Why Biotechnology Quality and Safety training? - Top 6 Reasons

Poor quality is often the result of lack of training. With the appropriate training in Quality and safety, you have a much higher chance of reaping the following top 6 benefits and more.

1. Training helps you comply with the regulatory requirements

It is necessary for biotechnology organizations to establish, manage and monitor their quality control and quality assurance systems to provide high-quality products and services that fully meet customer needs and expectations. While the purpose of quality control is to fulfill the quality requirements, the purpose of quality assurance is to provide confidence that the quality requirements are met.

The management and individuals involved in ensuring quality must have the required knowledge and skills to ensure that the quality systems are adequate, suitable, effective and efficient. Biotechnology Quality and Safety Compliance training programs equip organizations and individuals in achieving the required quality systems.

Here are some examples of Biotechnology training in quality and safety

• CDISC Mapping 2: ODM, MindMaps and References
• Good Documentation Guideline (Chapter <1029> USP)
• How to Conduct Annual Product Reviews to Achieve GMP Compliance
• Container Closure Systems for Liquid and Lyophilized Products
• CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps


2. It helps you stay current with the evolving regulatory changes

Regulatory changes in biotechnology are common. One of the best ways to be well-equipped for quality systems assistance compliance is to take a proactive approach to implement the regulatory developments by attending training programs designed by industry-active experts.

Some examples of training programs that are focused on evolving regulatory changes:

• FDA's Expectations from Supplier Management for GMP: Quality Agreements and More
• New and Expected Guidances on Data Standards and Electronic Submissions for Drugs and Medical Products
• Good Documentation Guideline (Chapter <1029> USP)


3. It increases efficiency at work and enhances career prospects

Biotechnology quality and safety professionals who elevate their work and quality efficiency are in great demand. Training programs are invaluable in increasing efficiency at work and they greatly improve your career prospects.

Some examples of training programs that help improve quality efficiency:

• Human Error Investigations, Root Cause Determination and CAPA Effectiveness
• CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
• How to Prepare a Standard Operating Procedure (SOP)?

Our training programs in biotechnology quality systems include areas such as laboratory control, investigation management, materials management, document control and training.

4. It supplements your academic curriculum with subjects relevant to quality control, quality assurance and total quality management

Basic academic qualifications are no longer enough to perform well at the workplace. Specialized training programs go a long way in equipping participants for high-performance. Especially, quality professionals will find it beneficial to attend training programs focused toward quality management, Pharmaceutical microbiology and validation, Quality management in analytical laboratories, good practices in research, development and production of pharmaceutical products, Biological production from genetics to downstream processing, Food technology and food safety.

Some examples of quality control, quality management, quality assurance training programs

• Performing Effective Management Review of the Quality System
• Critical Elements of Quality Risk Management Relating to FDA Compliance
• Quality by Design


5. It minimizes risk

The biotech industry is no stranger to risk. Risk management is a critical component of a quality management system. By attending risk management training programs with content developed and delivered by subject matter experts, biotech companies are helped in managing their risk.

• Building and institutionalizing risk management into the pharmaceutical supply chain
• Risk Assessments - Key to a Viral Safety Management Plan
• Critical Elements of Quality Risk Management Relating to FDA Compliance
• Risk Based Approach in cGMP - Quality Risk Management (QRM)
• Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971
• Supplier Qualification Audit, A Risk Based Approach
• Conducting a risk assessment for objectionable microorganisms


6. It satisfies specific training needs that may arise or evolve

A training need may suddenly arise or evolve in your organization. Instead of hiring new staff, your organization may choose to promote or move professionals within the system with background and experience in related area of work. That's where our course can be of great help.

Here are some examples of role specific courses

• Assay Validation for Clinical Diagnostics
• Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training
• Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents
• Steam Sterilization Microbiology and Autoclave Performance Qualification

More programs here>>>

If you can't find a training program that exactly meets your needs, please contact us. Our trainers design custom training programs to meet your requirements.

The next steps

For Individuals - Gain the skills essential for an excellent biotechnology career

Whether you are looking to learn a new regulatory requirement, or understand a specific process, or upgrade your current skills, or move up the career ladder, our resources and training programs in Biotechnology Quality and Safety Regulatory Compliance will be invaluable in achieving your goals.

For Organizations - Manage Performance and Risk

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  Every year thousands of biotechnology professionals choose ComplianceOnline for their career development.
• Learn from Experienced Industry-Active Experts
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  Whether you want to attend a live seminar, webinar or access an on-demand recording, our training, we'll help you every step of the way.