Pharmaceutical Regulations Training Bundle for Regulatory Affairs Professionals

As a regulatory affairs professional, you work to understand the regulations that apply to your organization and set up systems to ensure your organization complies with those regulations. Integrating compliance goals into day-to-day operations requires a thorough understanding of legislation and regulations.

Pharmaceutical regulators have also issued guidelines that allows for innovation and potential cost reductions in manufacturing operations. As today's guidance is translated into tomorrow's regulations, a thorough understanding of the new guidance and a commitment to embed it in the way your company works can provide a competitive advantage.

ComplianceOnline has engaged elite experts and ex-FDA officials to provide detailed knowledge in specific regulations for you and your team through the following training bundle. This bundle is suitable for both new and seasoned regulatory affairs professionals who want to understand specifics of key pharmaceutical regulations.

• See what’s covered in the training bundle
• Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971
• ICH Stability Requirements and Challenges
• Deviations, Investigations and CAPA - The latest FDA and EMA Hot Area for Citations, Warning Letters and Other Actions
• Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
• An Introduction to FDA's Regulation of Over-the-Counter (OTC) Drug Products
• Understanding CFR Part 210-211 Requirements for Drug Products
• Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971
• This training will Cover principles and provides examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

Areas Covered in the Webinar:

• Quality Risk Management Overview
• Understanding Risk
• Definitions and Concepts ICH Q9 and ISO 14971
• Risk Assessment
• Risk Control
• Risk Communication
• Risk Review
• Example of Risk Management Methods and Tools
• Define Pharmaceutical Excipients
• ICH Stability Requirements and Challenges
• Learn how to design stability programs for your drug product, and the analytical methods requirements.

Areas Covered in the Webinar:

Background and Overview of ICH Q1

• What are the requirements for stability programs
• What are the analytical method requirements, what needs to be measured
• Stability indicating methods - what are they?

Designing Stability Studies

• Standard programs vs matrixing vs. bracketing
• ANDA stability requirements

Data Analysis

• Tracking and trending
• OOS vs OOT
• Setting specifications and shelf life
• Deviations, Investigations and CAPA - The latest FDA and EMA Hot Area for Citations, Warning Letters and Other Actions
• Gain valuable assistance on how to avoid costly regulatory action from agencies when your facilities are inspected.

Areas Covered in the Webinar:

• The various types of deviations, discrepancies, Out of Specification and Out of Trends, action limits and alerts.
• The impact of these excursions on your operations and product.
• To identify the lightning rods that will lead the inspector to scrutinize your reports and investigations.
• To differentiate planned and unplanned deviations and manage them appropriately to your advantage.
• The tools of the investigation process and how much investigation is too much.
• How to establish good documentation practices in investigations and CAPA?
• To tie investigation results into operations and dispositioning materials.
• How to write a good CAPA and then track progress and effectiveness.
• To know when an investigation and CAPA are completed.
• Where a good CAPA system can be used in other systems.
• Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
• Learn the objectives of GLPs and how are they associated with GMPs and SOPs, statistical procedures for data evaluation, Instrumentation validation, and Analytical and laboratory certification

Areas Covered in the Webinar:

• GLP: Good Laboratory Practice
• GLP is an FDA Regulation Training
• Definition of GLPs
• History of GLPs
• Why was GLP Created?
• Objectives of GLP
• Mission of GLP
• Instrumentation Validation
• Analyst Certification
• Laboratory Certification
• Grounds for Disqualification
• Consequences of Noncompliance
• Reinstatement of a Disqualified Facility
• An Introduction to FDA's Regulation of Over-the-Counter (OTC) Drug Products
• Learn the various options for marketing an OTC drug, gain an understanding of FDA’s labeling and promotional rules, and strategies for mitigating the potential risk for FDA regulatory enforcement.

Areas Covered in the Webinar:

• FDA's regulation of over-the-counter drug products or OTC drugs.
• Bringing an OTC drug to market under an OTC monograph.
• Where to find FDA's list of existing monographs and identification of the various product categories covered by monographs.
• An introduction to FDA's Rx-to-OTC Switch procedures and the benefits/challenges of pursuing such an option.
• Labeling an OTC drug product.
• Potential FDA enforcement risks.
• Understanding CFR Part 210-211 Requirements for Drug Products
• This webinar will discuss in detail all parts of the regulations set forth in part 210 and in parts 211 of 21 CFR chapters. You will learn how to comply with these regulations.

Areas Covered in the Webinar:

• What is CFR? The history and reason.
• How to apply and comply with 21 CFR Parts 210-211.
• Review most common CGMP deficiencies and FDA Observation.
• Help manufacturers meet requirements of the Agency’s current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211).