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List

Instructor: David R Dills Recorded Session Access recorded sessions unlimited viewing for 6 months.

Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements

Instructor: Mukesh Kumar Recorded Session Access recorded sessions unlimited viewing for 6 months.

Scale Up and Cycle Transfer for Lyophilization Cycles

Instructor: Jeff Schwegman Recorded Session Access recorded sessions unlimited viewing for 6 months.

Quality Management Systems for Medical Devices and IVDs

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

How to withstand an FDA audit of your facility

Instructor: Mukesh Kumar Recorded Session Access recorded sessions unlimited viewing for 6 months.

How FDA Inspection Observations are Reviewed for Regulatory Action

Instructor: Luis Chavarria Recorded Session Access recorded sessions unlimited viewing for 6 months.

Current Concepts & Challenges in Cloud Compliance

Instructor: Angela Bazigos Recorded Session Access recorded sessions unlimited viewing for 6 months.

GMP Vendor Audits

Instructor: Dr. James R Harris Recorded Session Access recorded sessions unlimited viewing for 6 months.

cGMP for Medical Devices Including In Vitro Diagnostic Medical Devices

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

The Hitchhiker's guide to 483s and Warning Letters

Instructor: Angela Bazigos Recorded Session Access recorded sessions unlimited viewing for 6 months.

A Practical Look at the Sarbanes - Oxley (SOX) Act of 2002

Instructor: Chris Doxey Recorded Session Access recorded sessions unlimited viewing for 6 months.

Implementing Design control for Medical Devices and IVDs

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

Computerized System Validation: Basic Concepts

Instructor: Harry Huss Recorded Session Access recorded sessions unlimited viewing for 6 months.

Container – Closure Systems for Lyophilized Products

Instructor: Jeff Schwegman Recorded Session Access recorded sessions unlimited viewing for 6 months.

Designing And Implementing The Quality System From Scratch

Instructor: Howard T Cooper Recorded Session Access recorded sessions unlimited viewing for 6 months.

510(k): Format, Contents and Case Studies

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

Internal GMP Audits

Instructor: Dr. James R Harris Recorded Session Access recorded sessions unlimited viewing for 6 months.

Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

Instructor: Harry Huss Recorded Session Access recorded sessions unlimited viewing for 6 months.

How To Conduct a Successful Process Validation

Instructor: Dr. James R Harris Recorded Session Access recorded sessions unlimited viewing for 6 months.

Optimized Formulation Development for Lyophilized Products

Instructor: Jeff Schwegman Recorded Session Access recorded sessions unlimited viewing for 6 months.

Best Practices for MDRs, Recalls, Corrections, and Removals

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

21 CFR 11 Compliance for Excel Spreadsheets

Instructor: Angela Bazigos Recorded Session Access recorded sessions unlimited viewing for 6 months.

Quality SOPs: Guidelines to developing and writing FDA Compliant Documents

Instructor: Chitra Edwin Recorded Session Access recorded sessions unlimited viewing for 6 months.

Use GAMP to Surefire your CSV Audit

Instructor: Chinmoy Roy Recorded Session Access recorded sessions unlimited viewing for 6 months.

FDA Investigations and Inspections

Instructor: Luis Chavarria Recorded Session Access recorded sessions unlimited viewing for 6 months.

Critical SOPs for Clinical Sites

Instructor: Mukesh Kumar Recorded Session Access recorded sessions unlimited viewing for 6 months.

How to Implement a Risk Management Process

Instructor: Chris Doxey Recorded Session Access recorded sessions unlimited viewing for 6 months.

Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter

Instructor: Jeff Kasoff Recorded Session Access recorded sessions unlimited viewing for 6 months.

How to Survive a DEA Inspection Series: Controlled Substances and Hospitals

Instructor: Carlos M. Aquino Recorded Session Access recorded sessions unlimited viewing for 6 months.

Improving 510(k) Submission Quality

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

Best Practices for Purchasing and Supplier Controls in the Medical Device Industry

Instructor: Jeff Kasoff Recorded Session Access recorded sessions unlimited viewing for 6 months.

How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

Instructor: Carlos M. Aquino Recorded Session Access recorded sessions unlimited viewing for 6 months.

Best Practices Compliant with the FDA Regulations for Handling Medical Device Complaints

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

How to Survive a DEA Inspection Series: Due Diligences of a Pharmacy

Instructor: Carlos M. Aquino Recorded Session Access recorded sessions unlimited viewing for 6 months.

Risk Management for Medical Devices: ISO 14971:2007

Instructor: Ron Schoengold Recorded Session Access recorded sessions unlimited viewing for 6 months.

Writing USFDA-acceptable Clinical Trial Protocols

Instructor: Mukesh Kumar Recorded Session Access recorded sessions unlimited viewing for 6 months.

FDA Regulatory Control of the Drug Development Process and Investigator Responsibility in the Process

Instructor: Dr Charles H Pierce Recorded Session Access recorded sessions unlimited viewing for 6 months.

Lyophilization Process Development and Cycle Design

Instructor: Jeff Schwegman Recorded Session Access recorded sessions unlimited viewing for 6 months.

10 Steps to Perfect SOPs: FDA Acceptable SOPs made Easy

Instructor: Mukesh Kumar Recorded Session Access recorded sessions unlimited viewing for 6 months.

510(k): How To Navigate Through Hurdles And Get It Cleared

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

How to Survive a DEA Inspection Series - Law Enforcement and Pain Management

Instructor: Carlos M. Aquino Recorded Session Access recorded sessions unlimited viewing for 6 months.

IND Submission for a 505(b)(2) Product

Instructor: Mukesh Kumar Recorded Session Access recorded sessions unlimited viewing for 6 months.

The Role of Lab Data in the Drug Development Process: Adverse Events and Subject Safety

Instructor: Dr Charles H Pierce Recorded Session Access recorded sessions unlimited viewing for 6 months.

510(k): Submission and Clearance

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

How to Survive a DEA Inspection Series: Pharmacy Records and Security

Instructor: Carlos M. Aquino Recorded Session Access recorded sessions unlimited viewing for 6 months.

Best Practices and FDA-Compliant Medical Device Reports (MDRs), Recall, Corrections and Removals

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

How to Survive a DEA Inspection Series - For Manufacturers and Distributors

Instructor: Carlos M. Aquino Recorded Session Access recorded sessions unlimited viewing for 6 months.

Best Practices for Establishing a Compliant Medical Device and Complaint Handling System

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.

How to Survive a DEA Inspection Series: DEA Due Diligence for Manufacturers and Distributors

Instructor: Carlos M. Aquino Recorded Session Access recorded sessions unlimited viewing for 6 months.

510(k) Submission: Contents and Format for Medical Devices

Instructor: David Lim Recorded Session Access recorded sessions unlimited viewing for 6 months.