Pertecnica Engineering stands as a beacon of excellence in India’s employee training landscape, distinguished for its bespoke modules catering specifically to the pharmaceutical industry. These meticulously crafted programs are designed to equip professionals with the latest knowledge, skills, and regulatory insights crucial for success in the ever-evolving pharmaceutical sector.
Pertecnica’s training repertoire encompasses a broad spectrum, covering essential areas such as Good Manufacturing Practices (GMP), Quality Control, Research and Development methodologies, and compliance with stringent industry standards. With a keen focus on innovation, safety, and compliance, Pertecnica Engineering ensures that participants gain comprehensive expertise, empowering them to contribute significantly to the advancement and growth of the pharmaceutical industry in India and beyond.
We offer following job skills
- Good Manufacturing Practices (GMP), List of Different Courses on GMP: GMP programs cover the principles and regulations governing pharmaceutical manufacturing, ensuring product quality and safety.
- Pharmaceutical Sales and Marketing List of Different Marketing Courses: Sales and marketing professionals in the pharmaceutical industry receive training in product marketing, market access, and customer engagement.
- Pharmaceutical Quality Control and Assurance: Professionals learn about quality control techniques, analytical testing, and quality assurance programs to maintain product quality.
- Pharmaceutical Research and Development (R&D) Training: Training programs address drug discovery, preclinical studies, clinical trials, and drug development processes.
- Pharmaceutical Regulatory Affairs: Training focuses on regulatory requirements, submissions, and compliance with regulatory agencies, such as the FDA and EMA.
- Pharmaceutical Packaging and Labeling Regulations: Professionals receive training in pharmaceutical packaging materials, labeling requirements, and packaging technology.
- Pharmaceutical Process Validation: Training programs cover process validation methods, equipment qualification, and validation documentation.
- Pharmaceutical Laboratory Testing and Analysis: Professionals learn about testing methods and equipment used to evaluate pharmaceutical products for quality and safety.
- Pharmaceutical Auditing and Compliance: Training prepares professionals to conduct audits and assessments of pharmaceutical facilities to ensure regulatory compliance.
- Pharmaceutical Clinical Trials and Good Clinical Practice (GCP): Professionals involved in clinical research learn about clinical trial design, conduct, and GCP guidelines.
- Pharmaceutical Supply Chain and Logistics Management: Training addresses supply chain logistics, inventory management, and distribution strategies specific to the pharmaceutical industry.
- Pharmaceutical Biotechnology and Biopharmaceuticals: Professionals learn about biotechnology processes, including the production of biologics and monoclonal antibodies.
- Pharmaceutical Drug Formulation and Development: Training programs cover the formulation of pharmaceutical dosage forms, such as tablets, capsules, and injections.
- Pharmaceutical Safety and Pharmacovigilance: Professionals learn about drug safety monitoring, adverse event reporting, and pharmacovigilance practices.
- Pharmaceutical Equipment Operation and Maintenance: Operators and maintenance personnel receive training in the safe operation and maintenance of pharmaceutical machinery.
- Pharmaceutical Analytical Chemistry: Training focuses on advanced analytical techniques, such as chromatography and spectroscopy, used in pharmaceutical analysis.
- Pharmaceutical Clinical Data Management: Professionals learn about clinical data collection, management, and analysis for regulatory submissions.
Customized Training Workshops
- FDA compliance training
- Clinical research training
- Biopharmaceutical manufacturing training
- Drug safety training
- Pharmaceutical project management courses
- Medical writing courses
- Pharmaceutical data analytics training
- Pharmaceutical risk management courses
- Pharmaceutical product development courses
- Bioinformatics in pharmaceuticals
- Pharmaceutical technology courses
- Pharmaceutical business analytics training
- Pharmaceutical leadership development
- Pharmacology training courses
- Pharmaceutical e-learning programs
- Pharmaceutical industry certifications
- Calibration of the Instruments
- Qualification of Systems and Equipment
- Market Complaints and Returns
- QA QC of sterile and non sterile formulations
Manufacturing of injectables, capsules, tablets, soft gelatin, pellets
- LIMS Training
- Technology Transfer Pharmaceutical Industry
- Stores and Warehouse Management
For more info…
Duration: Contact us for Customized Training Modules
Methodology: The training will be delivered through a blend of lectures, interactive sessions, case studies, practical workshops, and site visits.
Evaluation: Assessment through quizzes, project presentations, and a final evaluation test.
- Good Laboratory Notebooks Practices
- Sampling protocols
- Process Development Report (PDR)
- Product Development Report (PDR)
- Master Formula Record MFR
- Batch Manufacturing Record BMR
- product Development trials
- Autoclave Design, Operations, Maintenance
- Validation Batches
- Sterilization and Decontamination practices
- Laboratory Reagents
- Machine Setting Methods
- Batch planning
- Track and trace system
- Technology transfer
- OSD
- Cleaning Validation
- Equipment validation
- Computer system Validation
- Chromatography Data Systems
- EDQM
- Incident management
- UV spectrometer
- Manufacturing of Injectables
- NAFDAC
- L2 Integration
- TGA
- IPQA
- ANVISA
- ICH
- 21 CFR Part 11 Compliance in QC Lab and overall plant practices
- Laboratory Instruments such as HPLC, GC, LCMS, GCMS
- Forced degradation study
- Process Optimization ( process , sample to analysis)
- Scale up trials
- Lab trials and its note book review
- pre-formulation activity
- Reverse engineering
- RLD procurement and analysis
- Test licensing process
- Document handling system – In F&D / ADL / Pilot plant and Manufacturing Plant
- GXP, ALCOA, CFR 21
- Elemental impurities
- Field alert reports
- STP cofa
- SOP specs
- CAPA , OOS and OOT
- Modified delayed and controlled release
- WHO Audit
- Handling QAMS
- manufacturing of Capsules
- Micro biological testing
- SVP
- NDA
- Labware LIMS
- Water Testing and Analysis
- Bacterial Endotoxin Testing
- Solubility and bio-availability enhancement of insoluble molecules
- Taste masking and flavour enhancement of consumer health products
- Development of patent non infringing generic formulation
- Dossiers evaluation, In-Vivo, In-Vitro Correlation
- Stability study as per ICH guidelines& shelf life extrapolation in various packages
- Implementation of QBD(QTPP,CMA,CPP) & DOE tool in product development
- Analytical & Formulation results co-relation
- Data Compilations/interpretation reports, SOPs et
- Kaizen Implementation
- stability studies
- Vendor Audits
- EDMS
- ELN
- DM Water Plant
- AMA
- CQA
- Plant Operations
- ICH GCP
- Production Planning
- Lean Manufacturing
- Six Sigma
- GAMP
- Aseptic Techniques
- End to end development support for USFDA generic fomulation and MHRA submission
- CMO
- Manufacturing of tablets