Pharma Focus Asia

Advanced Program in Pharmaceutical Quality Management

Encompassing ICH, WHO, FDA and Quality 4.0 Requirements and Best Industry Practices

India is the world’s third largest pharmaceutical generics producer with the highest number of FDA and MHRA GMP-approved manufacturing plants outside the U.S. and Europe. The challenge of remaining in GMP compliance continues to be the main concern. India has seen a resurgence of breach of data integrity and quality issues. Regulatory requirements continue to become more stringent and rigorous.

Technical and QA professionals in India are trained in GMP compliance mainly through experience and need a formal education in pharmaceutical quality management of international standards.

  • Sixty-four percent of companies say a shortage of skilled staff is curtailing their growth (Deloitte).
  • ‘There is an urgent need for more effective training, coaching and mentoring to remove fear and empower.’ (Dr. Azaj Hussain, former U.S. FDA Deputy Director of the Office of Pharmaceutical Science)
  • We live in a world of ‘brutal disruption’. The pandemic – what next? The regulatory landscape will continue to change, and prosperity awaits those who can do the basics to Ph.D. level

HOW THIS TRAINING CAN HELP

This unique, world-class program will provide the training needed to comply with GMP regulations. Course modules are very interactive and led by world-class, international experts. You will learn best-in-class practices and apply them in practical problem-solving and real-life case studies. You will learn by doing.

In addition to module-specific content, you will be provided with a deep understanding of simplification, risk-based decision making and advanced problem-solving skills. You will receive practical instruction on the leadership and communication skills required to add value to your organisation and to successfully interact with regulatory agencies in the U.S. and EU and other key stakeholders.

Indian Drug Manufacturers’ Association (IDMA) has been, since its inception in 1961, the engine leading the Indian Pharmaceutical Industry to greater heights and glory and ensuring near self-sufficiency of affordable quality medicines for our people and also globally. We have a membership of 1100 plus and 8 State Boards in large pharma cluster areas pan India. IDMA, as the apex national body of Pharmaceutical and API manufacturers in our country is the only Association comprising of small, medium and large scale pharmaceutical manufacturers situated throughout the length and breadth of our country and is rightly known as the “Voice of the National Sector”.

IDMA along with NSF Health Sciences, UK boldly stated that APPQM, the unique, World-Class education program will Develop Change Agents for Quality Excellence.  Series One & Two lived up to the expectations of the industry. Over 40 delegates attended Series One (Physical)  & 28 delegates attended Series Two (Virtual).

For more infromation, Please find the below PDF.

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